Optimizing One-Lung Ventilation: Prostaglandin E1 Advantage in Oxygenation and Safety, suggests study

In a recent study investigating the effects of prostaglandin E1 (PGE1) on reducing inspired oxygen concentration during one-lung ventilation (OLV), several key findings and outcomes were identified. The study included 120 patients undergoing thoracic surgery, randomly assigned to four groups receiving different FiO2 levels and PGE1 nebulization. The primary outcome was oxygenation during OLV, with secondary outcomes including inflammatory markers, postoperative complications, and hospital stay duration.

Results and Impacts of PGE1 Administration

The results showed that pre-OLV nebulization of PGE1 reduced the required FiO2 during OLV, leading to improved oxygenation and lower incidence of hypoxemia. The nebulized PGE1 groups exhibited delayed decreases in PaO2 and improvements in PaO2/FiO2 ratio compared to the control group. Furthermore, PGE1 inhalation resulted in lower Qs/Qt, reduced inflammatory cytokine levels, and improved clinical pulmonary infection scores. The study concluded that the combined impact of reduced FiO2 and PGE1 administration decreased the risk of hypoxemia and systemic inflammatory responses during OLV.

Importance of Lung Protection and Oxygenation Management

Additionally, the study highlighted the importance of lung protection and oxygenation management during OLV. Clear guidelines on optimal FiO2 levels during OLV are currently lacking, emphasizing the need for strategies to minimize oxidative stress while ensuring adequate oxygenation. The study findings supported the use of PGE1 to optimize oxygenation and reduce systemic inflammation by lowering FiO2 requirements during OLV.

Study Limitations and Recommendations for Further Research

However, the study also identified limitations that warrant further investigation. These include the need for larger sample sizes focused on postoperative complications, exploration of different PGE1 doses, and validation in populations with impaired lung function. Future studies should aim to explore long-term outcomes, diverse PGE1 doses, and the applicability of the recommended regimen across various patient populations.

Conclusive Findings on PGE1 Administration

In conclusion, the study demonstrated that pre-OLV PGE1 administration reduces the required FiO2 during OLV, leading to improved oxygenation, decreased hypoxemia risk, and lowered systemic inflammatory responses. This approach holds promise for optimizing patient outcomes during thoracic surgery by balancing oxygenation needs and minimizing oxidative stress-related complications associated with high FiO2 levels.

Key Points

– Pre-OLV nebulization of prostaglandin E1 (PGE1) reduced the needed FiO2 during one-lung ventilation (OLV), enhancing oxygenation and decreasing hypoxemia.

– Patients receiving PGE1 showed delayed decreases in PaO2, improved PaO2/FiO2 ratio, lower Qs/Qt values, reduced inflammatory cytokine levels, and better clinical pulmonary infection scores.

– Lung protection and oxygenation management during OLV are crucial, with the study underlining the lack of clear guidelines on optimal FiO2 levels.

– The study suggests that PGE1 administration can optimize oxygenation, lower systemic inflammation, and diminish hypoxemia risk by reducing FiO2 requirements during OLV.

– Study limitations include the need for larger sample sizes, exploration of different PGE1 doses, and validation in populations with impaired lung function.

– Conclusively, PGE1 administration pre-OLV holds promise in enhancing patient outcomes during thoracic surgery by balancing oxygenation requirements and minimizing complications related to high FiO2 levels.

Reference –

Lingxi Xing et al. (2025). The Impact Of Different Inspired Oxygen Concentrations Combined With Nebulized Prostaglandin E1 On Oxygenation In Patients Undergoing One-Lung Ventilation: A Randomized Controlled Trial. *BMC Anesthesiology*, 25. https://doi.org/10.1186/s12871-025-03081-3.

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Semaglutide and Liraglutide linked to Elevated Risk of Optic Nerve Damage in Seniors With Type 2 Diabetes: JAMA

USA: A recent research letter published in JAMA Ophthalmology has identified a potential link between certain glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and an elevated risk of nonarteritic anterior ischemic optic neuropathy (NAION) in older adults with type 2 diabetes. The study, led by Kin Wah Fung from the Lister Hill National Center for Biomedical Communications, National Library of Medicine, National Institutes of Health, Bethesda, Maryland, found that semaglutide and liraglutide were particularly associated with higher risks among this drug class.

NAION is the second most frequent cause of vision loss due to optic nerve damage, with advanced age and long-standing type 2 diabetes recognized as major risk factors. Building on previous reports suggesting an association between semaglutide and NAION, the researchers conducted an extensive observational cohort study using data from Medicare enrollees aged 65 years and above who were prescribed antidiabetic medications between 2007 and 2021.

The study led to the following findings:

  • The study analyzed data from over 3.8 million patients with type 2 diabetes.
  • Around 15% of these patients received GLP-1 receptor agonists.
  • Semaglutide (4.9%) and liraglutide (4.2%) were the most commonly prescribed GLP-1 RAs.
  • During a median follow-up of 3.7 years, 0.2% of patients developed nonarteritic anterior ischemic optic neuropathy (NAION).
  • Use of GLP-1 RAs as a class was associated with a higher risk of NAION compared to other second-line antidiabetic drugs.
  • Semaglutide (HR 1.39) and liraglutide (HR 1.25) showed the strongest associations with NAION.
  • The median time between starting GLP-1 RA therapy and NAION diagnosis was 3.3 years.
  • Insulin use was linked to a higher risk of NAION compared with metformin only (HR 1.43).
  • Male sex, White race, and dual Medicare-Medicaid eligibility were associated with increased risk.
  • Rural residence and a history of diabetic retinopathy, chronic kidney disease, or obstructive sleep apnea were the additional risk factors.
  • The use of amiodarone, an antiarrhythmic medication, was also linked to elevated risk.
  • Age did not appear as a significant variable, likely due to the narrow age range of the cohort.

The findings reinforce earlier studies that flagged semaglutide as a potential risk factor for NAION, though the current analysis draws on a substantially larger patient base and a greater number of NAION cases. The researchers noted that excluding patients on metformin alone from the reference group was crucial to avoid overestimating the adverse effects of GLP-1 RAs, given that these individuals often have better glycemic control.

While the study provides important insights, the authors caution that certain limitations must be considered. These include reliance on diagnostic codes, the lack of precise data on the onset of type 2 diabetes before Medicare enrollment, and the restricted age range of participants, which may limit the applicability of findings to younger populations.

“Given the growing popularity of GLP-1 RAs for diabetes management and weight control, the researchers emphasize the need for further investigation into their ocular safety profile. They highlight that NAION, although rare, can result in permanent vision loss, making it essential for clinicians to weigh potential risks when prescribing these medications to older adults with type 2 diabetes,” the authors concluded.

Reference:

Fung KW, Baye F, Baik SH, McDonald CJ. GLP-1 RAs and Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Older Patients With Diabetes. JAMA Ophthalmol. Published online July 31, 2025. doi:10.1001/jamaophthalmol.2025.2299

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FDA Approves First Vagus Nerve Stimulator for Rheumatoid Arthritis

SetPoint Medical’s vagus nerve stimulator has received FDA approval for treating moderate-to-severe rheumatoid arthritis (RA) in patients who do not respond to or cannot tolerate biologics or Janus kinase inhibitors. This marks the first electrical therapy approved for RA.

The SetPoint System is a first-of-its-kind neuroimmune modulation device for the treatment of adults living with moderate-to-severe RA who are not adequately managed by-or cannot tolerate-existing advanced RA therapies, such as biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).

“The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases,” said Murthy V. Simhambhatla, Ph.D., CEO of SetPoint Medical. “We are committed to improving the health of people living with RA, and look forward to working with providers and payers to make our innovative therapy accessible to their patients. We plan to introduce the SetPoint System in targeted U.S. cities this year, followed by expansion across the country starting in early 2026.”

A Novel Therapy, Backed by Robust Clinical Research

More than 1.5 million Americans are living with RA, a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissue, leading to joint pain, bone erosion, deformity, reduced mobility, and long-term disability. There is no cure for RA, and current treatment options are often limited by poor patient adherence and dissatisfaction. Only 25% of RA patients are satisfied with their therapy, and up to 50% discontinue their prescribed therapies within two years, largely due to inadequate or diminishing outcomes or intolerance to adverse effects.

The SetPoint System is an implantable, integrated neurostimulation device designed to deliver electrical stimulation to the vagus nerve, once daily, to activate the body’s innate anti-inflammatory and immune-restorative pathways. This groundbreaking therapy has the potential to transform the care for RA sufferers by offering a treatment option without immune-compromising risks.

FDA approval is supported by the results of the 242-patient randomized, double-blind, sham-controlled, RESET-RA study, that demonstrated the SetPoint System’s safety and efficacy in patients with moderately to severely active RA who had an incomplete response or intolerance to one or more biologic or targeted synthetic DMARDS.

“This is a landmark study in the treatment and care of rheumatoid arthritis,” said John Tesser, MD, FACP, FACR, MACR, a leading rheumatologist and national rheumatology principal investigator of the RESET-RA study. “The study met its primary efficacy endpoint of ACR20 at three months, with improvements observed in ACR response rates and disease activity metrics through 12 months of follow-up. 75% of patients in the study were free of biologic or targeted synthetic DMARDs at 12 months.”

The device placement procedure and stimulation therapy were well-tolerated, with a low rate of related serious adverse events (1.7%), and no observations of malignancies, major cardiac events, or serious infections related to the SetPoint Therapy.

“The approval of the SetPoint System highlights the potential of neuroimmune modulation as a novel approach for autoimmune disease, by harnessing the body’s neural pathways to combat inflammation,” said Mark Richardson, MD, PhD, Director of Functional Neurosurgery at Massachusetts General Hospital and Professor of Neurosciences at Harvard Medical School, and national surgical principal investigator in the RESET-RA study. “After implantation during a minimally invasive outpatient procedure, the SetPoint device is programmed to automatically administer therapy on a predetermined schedule for up to 10 years, simplifying care for people living with RA.”

The SetPoint System received Breakthrough Device Designation from the FDA, a program designed for technologies that offer potentially more effective treatment or diagnosis for debilitating diseases. The company is also planning to evaluate its platform for treatment of additional autoimmune indications, including multiple sclerosis and Crohn’s disease.

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Maternal Mortality and Analgesia: The Unseen Connection of Epidurals and Postpartum Hemorrhage, study finds

Postpartum hemorrhage (PPH) remains the leading cause of maternal mortality globally, particularly affecting women with gestational hypertension due to their vulnerability to blood volume reduction. A recent retrospective cohort study analyzed the impact of epidural labor analgesia on blood loss within two hours post-delivery in this specific population, a critical period where up to 80% of total blood loss can occur.

Study Population and Methodology

The study included 1,903 participants who met the diagnostic criteria for gestational hypertension and were candidates for vaginal delivery. Data were meticulously collected from electronic medical records spanning nearly a decade. Comprehensive statistical analyses were performed using SPSS and R, encompassing both bivariate and multivariate logistic regression to explore associations with postpartum hemorrhage defined as blood loss of ≥300 mL. Results highlighted a prevalence of 16.9% of participants experiencing PPH of ≥300 mL. Multivariate logistic regression identified epidural analgesia as an independent risk factor for early postpartum hemorrhage (adjusted odds ratio (OR) = 1.30, 95% CI: 1.01–1.68, P = 0.039), alongside macrosomia and placental adhesion. In contrast, birth canal injury appeared protective against PPH. Notably, traditional risk factors such as age, BMI, and oxytocin use did not demonstrate significant associations with early blood loss. Prior studies have suggested that epidural analgesia does not increase PPH risk in non-hypertensive populations, raising questions about the unique pathophysiology associated with gestational hypertension. The mechanisms proposed include uteroplacental perfusion dysregulation due to vasospasm, which may impair uterine contractility, and potential disruptions to the vascular-coagulation pathway enhancing bleeding risk. Furthermore, the analysis reinforced previous findings where high BMI correlates with increased PPH risk. Critically, the definition of a ≥300 mL postpartum hemorrhage threshold was employed based on prior studies indicating its clinical relevance for early identification of PPH risk. However, the exclusive focus on the first two hours postpartum may overlook significant later blood loss, necessitating ongoing monitoring up to 24 hours.

Conclusions and Future Directions

The study concludes by calling for further prospective investigations to validate these findings and to optimize analgesic protocols to balance pain management with hemorrhagic risk in women with gestational hypertension, aiming to enhance maternal safety during childbirth.

Key Points

– Postpartum hemorrhage (PPH) is identified as the leading cause of maternal mortality worldwide, with heightened risk in women experiencing gestational hypertension due to susceptibility to substantial blood volume loss.

– A retrospective cohort study involving 1,903 women with gestational hypertension assessed the effect of epidural labor analgesia on blood loss within the first two hours post-delivery, a critical period for PPH occurrence. – Results showed a 16.9% prevalence of postpartum hemorrhage ≥300 mL, with multivariate logistic regression revealing that epidural analgesia (adjusted OR = 1.30, 95% CI: 1.01–1.68, P = 0.039), macrosomia, and placental adhesion were significant independent risk factors, while birth canal injury was protective.

– The investigation contradicted prior findings in non-hypertensive populations where epidural analgesia did not correlate with increased bleeding risk, suggesting a unique pathophysiological response in gestational hypertension that could affect uterine contractility and promote bleeding.

– The analysis reaffirmed that higher body mass index (BMI) is associated with increased PPH risk, accentuating the importance of considering obesity as a critical factor in monitoring bleeding risk during and after delivery.

– Recommendations emphasize the need for prospective studies to confirm these results and to refine analgesic strategies that effectively manage pain while minimizing hemorrhagic complications in patients with gestational hypertension, thereby improving maternal safety during labor.

Reference –

Weiguo Sun et al. (2025). Epidural Labor Analgesia Is A Potential Risk Factor For Increased Blood Loss Within Two Hours After Delivery In Women With Gestational Hypertension: A Retrospective Cohort Study. *BMC Pregnancy And Childbirth*, 25. https://doi.org/10.1186/s12884-025-07648-3.

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Womb lining problem identified as hidden cause of miscarriage in major UK study

Around one in six of all pregnancies are lost, mostly before 12 weeks, and each miscarriage increases the risk of another pregnancy loss. While the impact of embryo quality on miscarriage risk has been extensively studied, the endometrium (the womb lining) has largely remained a missing ‘black box’ in reproductive medicine.

In a study published today in Science Advances, researchers have uncovered a key piece of the miscarriage puzzle, tracing miscarriage risk back to a problem with the womb lining before pregnancy. This research offers a new scientific explanation as to why some women experience repeated pregnancy loss, even with healthy embryos.

“This is about identifying preventable miscarriages,” said lead author Warwick Medical School’s Dr Joanne Muter, whose work is funded by Tommy’s as part of its National Centre for Miscarriage Research. “Many women are told they’ve just had ‘bad luck’, but our findings show that the womb itself may be setting the stage for pregnancy loss, even before conception takes place.”

By analysing over 1,500 biopsies from more than 1,300 women, the team found that an essential biological process called the ‘decidual reaction’, which prepares the womb lining for pregnancy each month, often doesn’t progress properly in women with a history of miscarriage.

The endometrium’s role is to receive the embryo and support the development of the placenta throughout pregnancy. The decidual reaction transforms the womb lining into a supportive tissue for the embryo to implant. When it doesn’t fully activate or becomes dysregulated, it creates an unstable environment that, while still allowing embryos to implant, increases the risk of bleeding and early pregnancy loss.

Crucially, this isn’t random. The abnormal response in the womb lining, whether too weak or excessively strong, recurs across menstrual cycles for some women at a rate far greater than chance would predict. This suggests a consistent, measurable, and potentially preventable cause of miscarriage risk.

The research also shows that experiencing one miscarriage significantly makes it more likely that the womb lining will respond abnormally in future cycles, explaining why miscarriage often recurs.

Senior author Professor Jan Brosens, Professor of Obstetrics & Gynaecology at Warwick and UHCW NHS Trust and Scientific Director of the Tommy’s National Miscarriage Research Centre said: “It is well-established that chromosomal errors in embryos account for the rise in miscarriage rates in women older than 35 years. This study shows that each miscarriage increases the risk of an embryo implantation in an abnormal womb lining, regardless of age.

“Thus, the frequency of one of two events – abnormal embryo or abnormal decidual reaction – happening over hundreds of menstrual cycles determines the likelihood of miscarriage in each individual woman. Importantly, we now have the tools to screen for the risk of preventable miscarriage and to evaluate treatments that improve the womb lining before pregnancy.”

On the back of this research, the team has developed a diagnostic test to measure the molecular signals of a healthy or dysfunctional decidual reaction. The test is being piloted by UHCW NHS Trust at University Hospital, Coventry and has already supported the care of more than 1,000 patients.

Dr Jyotsna Vohra, Director of Research, Programmes and Impact at Tommy’s, said: “Far too often, women and birthing people who experience the trauma and devastation of recurrent miscarriage are left without answers.

“These findings from Tommy’s National Centre for Miscarriage Research pave the way not only for an explanation in some cases but more importantly for treatments that could prevent future pregnancy losses.”

One of the patients offered the new test, Holly Milikouris, says being given the opportunity to take part in the trial was life changing after she had experienced five miscarriages.

Holly’s diagnostic test revealed that her womb lining prepared poorly for pregnancy which had affected the development of her embryos. After undergoing treatment by Professor Brosens, she and her husband Chris went on to have two healthy children, three-year-old George and 17-month-old Heidi.

“My miscarriages were all ‘missed’, which means there were no symptoms to let us know there was a problem,” explained Holly, a civil servant from Cheshire. “We found out when I went for a scan and a grew to dread having scans.

“We felt lost and were beginning to accept that I might never successfully carry a pregnancy. The treatments that typically can help women who have experienced miscarriages hadn’t worked for us and each time we tried again we felt like we were rolling a dice with the baby’s life.

“Being given the opportunity to take part in this trial was life changing. For the first time the results of my biopsy were normal, and we went on to have not one, but two successful pregnancies. We will never be able to thank Professor Brosens enough and are hopeful that the results of this groundbreaking study will help many other families.”

Dr Tajnin Islam, a psychiatrist from Chester, had also experienced several failed pregnancies and felt she was running out of options with conventional methods before finding out about the clinic at University Hospital, Coventry. A test and biopsy carried out by Professor Brosens showed her womb lining also mounted a poor decidual reaction and after treatment she successfully retained a pregnancy.

Tajnin and her husband, a GP, now have a healthy 16-month-old son, Mivaan, who she describes as “a blessing.”

“I think this research and treatment is going to help a lot of women out there,” she said. “I’m over 40 and if I can have a baby then other women with my condition can also find the reason behind why they are having miscarriages and go on to have a baby. Thank you to Professor Brosens and the team.”

Current fertility diagnostics focus heavily on embryos, hormone levels, or genetic factors, often overlooking the role of the womb. This breakthrough positions the womb lining as a key player in early pregnancy health, opening new avenues for pre-conception care, personalised treatment, and emotional relief for patients who have long lived without answers.

Reference:

Joanne Muter et al. ,Stalling of the endometrial decidual reaction determines the recurrence risk of miscarriage.Sci. Adv.11,eadv1988(2025).DOI:10.1126/sciadv.adv1988.

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ChatGPT-3.5 Shows Moderate Accuracy in Medical Genetics Exam, reveals research

Researchers have found in a new study that ChatGPT-3.5 performed with moderate accuracy and stable results on a specialist medical genetics exam, indicating potential for educational support. However, its limitations in handling complex, domain-specific reasoning highlight the need for continued advancement before wider application. The study was published in Laboratory Medicine journal by Klaudia P. and colleagues.

To test the performance of ChatGPT-3.5, scientists chose 456 available questions from the Polish national specialist exam in medical laboratory genetics that are available online. The questions were classified by topic, genetic changes, diagnostic techniques, clinical case, and calculations, and by complexity (simple, complex). Each question was asked three times on ChatGPT to test not just the correctness but also the reliability of responses across multiple rounds of interaction. Statistical tests were then used to compare differences in performance by category, level of complexity, and repeatability.

Key Findings

  • Overall Accuracy: ChatGPT correctly answered 59% of the questions, statistically significant (P < 0.001).

By Category:

  • Calculation-based questions: 71% accurate

  • Genetic methods and genetic changes: ~60% accuracy

  • Clinical case–based questions: 37% accuracy

By Complexity:

  • Simple questions: 63% accurate

  • Complex questions: 43% accuracy (P = .001)

  • Consistency: The AI model had consistent performance throughout three repeated sessions (P = 0.43), which reflects reliability in output even when being asked repeatedly.

This research concluded that although ChatGPT-3.5 performs moderate accuracy and stable performance in responding to medical laboratory genetics exam questions, it lags behind in dealing with complex and clinical case–based reasoning. Consequently, its version at present may assist in education but is not yet adequate for advanced or high-stakes implementation in genetic medicine. Further advancement in AI reasoning and domain adaptation will be required before these tools can be introduced to professional medical education or practice with confidence.

Reference:

Klaudia Paruzel, Michał Ordak, Assessment of ChatGPT-3.5 performance on the medical genetics specialist exam, Laboratory Medicine, 2025;, lmaf038, https://doi.org/10.1093/labmed/lmaf038

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PRP Found Effective in Enhancing Wound Healing in Burn Patients: Study

Researchers have found in a review that Platelet-Rich Plasma (PRP) significantly improves wound healing and reduces complications such as infections in burn patients. However further research is recommended to validate these benefits and support wider clinical application.

Burn injuries cause significant mortality, morbidity, and financial and psychological burdens for patients and families. Platelet-rich plasma (PRP) has shown some benefits in burn wound healing, but its efficacy is unproven. This meta-analysis aimed to evaluate PRP’s effects on burn wounds. A comprehensive search of Scopus, PubMed, Web of Science, and Cochrane Library was conducted until January 22, 2025, for randomized controlled trials (RCTs) on PRP’s effect on burn wounds. The mean difference (MD), standardized MD (SMD), or odds ratio (OR) of the studies was calculated. Results: Nine RCTs with 413 participants were included. PRP significantly reduced wound healing time (MD: −6.68 days, 95% CI (−10.96, −2.39)), wound infection incidence (OR: 0.18, 95% CI (0.04, 0.88)), and dressing change frequency (MD: −14.50 times, 95% CI (−16.45, −12.55)). There was a significant increase in the healed area percentage in the intervention group (MD: 6.82%, 95% CI (2.58, 11.06)). However, there was no significant difference between the intervention and control groups in pain score or graft take percentage. This review shows that PRP enhances wound healing and reduces adverse events like wound infection in burn patients. Future studies should further explore PRP’s effects to support its broader clinical use.

Reference:

Yi H, Li R, Li C. Platelet-rich Plasma for the Management of Burn Wound: A Meta-Analysis. The International Journal of Lower Extremity Wounds. 2025;0(0). doi:10.1177/15347346251359067

Keywords:

PRP, Found, Effective, Enhancing, Wound, Healing, Burn Patients, Study , Yi H, Li R, Li C. Platelet-rich Plasma

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Medical Device Imports Still at 70%, India Spent Over USD 25 Billion in 5 Years: Parliament Informed

Delhi: India spent over USD 25 billion in foreign exchange on imports of electromedical equipment, including ventilators and diagnostic imaging devices, and surgical instruments between FY2020-21 and FY2024-25, the Parliament was informed.

According to data submitted by the government in the Rajya Sabha, the cumulative import value for electromedical equipment stood at USD 24,586 million and for surgical instruments at USD 951 million.

This comes in response to a query raised by Shri Narain Dass Gupta seeking details of foreign exchange outflow on imports, the vulnerabilities arising from import dependence, and policy interventions to reduce it. As per the official reply provided by Minister of State for Chemicals and Fertilizers Anupriya Patel on July 29, 2025, “as per import data maintained by the Directorate General of Commercial Intelligence and Statistics, the value of imports of electromedical equipment, including ventilators and diagnostic imaging equipment, and surgical instruments during the last five years is as under: (In million US$)

FY2020-21

FY2021-22

FY2022-23

FY2023-24

FY2024-25

Electromedical equipment (including ventilators and diagnostic imaging equipment)

3,569

5,441

4,884

5,408

5,284

Surgical instruments

104

169

210

205

263

In response to questions on India’s high import dependence, the government noted that it had assessed the situation and initiated several schemes to boost local manufacturing. “In 2020, assessing that the domestic medical devices market was heavily dependent on imports, which contributed to more than 85% of the market, Government launched the following schemes,” the reply stated.

The “PLI Scheme for Promoting Domestic Manufacturing of Medical Devices” was launched with a total budgetary outlay of Rs 3,420 crore and a five-year performance-linked incentive period from FY2022-23 to FY2026-27. Under this scheme, “selected companies are eligible for financial incentive for incremental sales of domestically manufactured medical devices… So far, 21 greenfield projects have been commissioned, and production has started for 54 products, which include high-end medical devices on which the country has been import-dependent, such as linear accelerators, MRI, Ultrasound, CT scans, Mammograms, C-Arm and X-ray machines.” Till March 2025, “cumulative eligible sales Rs 10,413.40 crore have been achieved under the scheme, including exports worth Rs 5,002 crore.”

Additionally, the “Scheme for Promotion of Medical Devices Parks” was launched to create common infrastructure and testing facilities. “Three parks have been approved and are at an advanced stage of development in Greater Noida (Uttar Pradesh), Ujjain (Madhya Pradesh) and Kanchipuram (Tamil Nadu). The total project cost of these parks is over Rs 871.11 crore, with Central assistance to the tune of Rs 100 crore each.”

Further policy actions include the announcement of the “National Medical Devices Policy, 2023” aimed at accelerating growth of the sector. Under this, several initiatives were undertaken:

“The Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) scheme has been launched with an outlay of Rs 5,000 crore… Under this, a Centre for Excellence in medical devices has been established at the National Institute of Pharmaceutical Education and Research, Ahmedabad with an outlay of Rs 100 crore.”

“The Uniform Code for Market Practices in Medical Devices, 2024 has been issued.”

“The Scheme for Strengthening Medical Device Industry has been launched with a financial outlay of Rs 500 crore to provide support in manufacturing of key components and accessories, skill development, support for clinical studies, development of common infrastructure and industry promotion.”

Despite these measures, the Minister informed the House that India’s import dependence in the sector remains high. “In November 2024, assessing that the dependence on imports continues to be about 70%, Government has launched the Scheme for Strengthening Medical Device Industry…”

In response to whether any target had been set to reduce import dependence to below 40%, the government replied: “No, Sir.”

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Indian Review Stresses Prevention Strategies, Early Referral, and Timely Liver Transplantation in Pediatric Acute Liver Failure

India: The rising incidence of Pediatric Acute Liver Failure (PALF) is a growing concern in India, with experts stressing the need for early detection, prevention, and timely referral to specialized centers. A recent review article, authored by Dr. Smita Malhotra from the Department of Pediatric Gastroenterology and Hepatology, Indraprastha Apollo Hospital, New Delhi, provides an in-depth overview of the condition, its causes, and approaches to management.

Acute liver failure in children is a medical emergency with rapid progression, often transforming a healthy child into a critically ill patient within hours or days. “Acute liver failure is a catastrophic condition. A child who is perfectly fine can deteriorate dramatically in a very short time, making timely intervention vital,” stated Dr. Smita in her conversation with Medical Dialogues. 

The review, published online in Apollo Medicine, highlights that in India, infections remain the predominant cause of PALF, with Hepatitis A virus (HAV) being the most common etiology. Unlike Western countries, where paracetamol toxicity is a leading cause, infections account for the majority of pediatric cases in developing nations. Dr. Smita emphasized that Hepatitis A is a vaccine-preventable disease, yet the vaccine is not part of the government’s universal immunization program. “We often see children progressing to liver failure simply because they were not vaccinated against Hepatitis A. Promoting this vaccination and creating awareness are critical to preventing such cases,” she noted.

The article also addresses other important etiologies, including metabolic disorders, drug or toxin-induced injuries, and, in some instances, indeterminate causes. A significant concern raised by Dr. Smita is the increasing number of cases linked to the use of alternative or herbal medications. “Certain Ayurvedic and herbal preparations can be toxic to the liver. These, along with inadvertent paracetamol overdosing, are preventable causes of acute liver failure and require public awareness,” she said.

Early diagnosis plays a pivotal role in improving outcomes. According to Dr. Smita, most peripheral centers detect PALF only when neurological symptoms such as irritability or altered consciousness appear. However, simple monitoring of coagulation parameters like INR can help diagnose the condition earlier, allowing timely referral before irreversible complications set in.

Management of PALF is complex and requires a multidisciplinary team, including pediatric hepatologists, intensivists, nephrologists, transplant surgeons, and specialized nursing support. Cerebral edema remains one of the most feared complications due to its potential to cause irreversible brain damage. Preventive strategies include early ventilation, maintaining low ammonia levels through timely dialysis, and minimizing stress or transfer with appropriate medical protocols, with a medical expert in attendance once encephalopathy sets in.

Liver transplantation continues to be the definitive treatment for severe PALF. Dr. Smita highlighted that pediatric liver transplantation in India has advanced significantly over the past two decades, with survival rates exceeding 95% in many centers. She also emphasized the importance of promoting both cadaveric and living-related donation. “There are still misconceptions about donor safety, but with proper evaluation, living donors remain safe, and the liver regenerates after partial donation, especially in pediatric cases where only a small segment is required,” she explained.

The review highlights the urgent need for awareness campaigns focusing on Hepatitis A vaccination, regulation of alternative medicines, strengthening early diagnostic capabilities in smaller centers, and expanding infrastructure for pediatric liver transplantation. As Dr. Smita summarized, “Early recognition, timely referral, and a multidisciplinary approach are the key factors that can turn the tide in saving young lives affected by acute liver failure.”

Reference:

Kaur, J., Malhotra, S., Kumar, K., & Sibal, A. Management of Acute Liver Failure in Children. Apollo Medicine. https://doi.org/10.1177/09760016241299530

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Beta-HPV can directly cause skin cancer in immunocompromised people

Researchers at the National Institutes of Health (NIH) have shown for the first time that a type of human papillomavirus (HPV) commonly found on the skin can directly cause a form of skin cancer called cutaneous squamous cell carcinoma (cSCC) when certain immune cells malfunction. cSCC is one of the most common cancers in the United States and worldwide. Previously, scientists believed HPV merely facilitated the accumulation of DNA mutations caused by ultraviolet (UV) radiation, usually the primary driver of cSCC. The findings were published today in The New England Journal of Medicine.

“This discovery could completely change how we think about the development, and consequently the treatment, of cSCC in people who have a health condition that compromises immune function,” said Andrea Lisco, M.D., Ph.D., of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “It suggests that there may be more people out there with aggressive forms of cSCC who have an underlying immune defect and could benefit from treatments targeting the immune system.”

There are many different types of HPV, each tending to infect cells in a particular tissue and part of the body. The types of HPV found mostly on the skin-beta-HPV-are considered benign members of the skin microbiome that typically do not integrate into the DNA of skin cells. This contrasts with the alpha types of HPV, known to integrate into the DNA of mucous membrane cells and directly cause cancer of the genitals, anus, head and neck.

The NIH researchers made their discovery in a 34-year-old woman who came to the NIH Clinical Center for evaluation and treatment of recurrent cSCC on her forehead. She had undergone multiple surgeries and a round of immunotherapy to try to remove or kill the tumor, but it repeatedly grew back. Her local doctors thought this was due to an inherited inability to repair DNA damaged by UV radiation plus an impairment in immune cells called T cells. The tumor was one of many progressively worsening HPV-related diseases the woman was experiencing.

Through a sophisticated genetic analysis, the NIH researchers discovered that a beta-HPV had integrated into the cellular DNA of the woman’s well-established tumor and was extensively producing viral proteins there. This contradicted the prevailing theory that beta-HPV only facilitates the establishment of cSCC without integrating into cellular DNA and plays no role in maintaining the cancer. Further genetic analysis of the woman’s cells showed they were fully capable of repairing DNA damage from UV radiation, suggesting the virus alone had caused cSCC.

To understand how beta-HPV could take the unusual steps of integrating into the woman’s skin-cell DNA and multiplying there unchecked, the investigators studied the woman’s inherited immune disorder. They found that her genetic mutations greatly hampered T cells from activating in response to skin-cell infection by beta-HPV. This suggested that the immune disorder itself was responsible for the woman’s worsening HPV-related diseases, including the beta-HPV cSCC on her forehead, and that treating this disorder might cure all of them.

Accordingly, NIH investigators developed a personalized plan to give the woman a stem cell transplant to replace her defective T cells with healthy ones. The process required extreme care because she was immunocompromised even before treatment began. The transplant proceeded without complications. Afterward, all her HPV-related diseases including the recurrent, aggressive cSCC resolved and have not recurred during the more than three years since the transplant. This confirms that the woman’s inherited disorder had prevented her T cells from keeping beta-HPV in check, allowing the virus to directly cause and sustain cSCC.

“This discovery and successful outcome would not have been possible without the combined expertise of virologists, immunologists, oncologists and transplant specialists, all working under the same roof of the NIH Clinical Center,” said Dr. Lisco.

According to the study authors, their finding suggests that other people with defective T-cell responses may also be susceptible to cancer caused directly by beta-HPV.

Reference:

Peiying Ye, Resolution of Squamous-Cell Carcinoma by Restoring T-Cell Receptor Signaling, New England Journal of Medicine, DOI: 10.1056/NEJMoa2502114.

 

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