MedTech News: FDA Approvals and Launches

FDA recommends stopping SGLT2 inhibitors 3-4 days before any surgery. But should every patient be managed the same way? A new multidisciplinary consensus statement led by the SOCIETY FOR PERIOPERATIVE ASSESSMENT AND QUALITY IMPROVEMENT (SPAQI), published in the British Journal of Anesthesia and co-authored by EGDRC’s Guillermo Umpierrez, MD, provides updated recommendations for perioperative SGLT2 inhibitor management. Key takeaways:  1. Current multisociety guidelines vary significantly on when to stop SGLT2 inhibitors, how to monitor patients, and how to prevent #euglycemic #diabetic #ketoacidosis  2. The SPAQI consensus moves away from a one-size-fits-all approach, recommending tailored management based on diabetes diagnosis, comorbidities, and surgical and dietary considerations  3. Updated monitoring and prevention strategies for euglycemic diabetic ketoacidosis are included, informed by a systematic review and modified Delphi process Read the full consensus statement: https://lnkd.in/eu-hyrv6 Adriana D. Oprea  Basma Mohamed David Hepner Moises A. Deborah Richman Daniel Edmonston Costin Ionescu Mandeep Kumar BobbieJean Sweitzer Emory University Georgia Center for Diabetes Translation Research Yale School of Medicine Duke University Harvard Medical School Cleveland Clinic Lerner College of Medicine Outcomes Research Consortium Stony Brook Medicine Emory University School of Medicine Hartford HealthCare University of Connecticut Vanderbilt University Medical Center Dr. V. Mohan Diabetes Specialist Madras Diabetes Research Foundation International Diabetes Federation AIIMS (All India Institute of Medical Sciences, New Delhi)

There’s a quiet shift happening in gastroenterology that could significantly reshape how we think about motility testing. We have seen similar transitions in other fields when diagnostics became portable and affordable. Traditionally, centralized academic motility centers have relied on capital-intensive equipment like high-resolution manometry systems, fluoroscopy, and impedance setups. These infrastructures are powerful but expensive, resource-heavy, and not easily scalable. Many patients with functional GI symptoms never get proper assessment in motility labs. Now, a new wave of bionic, portable diagnostic technologies is emerging. Devices like Fecobionics and EsoTrackR are designed to assess physiological function in a patient-centered way without the need for large capital equipment or dedicated lab environments. These tools can move key diagnostics from specialized centers into everyday gastroenterology clinics, and in the future even to the homes of patients. This has several implications. The potential advantages are decentralization of care, i.e., diagnostics and biofeedback therapy move closer to the patient reducing wait times and geographic barriers, lower capital barriers where clinics may adopt motility testing without investing in expensive infrastructure, reimbursement and patients stay in the gastroenterology clinics, improved patient experience that could increase acceptance and compliance, and scalability with broader access. Clearly, there are also challenges such as how the new metrics compare to established gold standards, clinical adoption takes time and require shift in workflows, and need for training and consensus guidelines. The current trend with gastroenterology with portable and inexpensive equipment support a broader distributed ecosystem.

A Second Chance Deserves the Right Protection In the world of organ transplantation, success doesn’t end in the operating room—it truly begins there. For every transplant recipient, life after surgery is a delicate balance. At the heart of this balance lies Narrow Therapeutic Index (NTI) drugs like Tacrolimus—where even the smallest variation in drug levels can make a meaningful difference between graft survival and rejection. Tacrolimus is not just another medication. It is a lifeline. 🔹 Too little exposure may lead to rejection 🔹 Too much can increase the risk of toxicity 🔹 Even minor variability can impact long-term outcomes This is why consistency, quality, and reliability in therapy remain so critical. When we talk about giving patients a second chance at life, the shared focus is always on protecting that second chance—through thoughtful decisions and sustained care. Choosing the right quality medication is not just a clinical step—it is a commitment to: ✔️ Stability in drug exposure ✔️ Predictable outcomes ✔️ Long-term graft survival ✔️ Patient safety and confidence For transplant recipients, every dose matters. Every day matters. As healthcare professionals, our role goes beyond enabling access—we contribute to ensuring that every therapy supports precision, trust, and continuity of care. Because a second life is not only given—it is carefully protected, every single day. #TransplantCare #Tacrolimus #NTIDrugs #PatientSafety #SecondChance #HealthcareExcellence #Immunosuppression

📢 Resurge Therapeutics Reports Positive BPH iPDE Clinical Results 🔗 Read more: https://lnkd.in/gTCZaCXD Encouraging progress in men’s health and minimally invasive treatment innovation. Resurge Therapeutics has reported positive clinical results for its #iPDE technology in benign prostatic hyperplasia (#BPH), supporting advancements in urology care and procedural innovation. About the Company: • Medical technology innovator • Focused on #urology and minimally invasive care • Advancing next-generation treatment technologies Key Highlights: • Positive #iPDE clinical results reported • Advances BPH treatment innovation • Supports minimally #invasive healthcare solutions Innovative therapies for #BPH can help improve patient comfort, treatment outcomes, and quality of life for millions worldwide. 👏 Congratulations to the Resurge Therapeutics team on this progress. Mikael Trollsas, John Stankus, Shahram Shawn Gholami 🤝 “Medical innovation continues transforming the future of men’s health and urology care.” #MedTech #Urology #BPH #HealthcareInnovation #MedicalDevices #MenHealth #Diagnostics FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization World Health Organization European Medicines Agency American Urological Association European Association of Urology Society of Urologic Nurses and Associates (SUNA) Advanced Medical Technology Association Medical Device Innovation Consortium (MDIC) || cGxP.wire || cGxP.Directory || cGxP.jobs || cGxP.Tech ||

Turning light into cellular fuel -this truely should be acknowledged as a significant roleplayer in the current brain and mental health paradigm shift happening at global level

Obesity management medications for the surgeon ... and everyone else. This is a great review. Whether you are prescribing these medications or not, most clinicians are encountering #GLP1 medications in everyday practice and surgeons are definitely seeing them and need to be aware of the ins and outs of their use at all stages of care. Important points to consider: 🔹 Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and dual gut hormone therapies have transformed #obesity management, achieving weight loss approaching that of metabolic #bariatric surgery and offering broad metabolic and #cardiovascular benefits. 🔹 For surgeons, these agents are increasingly relevant across the care pathway: as preoperative optimisation tools, postoperative adjuncts for recurrent weight gain and alternatives for patients unsuitable for surgery. 🔹 Perioperative management of patients on GLP-1 RAs requires awareness of potential delayed gastric emptying and aspiration risk, but emerging evidence supports their continued use around elective surgery with appropriate precautions. 🔹 In oncology, GLP-1 RAs may have roles in cancer prevention, treatment optimisation and survivorship by addressing obesityrelated metabolic dysfunction, though prospective evidence is still emerging. ⇒ Adverse effects such as gastrointestinal symptoms, gallstones, pancreatitis and nutritional deficiencies are clinically relevant for surgical patients and must be proactively recognised and managed. 🔹 GLP-1 RAs should be viewed as complementary to surgery, expanding the multidisciplinary management of obesity and metabolic disease rather than replacing surgical interventions. https://lnkd.in/gTvSERxt BMJ Novo Nordisk Eli Lilly and Company #GLP1 #obesitycare #Mounjaro #Wegovy #tirzepatide #semaglutide

Choosing between surgery and GLP-1 therapy might influence your patient’s risk of heart failure—not just their weight. Let that sink in. We’ve been trained to think: 👉 Obesity → weight loss → better outcomes But in reality, it may not be that simple. A growing body of evidence supports a strong association between obesity and congestive heart failure (CHF). In patients with obesity and type 2 diabetes, we now have two powerful, evidence-based strategies: • Bariatric metabolic surgery (BMS) • GLP-1 receptor agonists (GLP-1RAs) Both are highly effective. Both improve metabolic health. Both reduce cardiovascular risk. But here’s the uncomfortable truth: We still don’t fully know if they protect against heart failure in the same way. And that matters. Because heart failure isn’t just another complication — it’s one of the most devastating, costly, and life-limiting outcomes we see. So the real question becomes: 👉 Is it the amount of weight loss that matters? 👉 Or the mechanism of intervention itself? BMS → profound, sustained weight loss + hormonal and metabolic changes GLP-1RAs → metabolic modulation + proven cardioprotective effects Different pathways. Potentially different outcomes. 📊 What does the evidence say? • STEP trials (semaglutide): significant and sustained weight loss with cardiometabolic improvement • LEADER trial (liraglutide): reduction in major adverse cardiovascular events (MACE) • SUSTAIN-6: cardiovascular safety and benefit of semaglutide • Observational BMS data: reduced long-term cardiovascular events and mortality Yet, direct comparative data on primary heart failure outcomes remain limited. 🔍 Clinical takeaway for physicians: Treatment selection in obesity and type 2 diabetes should extend beyond weight loss and glycemic control. Heart failure risk may be influenced by the intervention itself—not just the kilograms lost. Until robust comparative data emerge, an individualized, risk-based, patient-centered approach remains essential. In clinical practice, this is no longer theoretical—it’s a real and growing dilemma. 💬 How are you approaching this in your patients? Are you leaning more toward GLP-1RAs or surgery for high-risk individuals? #Obesity #Type2Diabetes #HeartFailure #GLP1 #BariatricSurgery #Cardiology #Endocrinology #EvidenceBasedMedicine

GLP-1s were supposed to disrupt medtech. The reality has been far more complicated. From 2019 to 2024, GLP-1 prescriptions for overweight/obese adults increased 587%+. Yet US obesity has only declined ~3% from its 2022 peak. The drugs work, but the bigger issue is that most patients don’t stay on them long enough to fundamentally change disease trajectories: • Only 63% remain on therapy after 12 months • Only 14% remain after 3 years • Real-world outcomes trail clinical trial results significantly One area is seeing disruption: Bariatric surgery. A 2025 JAMA Surgery analysis found a 46% decline in bariatric surgeries among eligible patients between 2022-2025. But outside of bariatrics, the feared collapse in medtech demand hasn’t materialized. The disruption thesis wasn’t wrong. It was premature. We broke down the numbers, adherence problem, cardiovascular implications, and what this means for medtech in our latest edition of The Numbers: https://lnkd.in/g6tcMP_U

Seeing autonomous AI officially become an ADA standard of care is huge. For a clinical solution to actually work in the real world, it has to be seamless for the staff and accessible for the patient, and that’s exactly what AEYE-DS has achieved.

𝗔𝗗𝗔 𝟮𝟬𝟮𝟲 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗼𝗳 𝗖𝗮𝗿𝗲: 𝗧𝗵𝗲 𝗢𝗳𝗳𝗶𝗰𝗶𝗮𝗹 𝗦𝗵𝗶𝗳𝘁 𝘁𝗼 𝗔𝘂𝘁𝗼𝗻𝗼𝗺𝗼𝘂𝘀 𝗔𝗜 𝗶𝗻 𝗣𝗿𝗶𝗺𝗮𝗿𝘆 𝗖𝗮𝗿𝗲 The release of the American Diabetes Association's (ADA) 2026 Standards of Care in Diabetes represents more than a clinical update; it is a structural transformation in the delivery of diabetic eye care. For years, the referral-based models for diabetic retinopathy screening have struggled to  close the care gap: the long wait time and fragmented workflows mean the vast majority of patients miss their essential annual screenings. AEYE-DS closes the diabetic eye care gap by bringing screening directly to the point of care. With the ADA guidelines now recognizing autonomous AI as a leading standard for primary care, AEYE-DS transforms vision preservation into a seamless, accessible part of every routine visit. 𝗔𝗘𝗬𝗘-𝗗𝗦: 𝗥𝗲𝗰𝗼𝗴𝗻𝗶𝘇𝗲𝗱 𝗮𝘀 𝘁𝗵𝗲 𝗡𝗲𝘄 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱 Recognized within the highest tier of clinical validation, AEYE-DS fulfills the ADA’s goal of bringing vision-saving screening to where it’s needed most, in primary care: ♦𝗣𝗼𝗿𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗨𝘀𝗮𝗯𝗶𝗹𝗶𝘁𝘆: As the only FDA-cleared AI for portable cameras and only AI that requires just 1 image per-eye for the analysis and no dilation, AEYE-DS delivers the fast, accessible, point-of-care diagnosis the 2026 ADA Standards now demand. ♦𝗜𝗺𝗺𝗲𝗱𝗶𝗮𝘁𝗲 𝗥𝗲𝘀𝘂𝗹𝘁𝘀: AEYE-DS delivers an autonomous diagnosis at the point of care, eliminating the need for physician interpretation, and ensuring patients are successfully screened and notified of their result during the same visit. ♦>𝟵𝟵% 𝗜𝗺𝗮𝗴𝗲𝗮𝗯𝗶𝗹𝗶𝘁𝘆: A superior "success rate" that ensures virtually every patient can be screened successfully before they leave the clinic. ♦𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗘𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝗰𝘆: Autonomous AI manages routine diagnostics, allowing specialists to focus on treatment while seamless EHR integration automates everything - documentation, billing, care cap closure coding and even referral triggers for the patients found positive for referable DR. ♦𝗩𝗲𝗿𝗶𝗳𝗶𝗲𝗱 𝗥𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗺𝗲𝗻𝘁: Fully reimbursable under CPT 92229, finally enabling financial viability of AI-based screening. By adopting AEYE-DS, providers can move beyond the “referral black hole” and deliver the new gold standard in vision preservation. 𝗥𝗲𝗮𝗱 𝘁𝗵𝗲 𝗳𝘂𝗹𝗹 𝗮𝗿𝘁𝗶𝗰𝗹𝗲 𝘁𝗼 𝘀𝗲𝗲 𝗵𝗼𝘄 𝗔𝗜 𝘀𝗰𝗿𝗲𝗲𝗻𝗶𝗻𝗴 𝗶𝘀 𝗿𝗲𝗱𝗲𝗳𝗶𝗻𝗶𝗻𝗴 𝗱𝗶𝗮𝗯𝗲𝘁𝗶𝗰 𝗲𝘆𝗲 𝗰𝗮𝗿𝗲: https://lnkd.in/dDEsg9gc