Akura Medical’s Post

today's #cyclodextrin are about FDA Demands and Cavadex FDA directed Cholrem to remove all claims regarding the product, Cavadex, from all websites. According to current information listed on the websites Cavadex: - is NOT a drug - has no controlled clinical trial data On the other hand, also according to the websites, Cavadex: - Reduces Angina within 2-4 weeks - reduces plaques within 2-3 months - has no side-effects - has several further health benefits How do you see this issue? What would you suggest to Cholrem? #fda #cholesterol #cardiovascular #atherosclerosis

The identification and management of patients at high bleeding risk (HBR) undergoing TAVI are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI. https://lnkd.in/e6Ri8Wez

The identification and management of patients at high bleeding risk (HBR) undergoing TAVI are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI. Philippe GAROT https://ow.ly/mYNi50S3PKh

🎯 Warfarin INR Targets - Mitral Valve Replacement 🎯 Did you know that mitral valve replacement patients require a stricter INR target? Global guidelines like ACCP and NHS recommend 2.5–3.5 due to a higher risk of thrombogenesis. 💡 These small clinical details can make a big difference in patient care. 📌 Are you ready to optimize anticoagulation therapy and save lives with precision? COPYRIGHT Reserved. Healthy professional discussions and engagement are encouraged. 🔁 Follow PharmaPulse Academy for more clinical pearls, and share this with anyone who might benefit! 💊 #PharmaPulseAcademy #Warfarin #TargetINR #Pharmacists #ClinicalPharmacist #PharmacyKnowledge #PharmacySkills #ContinousEducation

Exciting News! The FDA has granted 510(k) clearance for Cohealyx™, a new collagen-based dermal matrix branded by AVITA Medical and co-developed with Regenity Biosciences. This innovative product is designed for tissue integration and revascularization to facilitate wound healing, reduce treatment timelines, and improve patient outcomes in the treatment of full-thickness wounds. $RCEL $AVH #Cohealyx #FDAApproval #WoundHealing #HealthcareInnovation #WoundCare #WoundManagement http://bit.ly/49MvX7o

“If a treatment really works, you DO NOT need a controlled trial” Now imagine your doctor tells you Drug A was tested on 100 patients, while Drug B was tested on 10,000 patients. Which one would you trust? Most would choose Drug B, assuming the larger trial means better evidence. But this logic is flawed. If Drug A showed clear results with just 100 patients, that’s compelling. Drug B, needing 1000 patients, let alone10,000 patients, to demonstrate effectiveness, raises questions. In fact, the strongest evidence for a treatment is when it works so obviously that controlled trials aren’t even necessary. You don't need a controlled trial to prove a parachute works—it’s self-evident. The reason why RCTs were introduced is to keep drugs that do not work [think Thalidomide] off the market. #rustling_feathers #FFS

GLP-1 agonists like #Ozempic and #Wegovy weren't just a 2023 trend. As we continue into 2024, the interest in these therapies show no signs of waning and it is crucial for healthcare professionals and payers to understand the current state and future of these drugs. I break down some of these latest developments in our newest publication.   Check out Goodroot and Nuwae 's latest guide update, GLP-1s: 2024 Clinical Insights, today: https://hubs.li/Q02qgqS-0

🚨 Exciting News! 🚨 Abionic has received FDA 510(k) clearance for its IVD CAPSULE PSP, a breakthrough test for the early detection of sepsis! This marks a major step forward in the fight against sepsis, a condition affecting 50M patients globally and responsible for 11M deaths each year. The IVD CAPSULE PSP, running on the abioSCOPE® platform, delivers lab-quality results from a drop of blood in just minutes—allowing clinicians to detect sepsis earlier than current standards. Early detection is critical for initiating life-saving treatments and improving patient outcomes. This FDA clearance brings Abionic’s innovative diagnostic solution to the U.S., expanding its impact on critical care. #FDAApproval #SepsisAwareness #MedicalInnovation

🦵 The US FDA has granted investigational device exemption for R3 Vascular Inc.'s MAGNITUDE drug-eluting bioresorbable scaffold, intended to treat below-the-knee (BTK) peripheral arterial disease. 💬 R3 Vascular president and CEO Christopher Owens said: “This will enable R3 Vascular to follow up on our positive first-in-human RESOLV1 study data, which demonstrated excellent and promising results with 96% patency by DUS at six months." 🔎 Learn more: https://lnkd.in/d6n5Tqb7 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dmxbUqbP #MedicalDevices #MedicalDevice #MedicalEquipment #HealthTech #GuidedSolutions #ExecutiveSearch

At RDI, we understand how complex IVD research can be. You can’t afford to worry about details falling through the cracks! We designed Diagnostica to handle the entire clinical trial process, so your trial moves from concept to market seamlessly. Get to know it now: https://lnkd.in/gv_7fmJD #IVD #Clinicalresearch #IVDTrials #ClinicalTrials