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MedTech News & Updates: HR Pharmaceuticals, Inc. Received Exclusive Commercialization Rights to Poiesis Medical, LLC’s Dual Balloon Catheter Technology in North America. Enovis Completed the Acquisition of Lima Corporate.  AnX Robotica Corp Announced FDA Clearance for ProScan™: A Groundbreaking AI-Assisted Reading Tool for Small Bowel Video Capsule Endoscopy. CGBIO’s ‘NOVOSIS PUTTY’ Received FDA ‘Breakthrough Device Designation,’ Accelerate Entry into the US Market. EndoSound® Received 510(k) Clearance for Breakthrough EVS® Innovation, a Novel Endoscopic Ultrasound (EUS) Technology. Boston Scientific Initiated AVANT GUARD Clinical Trial to Evaluate FARAPULSE™ Pulsed Field Ablation System as First-Line Treatment for Persistent Atrial Fibrillation. Get a more detailed analysis, at: https://lnkd.in/gbUHy2VD #lifesciences #pharmaceuticals #marketresearch #marketanalysis #healthcare #markettrends #health #medical #news #healthcarenews #medtech #medtechnews

FDA Grants Approval to Eylea HD 8 mg Injection for Wet AMD, DME, and Diabetic Retinopathy Treatment Regeneron Pharmaceuticals' groundbreaking Eylea HD (aflibercept) Injection 8 mg gained FDA approval for wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR), offering hope with novel dosing. Initial 4-week doses shift to 8-16 weeks for wAMD/DME, 8-12 weeks for DR. PULSAR and PHOTON trials showed Eylea HD's non-inferiority to 2 mg variant in vision gains, with 12-16 week intervals. Collaboration with Bayer AG expands global impact. European and Japanese regulatory evaluations are ongoing. Trials demonstrated adaptability, highlighting advancements in eye care. Excitement mounts for further progress in enhanced treatments. For more in-depth coverage of this groundbreaking development, visit Pharmtales, your source for the Latest Pharma News. #pharma #pharmaceutical #pharmtales #latestnews #pharmanews #pharmaceuticalindustry #fda #fdaapproval #eylea #injection https://lnkd.in/d6d-zV67

𝐅𝐨𝐫 400,000 𝐰𝐨𝐦𝐞𝐧 𝐰𝐨𝐫𝐥𝐝𝐰𝐢𝐝𝐞, 𝐡𝐨𝐩𝐞 𝐭𝐮𝐫𝐧𝐞𝐝 𝐭𝐨 𝐡𝐨𝐫𝐫𝐨𝐫 𝐰𝐢𝐭𝐡 𝐏𝐨𝐥𝐲 𝐈𝐦𝐩𝐥𝐚𝐧𝐭 𝐏𝐫𝐨𝐭𝐡è𝐬𝐞 (𝐏𝐈𝐏) 𝐛𝐫𝐞𝐚𝐬𝐭 𝐢𝐦𝐩𝐥𝐚𝐧𝐭𝐬. Imagine facing a life-altering decision: surgery after breast cancer or cosmetic enhancement for confidence. This incident is a disregard for safety in pursuit of profit. The PIP scandal highlights the crucial need for stringent medical device regulation, exemplified by the Medical Device Regulation (2017/745). This crisis exposed the consequences of lax oversight in the industry. Check the Comments Section to Read the Complete Article ⬇  #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing

AM-Pharma B.V. has initiated Phase 2 clinical trials for its patented alkaline phosphatase, ilofotase alfa, as a preventive therapy for cardiac surgery-related renal damage (CSA-RD). This synthetic alkaline phosphatase has shown stability and high activity in various clinical trials. CSA-RD is a significant surgical complication for which there is currently no specific pharmaceutical treatment. #AMPharma #clinicaltrials #RenalDamage #cardiacsurgery #healthcare #lifesciences

This week's newsletter is here! Today's issue includes actions that the UK government is taking to tackle potential bias in the design and use of medical devices, new measures proposed by the European Commission for better lifecycle management of medicine authorisations and regulatory updates. https://lnkd.in/eHXbajBQ To receive our weekly newsletter directly to your inbox, just send an email to info@towermains.com with the subject “Weekly Newsletter Please”. #medicaldevices #regulatoryupdates #MHRA #pharmaceutical #drugdevelopment

Vertex’s pain drug succeeds in late-stage studies, marking major breakthrough in search for new, non-opioid medicines >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #pharma #healthcare #pharmaceutical #biotech

Exploring the Efficacy of Various Debridement Methods in Surgical Wound Healing A review of six studies on surgical wound debridement techniques found mixed results. Dextranomer beads or paste were not superior to other treatments, and enzymatic debridement had no significant advantage over saline dressings. Endoscopic surgical debridement may reduce healing time compared to open surgical methods. However, the overall evidence is uncertain due to bias and methodological limitations in the studies. More research is needed to establish definitive conclusions and improve patient outcomes in surgical wound management. For more details please click the link! https://lnkd.in/dXeNkt8m #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Uni-Bio Science Group is pleased to announce its annual results for the year ended 31 December 2023 (the “Year”). During the Year, the Group achieved record-breaking revenue, witnessing a 10.1% year-on-year (“YoY”) increase to approximately HK$484.7 million. Sales of Pinup ® and GeneTime ® performed well, registered an increase of 15.0% YoY and 9.54% YoY respectively. Profit for the year experienced a remarkable 84.04% YoY surge, reaching approximately HK$70.9 million, attributed to the Group's diligent cost control measures.  The marketing application of the Group’ s Bogutai® (teriparatide injection) was approved by the China National Medical Products Administration (“NMPA”), marking a significant breakthrough for the Group in orthopedic disease treatment and providing patients with expanded options. The NMPA’s acceptance of the marketing application for Diquafosol Sodium eye drops on 23 January 2024 marks a pivotal step towards its anticipated market approval in the first quarter of 2025.  The Group has reached a significant milestone with the successful introduction of Skbrella™ FN and plans to officially launch a self-owned medical aesthetic brand utilizing Skbrella™ FN in 2024. For more information, please follow the link to the full press release. https://lnkd.in/gWx7hcDJ #annualreport2023 #milestone

Knee Replacement Treatment: Globus Medical's Technologies Secure FDA Clearance The FDA has granted 510(k) clearance to Globus Medical’s ExcelsiusFlex with Total Knee Arthroplasty application and the ACTIFY 3D Total Knee System, marking a significant advancement in knee replacement treatment. The ACTIFY 3D Total Knee System, featuring cementless fixation and a porous lattice interface, supports both manual and robotic-assisted workflows, ensuring operative efficiency and anatomical fit. ExcelsiusFlex enhances surgical precision through robotically guided resections based on pre-planned implant placements. Daniel Scavilla, president and CEO of Globus Medical, highlighted the potential of these technologies to revolutionize knee replacement surgeries by improving precision, efficiency, and patient outcomes. For more details please click the link! https://lnkd.in/gwKprADg #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Vertex’s pain drug succeeds in late-stage studies, marking major breakthrough in search for new, non-opioid medicines >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #healthcare #productmarketing #pharma #pharmaceutical