Boston Scientific Corp. reported the controlled launch of its Acurate Neo2 aortic valve system in Europe. The next-generation transcatheter aortic valve implantation (TAVI) technology extends the clinical performance of the original Acurate Neo platform and includes an expanded indication for patients with aortic stenosis. Read More
Abbott Laboratories is celebrating another win with its continuous glucose monitoring (CGM) technology. This time, the company revealed that it has scored the CE mark for its next-generation Freestyle Libre 3 system. Wells Fargo’s Larry Biegelsen noted that the arrival of the CE mark came slightly earlier than his group had expected. Read More
The U.S. FDA’s effort to compile a guidance for prescription, point-of-care (POC) blood glucose meter (BGM) test systems seems to show that guidances can be as iterative as the devices they govern. The FDA announcement for the Sept. 28, 2020, final guidance said that the differences between the 2020 final and the 2018 draft include “a minor edit” regarding user accessibility and a technical correction for hemoglobin testing concentration, yielding a document that is finally ready for prime time after four tries over six years. Read More
KARACHI, Pakistan – Faced with lockdowns and massive disruptions to supply chains, distributors and manufacturers of surgical equipment in countries across South Asia like Pakistan, Indian, Bangladesh and Nepal are struggling to find a way forward but also looking for opportunities to expand their share of the global market while reducing their existing reliance on imports of basic supplies. Read More
PARIS – Miracor Medical SA secured a $28 million series E funding round for its Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) impulse system, intended for treating patients presenting with ST-Elevation Myocardial Infarction (STEMI). “This funding will be used to move the PiCSO clinical trial program forward, and to begin distributing our technology in Europe,” Olivier Delporte, CEO of Miracor, told BioWorld. Read More
With only days left before Inovio Pharmaceuticals Inc. planned to initiate a phase II/III trial of its COVID-19 DNA vaccine candidate, INO-4800, and its accompanying delivery device, the FDA placed a partial clinical hold on the company’s study. This is the study’s second delay as the company originally planned to begin in July or August. November is now the earliest potential start date. Inovio told BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.” Read More
Wellington Life Sciences general partner Regina Hodits, during a talk with CBT Advisors CEO Steve Dickman at the recent Biopharm America meeting, said the disaster scenario feared for European investments when COVID-19 struck “turned out very different. We never have a lot of time off in summer, not as much as we would want to, but this year we certainly had no time off,” as portfolio firms found money and Wellington tapped new opportunities. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angle, Endpoint Health, Fibrogenesis, Handsfree Health, Ibiologics, Stryker. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Masimo, Quotient, Zymo Research. Read More
Keeping you up to date on recent developments in cardiology, including: Using biomarkers to detect minor strokes; ACC, Novartis team up on heart failure; Scientists ID new abdominal aortic aneurysm genes. Read More
