Data from the transcatheter valve and vessel trial showed that percutaneous interventions in patients with aortic stenosis and coronary disease resulted in significantly lower mortality rates than those receiving surgical treatment. Read More
Two-year data from Elixir Medical Corp.’s Bioadaptor randomized controlled trial showed that there is a significant clinical advantage in using its Dynamx coronary drug-eluting bioadaptor system over Medtronic plc’s Resolute Onyx drug-eluting stent in patients with coronary artery disease. Read More
Profound Medical Corp. received U.S. FDA 510(k) clearance for its second transurethral ultrasound ablation (TULSA) module using artificial intelligence. When used with Profound’s TULSA-Pro system, the Contouring assistant helps physicians more quickly and accurately segment prostate imaging and design treatments. Read More
The FDA’s Jeff Shuren appeared on a May 14 webinar to discuss operations at the Center for Devices and Radiological Health (CDRH), but he had some choice words for what he suggested is a widespread do-more-with-less mentality. Shuren said that expectations of CDRH’s capacity are in defiance of what he suggested is a modest volume of revenues the center receives each year, a predicament he said demonstrates that “a lot of people are running around stupid” about the realities at the FDA’s device center. Read More
The U.S. FDA issued a May 9 warning letter to Cue Health Inc., of San Diego, following what may have been a routine inspection, but the inspection disclosed that the company had made changes to a COVID test that was granted market access via the emergency use authorization program. Read More
A pair of co-published filings from Naples, Fla.-based Aerwave Medical Inc. describe apparatus and ultrasound-based methods for bronchial denervation, ablating smooth muscle or goblet cells, and emphysematous tissue remodeling in the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ascensia Diabetes Care, CB Medical, GE Healthcare Technologies, Medis Medical Imaging Systems, Nanovibronix, Optiscan Imaging, Paindrainer, Realheart, Reveal Genomic, Senseonics, Valcare Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Meditrina, Owlet, Profound. Read More
The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here. Read More
