TORONTO – An airway clearance device that uses acoustic sound waves to treat lung disorders and respiratory infections like cystic fibrosis (CF) is now being used to clear the lungs of patients suffering very badly from COVID-19. Developed by Montreal-based Dymedso Inc., more than 675 Frequencer acoustic devices currently being utilized across the world are assisting COVID-19 patients by removing mucous and secretions from their lungs and smaller airways.
Miach Orthopaedics Inc. got a leg up on competitors with the U.S. FDA's de novo approval of its Bridge-Enhanced ACL Repair (BEAR) implant. The company achieved a long-term goal in orthopedics, developing a graft-free system that enables the anterior cruciate ligament (ACL) to repair itself. The device represents the first new treatment for ACL tears in three decades.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acell, Artms, Medtronic, Products + Features, Quidel, Rapid Medical.
The U.S. FDA has granted emergency use authorization (EUA) for thousands of products for the COVID-19 pandemic, and the agency is legally required to advise companies of their post-pandemic options for new marketing authorization. Conversely, companies that fail to deal with inventory for expired EUAs may find themselves in the crosshairs of the FDA, whistleblowers, and federal and state attorneys, suggesting that manufacturers of devices should have a plan for dealing with unused inventories once the public health emergency comes to an end.
After nearly three months of the U.S. federal government operating on stopgap spending measures, Congress has agreed to a $1.4 trillion spending bill for fiscal 2021. The omnibus package, which includes $97 billion for the Department of Health and Human Services, gives both the FDA and NIH small increases in funding.