Draeger Inc., of Telford, Pa., reported a recall of several lines of positive airway pressure (PAP) and other ventilation products in connection with problems seen in the adhesive used on breathing circuit components. Draeger said it has no reports of adverse events in connection with separation of the affected components during ventilation processes but has completed its testing of the corrective action and is working to replace the affected devices.
Largely underserved pediatric surgery patients in the U.S. could benefit from a new digital laparoscopic surgery solution said its developer Asensus Surgical Inc. Granted a pediatric indication by the U.S. FDA for the Senhance system in late March, the company plans to enter a market that has been largely ignored because of the difficulty performing digital laparoscopic surgery on smaller body patients.
Sanofi SA’s antitrust challenge of Mylan Inc.’s “exclusionary conduct” in the epinephrine auto-injector market met the end of the road April 17 when the U.S. Supreme Court denied cert.
The latest U.S. FDA emergency use authorizations to fall by the wayside, as COVID-19 continues to evolve, are the ones for the first Moderna Inc. and Pfizer Inc.-Biontech SE’s mRNA vaccines.
The U.S. FDA has cleared Aroa Biosurgery Ltd.’s 510(k) for its Enivo pump and catheter, which are key components of the company’s new Enivo tissue apposition platform. The device applies negative pressure to a surgical site, helping to reduce fluid accumulation following surgery. It has been cleared for use in removing surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.
Abbott Laboratories Inc. landed U.S. FDA clearance for its Freestyle Libre 3 integrated continuous glucose monitoring system (CGM)’s reader device a bit earlier than expected. With the regulatory greenlight for the durable medical equipment component received, the company is now pursuing coverage by the CMS for the entire Freestyle Libre 3 system. The system’s sensor received FDA clearance in May 2022.
Motus GI Holdings Inc. undertook further lifesaving measures to survive into 2024 as it continues to seek strategic and financial alternatives that will enable the company to accelerate commercialization of its Pure-Vu endoscopy system. CEO Tim Moran became chairman of the board as former CEO—and current President, Chief Operating Officer and director—Mark Pomeranz added the CEO position to his portfolio.
Phenomix Sciences Inc. has launched a first-of-its-kind test that could provide precision medicine treatment options for patients suffering from a particular form of obesity. Key to the saliva-based Hungry Gut test for patients still hungry after eating is the science of phenotyping enabling specialists to determine genetic sources for this and other distinct obesity conditions.
Viewray Inc., the manufacturer of the Mridian MR-guided radiation therapy system, released disappointing preliminary first quarter 2023 results and shareholders braced for more bad news as the company reported it engaged Goldman Sachs to evaluate strategic alternatives including corporate sale, merger or business combination.
Danco Laboratories LLC’s abortion pill, Mifeprex (mifepristone), and a generic will remain on the U.S. market with tighter restrictions while a challenge to the drug’s 2000 accelerated approval and the FDA’s subsequent loosening of prescribing requirements plays out on appeal. That is unless the Supreme Court says otherwise.
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