Ethylene oxide (EtO) has been a mainstay in medical device sterilization for decades, but fears of carcinogenicity sparked protests outside EtO sterilization plants in Georgia and Illinois in 2018. While the COVID-19 pandemic overrode those concerns for two years, the FDA has opened a pilot program for conversion of sterilization methods that would require fewer regulatory filings than would otherwise be the case.
Device makers do not engage in direct-to-consumer advertisement at the same pace as drug makers, but advertising and promotions are still a minefield of potential enforcement action for the unwary manufacturer. According to Jesse Atkins and Nate Downing of Gardner Law in Stillwater, Minn., even a minor skirmish with the FDA can result in an extensive review of standard operating procedures, a potentially expensive and time-consuming distraction from companies fighting for market share in the hotly contested U.S. market.
The U.S. FDA has granted de novo approval for Bonesupport AB’s Cerament G, an antibiotic-eluting bone graft designed to osteomyelitis. The company plans to launch in the U.S. in late September or early October.
In the last week, the U.S. FDA has taken two steps to expand treatment options for the millions of patients with fibromyalgia who find little relief from the three approved drugs for the condition. Neurometrix Inc. reported that the agency granted de novo authorization to its Quell device Thursday and Remedee Labs SA announced it received breakthrough device designation for its endorphin stimulation system May 12.
Hologic Inc. received FDA premarket approval for its Aptima CMV Quant assay, which enables monitoring of viral loads of transplant patients with cytomegalovirus (CMV). While CMV typically poses little risk to adults with healthy immune systems, it can cause organ rejection and death in transplant patients if untreated. The assay gained a CE mark in June 2021.
Among the policies the U.S. FDA’s device center leveraged for testing during the COVID-19 pandemic was the long-standing enforcement discretion lever, which drew less attention than the agency’s use of emergency use authorizations (EUAs). Nonetheless, the Government Accountability Office (GAO) urged the FDA to develop a formal policy for the use of enforcement discretion for pandemic-related tests, including some metrics for when that discretion would come to an end.
Medtronic plc received FDA premarket approval for its Onyx Frontier drug-eluting stent, an update to the company’s Resolute Onyx stent. The Frontier is designed for treatment of patients with coronary artery disease (CAD), a leading cause of death in the U.S. Medtronic expects the stent to receive CE mark shortly.
UCB SA’s share price slumped after the U.S. FDA rejected the pharma’s filing for psoriasis drug Bimzelx (bimekizumab), citing issues with “inspection observations” that must be resolved before approval. Shares in Brussels-based UCB (Brussels:UCB) fell 13.6% following the announcement that the FDA had rejected Bimzelx for treatment of adults with moderate to severe plaque psoriasis.
The Embold fibered detachable coil developed by Boston Scientific Corp. to obstruct or reduce the rate of blood flow during therapeutic treatment in the peripheral vasculature, has won U.S. FDA 510(k) clearance.
Wysa Ltd.’s artificial intelligence-based digital therapy received FDA breakthrough device designation for adults with chronic musculoskeletal pain, depression and anxiety. The device delivers cognitive behavioral therapy (CBT) via a digital companion or conversational agent on a smartphone.
