Garwood Medical Devices LLC's biofilm disruption device, Bioprax, has received breakthrough device designation from the U.S. FDA. Bioprax turns metal implants into electrodes and uses low-voltage electricity to eliminate the bacteria associated with biofilm infections.
Dental devices would likely strike most observers as fairly simple items, but an FDA employee said on a recent webinar that these filings have a refuse-to-accept (RTA) rate in excess of 80%, suggesting sponsors have a lot of regulatory homework to do. The FDA finalized the RTA policy for 510(k) devices in September 2019, wrapping up a draft that originated in 2012, but which is on the second iteration.
CLEVELAND – Patents took center stage on the final morning of Cleveland Clinic's Medical Innovation Summit, with two experts shedding some light on the issues surrounding patentability – particularly in light of recent legal cases and a hearing before a subcommittee of the Senate Judiciary Committee.
The U.S. FDA's draft guidance for labeling and patient information for breast implants addresses concerns over anaplastic large cell lymphoma, but the draft also recommends biennial examination via ultrasound or MRI after five years, a recommendation that could prove a boon to makers of these imaging systems.
The FDA's September 2019 final guidance for the humanitarian device exemption program brought some clarity to several issues, but device makers must still untangle the question of which tasks an institutional review board (IRB) has delegated to an appropriate local committee for a specific clinical site.
The U.S. FDA has given 510(k) clearance to the Advanced Intelligent Clear-IQ Engine (AiCE) for Canon Medical Systems USA Inc.'s Aquilion Precision CT scanner. The regulatory green light brings artificial intelligence (AI)-based image reconstruction capabilities to the world's first ultra-high resolution CT imaging system.
RSS
