The U.S. FDA has granted a breakthrough device designation for a new hemodialysis system from Fresenius Medical Care Holdings Inc. The device is designed to prevent blood blotting without the use of blood-thinning medication, such as heparin, that most dialysis patients require.
The FDA held a webinar directed toward the recent draft guidance for the accreditation scheme for conformity assessment (ASCA), but while independent labs figure to handle much of the related activity, FDA staff welcomed manufacturer's labs as well, emphasizing that the agency seeks the participation of all potentially interested parties.
The U.S. Patent and Trademark Office's (PTO) January guidance is credited with improving the patent examination process, but case law still rules the world outside the halls of the agency, a fact that suggests life science applicants draft their claims with an eye toward both the courts and the PTO.
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.