Surmodics Inc., of Eden Prairie, Minn., said the U.S. FDA has granted a breakthrough device designation to its Sundance sirolimus-coated balloon (SCB) catheter to potentially help those suffering from critical limb ischemia (CLI) and infrapopliteal arterial disease.
Los Altos, Calif.-based Heartvista Inc. has received the U.S. FDA's nod for its One Click autonomous MRI acquisition software for cardiac exams. The company said that One Click is the first artificial intelligence (AI)-assisted solution designed specifically with the goal of enhancing the performance and results of cardiac MRI scans.
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The FDA held a webinar directed toward the recent draft guidance for the accreditation scheme for conformity assessment (ASCA), but while independent labs figure to handle much of the related activity, FDA staff welcomed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.
RSS
