The FDA has lifted all the clinical holds it placed on seladelpar from Cymabay Therapeutics Inc. for INDs in nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC) and primary sclerosing cholangitis, giving the company new hope.
PERTH, Australia – The U.S. FDA gave the thumbs up to Australia’s Micro-X Ltd. for its Rover mobile X-ray system. The 510(k) application was cleared in just five weeks. The concept for the Rover was originally developed under a contract with the Australian Department of Defense to prove that Micro-X’s technology could fulfill an unmet need for a full performance, digital medical X-ray imager that was light enough to be used in deployed medical facilities.
The FDA has approved Xywav (calcium, magnesium, potassium and sodium oxybates; JZP-258), an oxybate product for treating both cataplexy and excessive daytime sleepiness in narcolepsy patients ages 7 and older, from Jazz Pharmaceuticals plc.
Interludes of classical music. Little kids talking in the background. Unmuted mics as panelists multitask. Gurgles of “underwater” sound. Periods of silence as speakers forget to unmute. And then the technical problems – lots of them. Such are the challenges of addressing a virtual FDA advisory committee in the time of COVID-19.
The U.S. FDA has put a considerable amount of emphasis on patient perspectives regarding medical devices in recent years, the subject of a recent webinar hosted by the Medical Device Innovation Consortium (MDIC). One of the speakers on the webinar, Carrie Kuehn, of Evidation Health of San Mateo, Calif., said that not only do device makers have a trove of valuable data at their fingertips with patient preference data, but also that the FDA’s message is, “if patients say something, we want to hear about it.”
The U.S. FDA announced July 18 that it has granted an emergency use authorization (EUA) to Quest Diagnostics Inc. for the company’s real-time, reverse transcriptase polymerase chain reaction test for the SARS-CoV-2 virus in a development that FDA commissioner Stephen Hahn described as “an important step forward.”
The U.S. FDA has given the green light to Xact Robotics Ltd. for its Xact Ace robotic system for computer tomography (CT)-guided percutaneous procedures. The company plans to roll out the system later this year with an initial focus on interventional radiologists.
The U.S. FDA’s interest in harmonizing its regulations for medical devices with an international standard is a matter of record, but the agency has found this to be an enormously complicated task. Kim Trautman, executive vice president for medical device services at NSF International, of Ann Arbor, Mich., told BioWorld that the task of rewriting Part 820 to meet ISO 13485 in the middle is no mean feat, but also that it may be delayed again, this time because of the COVID-19 pandemic.
The next phase of testing for the COVID-19 pandemic will hopefully include the roll-out of tests for neutralizing antibodies for the SARS-CoV-2 virus, but there are some roadblocks. The FDA’s Tim Stenzel said the agency has a limited amount of information to offer regarding emergency use authorizations for these tests, a predicament that might not resolve until several applicants are in and the agency can see some information that will aid in development of performance and validation standards.
Edwards Lifesciences Corp. has scored an approval from the U.S. FDA for the Konect Resilia aortic valved conduit, a ready-to-implant solution for bio-Bentall procedures.
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