Premarket approval by the U.S. FDA of a new venous stent system made by Medtronic plc could blast through impediments for patients who suffer from complex deep vein obstruction. Less than 1% of patients with iliofemoral venous outflow obstruction currently receive treatment, despite the risk of serious complications and sharply reduced quality of life. Approval of the Abre stent was based on a 200-patient clinical study.
The U.S. FDA draft guidance for select updates for premarket evaluation of class II atherectomy devices arrived with a lack of clarity that prompted device makers and clinicians alike to request the FDA address several sources of ambiguity. One of these is whether the agency should distinguish between particulate matter from the device vs. calcium particulates from the treated artery, while another is whether particulate evaluation is required only for devices with a coating.
Abiomed Inc. has won the U.S. FDA’s nod for its Breethe Oxy-1 device, an all-in-one, compact cardiopulmonary bypass system designed for easy mobility. The company plans a controlled release at U.S. hospitals between now and March of 2021, with widespread availability later that year.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Medtronic advises of problems with Interstim leads; Palmetto eyes coverage of CT for cerebral perfusion.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Bio-Techne, Foldax, Foundation Medicine, Helix, Kantaro, Perkinelmer, Siemens Healthineers, Theranica.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Bayer, Bioinvent, Bioxcel, Forte, Janssen, Nicox, Nitric Oxide Innovations, Passage, Santen, Sesen, Spectrum, Tracon, Y-mabs.
The latest global regulatory news, changes and updates affecting biopharma, including: MOU to help with compounding oversight; MHRA advises on MA transition; CMS delays date for radiation oncology bundle; NRC issues advisory letter to INIS.
Aidoc Inc., a provider of artificial intelligence (AI) solutions in radiology, has won U.S. FDA clearance to market the first software solution for flagging and triaging incidental pulmonary embolism (PE). The AI technology, which includes triaging and notification algorithms, is an “always on” technology that analyzes chest CT scans in real time and alerts the radiologist to any potentially abnormal findings – possibly speeding up diagnosis by hours.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Nuclear Regulatory Commission issues advisory letter to INIS; HHS authorizes pharmacy interns to test for COVID-19.