The Pi-Cardia Ltd. Shortcut — the catheter-based, leaflet modification solution for treating heart valves — received U.S. FDA clearance. The device was granted breakthrough device designation from the regulatory agency and is designed to split bioprosthetic aortic valve leaflets in patients undergoing valve-in-valve transcatheter aortic valve replacement (TAVR) procedures who are at risk of coronary obstruction.
Avicenna.ai SAS received U.S. FDA clearance for its Cina-Cspine algorithm, which uses machine learning technology to detect and triage cervical spine fractures from computed tomography images. The tool automatically flags imaging findings that are compatible with acute cervical spine fractures, which can cause serious neurological damage or paralysis.
Epitomee Ltd. happily swallowed the news of U.S. FDA clearance for its capsule for weight management, an ingestible medical device for adults who are overweight or obese. Designed for use along with diet and exercise, the capsule expands in the stomach to create a feeling of fullness that lasts up to six hours.
The U.S. FDA cleared Senseonic Holdings Inc.’s Eversense 365, the first continuous glucose monitor to last a full year with a single sensor rather than the 10 days to two weeks typical for wearable sensors such as those offered by Abbott Laboratories and Dexcom Inc.
The U.S. FDA’s draft guidance for predetermined change control protocols (PCCPs) is out for comment, but a recent agency webinar highlighted some areas of ambiguity.
Inosys Korea Co. Ltd. gained U.S. FDA 510(k) clearance for Unispace, a cervical spine cage manufactured with 3D printing technology. Unispace can be used during spinal fusion surgery, Busan-based Inosys said, wherein operators can remove a patient’s diseased or damaged disc and replace it with the cervical cage to maintain the original length of the spine.
The U.S. FDA 510(k) clearance of Airamed GmbH’s Airascore software could see millions of people benefitting from early accurate diagnosis of Alzheimer’s disease and other types of dementia. Airascore is a medical image management and processing system that uses deep learning and artificial intelligence (AI) to assess brain volumetry data on MRI scans in as little as five minutes.
The U.S. FDA’s concerns about the 510(k) program over the past decade-plus are practically the stuff of regulatory urban legend, but the agency has just unveiled a trio of draft guidances to address some of those concerns. Perhaps the most significant of these is a draft guidance for selection of a predicate device for a 510(k) filing, a document that may come across to industry as little more than an attempt to limit the devices that a manufacturer can recite in a 510(k) filing.
Imeka Solutions Inc. has received U.S. FDA 510(k) clearance for the Advanced Neuro Diagnostic Imaging system designed to provide neurologists and radiologists with vital reference information on cerebral white matter for better management of brain diseases such as Alzheimer’s. This comes on the heels of two new CPT 3 codes for quantitative brain MRI assessment which Imeka expects its clients will begin taking advantage of by January 2024.
Cathvision ApS received U.S. FDA clearance for two artificial intelligence (AI) models, the PVI Analyzer, and Signal Complexity, which are part of a suite of algorithms designed to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including atrial fibrillation. The two algorithms are part of Cathvision’s Cardialytics suite of AI-powered analytics integrated into its Ecgenius system, an electrophysiology recording system that helps with electrogram interpretation.
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