Cosmo Artificial Intelligence Ltd. received the FDA’s nod for its GI Genius intelligent endoscopy system. The device – the first of its kind, according to the agency – uses artificial intelligence (AI)-based on machine learning to improve the detection of lesions during colonoscopy. It will be rolled out in the U.S. by Medtronic plc, which has exclusive worldwide distribution rights.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Medtronic recalls electrophysiology units over battery depletion; ASCA labs listed by FDA.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cosmo, Lucira Health, Masimo, Medtronic, Myhomedoc, Thermo Fisher Scientific.
The authors of a recent journal article see problems with the FDA’s approach to premarket review of artificial intelligence (AI) algorithms, including an undue reliance on single-site algorithm development. Regulatory attorney Brad Thompson told BioWorld, however, that hospital administrators want algorithms that maximize accuracy for their populations and are not averse to in-house development of just such an algorithm, thus creating a source of tension between what hospitals want and what the FDA expects.
HONG KONG – Coreline Soft Co. Ltd. has taken its first step into the Greater China market after receiving approval from Taiwan’s Food and Drug Administration (TFDA) on April 8 for its Aview suite of artificial intelligence (AI) medical solutions.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS, DOJ officials highlight pandemic response needs; FDA says plenty of respirators available; NICE supports use of Danis for variceal hemorrhage.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Activ Surgical.
A threat is currently hanging over the Swiss medical device industry, which is heavily reliant on trade with the EU. Upcoming changes to the CE marking regime will have the effect of making the mutual recognition agreement (MRA) obsolete. This currently allows Switzerland to enjoy unrestricted access to the medical device market in the 27 member states. Up until now, this bilateral agreement has regulated trade between Switzerland and the EU.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FCC says no need to revisit telehealth grants; NICE updates sphere usage for hepatocellular carcinoma; Health Canada: Docs, nurses not needed for workplace testing.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Crown Aesthetics, Donisi, Eyeyon Medical.
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