The U.S. FDA reported a class I recall for a single lot of the Safestar 55 breathing filter system by Draeger Inc., due to partial obstruction of the filter, which can lead to hypoxia. The affected units were part of a lot that was to be destroyed, but were instead inadvertently distributed even though they were identified as unusable after a manual inspection process at Draeger.
Artificial intelligence (AI) and machine learning (ML) present regulators and payers alike with some interesting dilemmas, but that statement can be applied to patent offices and inventors as well. In this fifth installment in a series on AI in radiology, we’ll examine the hazards of acquiring and sustaining intellectual property protection for these algorithms, a much more complicated and complex undertaking than many developers might appreciate.
A new large-scale study has found combining artificial intelligence (AI) and radiologists to analyze breast cancer screenings can lead to better patient outcomes, when compared with unaided radiologists and the use of AI alone. The study, published in The Lancet Digital Health, evaluated the performance of an AI decision referral system developed by Vara (MX Healthcare GmbH).
The U.S. FDA gave Envoy Medical Corp. the thumbs up to conduct an early feasibility study of its Acclaim cochlear implant. The fully implanted system, which earned a breakthrough device designation from the FDA, aims to be the first cochlear implant to address hearing loss without the use of any external components.
A presentation at the American Society of Clinical Oncology (ASCO) 2022 annual conference demonstrated that the Dxcover Cancer Liquid Biopsy differentiated between patients with cancer and healthy controls and detected more than 90% of stage I malignancies across a broad range of cancers. Dxcover Ltd. provided more details on its new approach to the search for reliable, rapid screening for multiple malignancies at the 12th International Conference on Clinical Spectroscopy on June 21.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carthera, Medtronic, Nucleix, Oxfordvr, Pictor.
China’s National Medical Products Administration (NMPA) approved Ocumension Therapeutics Ltd.’s and Eyepoint Pharmaceuticals Inc.’s drug-device combination product, Yutiq (fluocinolone acetonide intravitreal implant), for chronic non-infectious uveitis affecting the posterior segment of the eye.
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