The race is on. After six years as the only FDA approved devices for left atrial appendage closure, Boston Scientific Corp.’s Watchman products face a challenger, Abbott Laboratories’ Amplatzer Amulet. With the Amulet’s FDA approval in mid-August and positive results in a head-to-head trial presented at the 2021 European Society of Cardiology Congress on Tuesday, the Watchman has reason to look over its shoulder at a competitor that could change the game entirely. The trial results were published simultaneously in Circulation. Read More
U.S. Attorney General (AG) Merrick Garland has rescinded two important policy documents, including the Brand memo, which limited the ability of federal prosecutors to use non-compliance with federal agency guidance as proof of violations of the law. The rescission of these memos increases the risk that drug and device companies will be prosecuted more vigorously due to deviation from FDA guidance documents, which at times conflict with other guidances and thus may create a series of nearly unavoidable compliance failures. Read More
The FDA has designated Impedimed Ltd.’s Sozo digital health platform a breakthrough device for renal failure, paving the way for the first FDA approved device to measure fluid volume in the dialysis setting. Read More
LONDON – Ibex Medical Analytics Ltd. has claimed a further advance in applying artificial intelligence (AI) to the interpretation of digitized pathology slides, reporting that the first commercial system in the world using AI to detect gastric cancers has gone live. The Galen Gastric system has been deployed at the pathology lab of Maccabi Healthcare Services, one of Israel’s leading HMOs, where it is now operational alongside Ibex’s breast and prostate cancer AI systems. Read More
Vuno Inc. received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for Vuno Med Deepcars, its artificial intelligence (AI) medical device for cardiac arrest prediction. Approval in hand, Seoul-based Vuno will push for wider adoption of its biosignal-based AI technology. Vuno Med Deepcars predicts the probability of cardiac arrest occurring within a 24-hour period by analyzing a patient’s pulse, respiratory rate, diastolic and systolic blood pressure as well as body temperature. The data is collected from the electronic medical record of hospitalized patients. Read More
Although COVID-19 is still dictating how things are done in the U.S. and throughout the world, the FDA looked beyond the pandemic in an update to its guidance on conducting clinical trials of medical products during the public health emergency. Read More
New hires and promotions in the med-tech industry, including: Artio Medical, Bactiguard Holding, Dante Labs, Hyperfine, Sequana Medical, Talis Biomedical. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Gala Therapeutics, Medalliance, Opko Health. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: B. Braun, Cellcarta, Inspire Medical Systems, Oxford Biodynamics, Quality Cancer Care Alliance, Shoulder Innovations. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Mirus. Read More
