It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bluewind Medical, Nemaura Medical, Icad.
Fractyl Health Inc. reported clinical updates on the Revita real world registry in Germany which has demonstrated clinical remission from type 2 diabetes (T2D) employing a device that resurfaces the duodenal mucosa, the innermost layer of the first portion of the small intestine, and a potential root cause of T2D.
Hypertrophic cardiomyopathy (HCM) might not be the talk of the town in the world of cardiology medical devices, but the condition has a devastating effect on a large number of lives, particularly in the case of early disease onset. San Francisco-based Viz.ai Inc. has won a de novo from the U.S. FDA for its algorithm for identification of patients at risk of HCM, the aptly named Viz HCM, a product the company believes will not only save lives but may save the U.S. health care system a large amount of money as well.
The $31.4 million investment Capstan Medical Inc. recently received in its Series B funding round will allow the company to make headway in its efforts to use a catheter-based, robotic delivery platform to treat patients with mitral and tricuspid valve disease. With heart disease a leading cause of death globally and cardiac procedures remaining highly invasive and filled with complications, Capstan is working to provide patients with safer, less invasive alternative.
Bruker Corp. signed a definitive agreement to acquire functional cell biology company Phenomex for $108 million as part of its Project Accelerate 2.0 strategy, which increases focus on the company’s emerging proteomics and spatial biology business. Bruker offered $1 per share, a 150% premium over the 40 cents per share closing price of Phenomex stock on Aug. 16. The all-cash transaction is slated to close in the fourth quarter of 2023.
Neckepur SAS signed a licensing agreement with Assistance Publique-Hôpitaux de Paris (AP-HP) to develop an in vitro diagnostic technology to optimize the medical devices used in extracorporeal circulation. The agreement covers the rights to use a patent for a method of evaluating and optimizing the doses of drugs administered to patients admitted to the intensive care unit (ICU) who are undergoing treatment with devices such as hemofiltration, extracorporeal membrane oxygenation (ECMO), continuous hemodiafiltration, and adsorbent column circuits.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angiodynamics, Cathvision, Tampro, Welldoc.
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