The pandemic exponentially amplified the move to more patient-driven health care with at-home monitoring, wearable medical devices and telemedicine. Testing has arguably seen the greatest shift, led by emergency use authorizations (EUA) for dozens of rapid tests for SARS-CoV-2. Laboratory Corp. of American Holdings Inc. (Labcorp) stands to benefit even more from the trend with an EUA for an over-the-counter multiplex respiratory virus test and the launch of an at-home collection kit for testing hemoglobin A1c (HbA1c) this week.
Evotec AG and Sernova Corp. are joining forces in a bid to develop a functional cure for type 1 diabetes. The companies plan to file an IND early in 2024 for a combined cell therapy and medical device product comprising Evotec’s human beta cells, derived from the company’s induced pluripotent stem cell platform, and Sernova’s Cell Pouch delivery system, which provides transplanted cells with a vascularized, physiologically appropriate environment that enables them to secrete insulin and other hormones involved in regulating blood glucose levels.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exactech, Jointmedica, Labcorp.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Coeptis, Grail, Invo Bioscience, Medaxiom, Onesky, Optigroup, Orasure, Ortho, Quidel, Scholte Medical.
Rennes University Hospital in France has just this April completed a surgical procedure in the operating room wirelessly, thanks to the 5G network. Cardiologist Erwan Donal performed a heart operation there on a simulation manikin, monitored remotely from Athens, Greece, by heart surgeon Alexandros Stefanidis, from the department of cardiology at the General Hospital of Nikea.
Regulatory harmonization is seen as vital to the development of markets for artificial intelligence (AI) and machine learning (ML), but there is some variation in the terminology used to describe these algorithms. The International Medical Device Regulators Forum (IMDRF) has posted a document that includes some definitions for ML terms such as unsupervised machine learning, a key development if regulations across the globe are to avoid a hopeless state of balkanization.
Among the policies the U.S. FDA’s device center leveraged for testing during the COVID-19 pandemic was the long-standing enforcement discretion lever, which drew less attention than the agency’s use of emergency use authorizations (EUAs). Nonetheless, the Government Accountability Office (GAO) urged the FDA to develop a formal policy for the use of enforcement discretion for pandemic-related tests, including some metrics for when that discretion would come to an end.
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