The U.K. government said it is taking active steps to ensure that the country’s health and social care system can reliably access safe, effective and innovative technologies. One year following its inaugural medical technology strategy, the government reported changes underway which have already transformed the med-tech sector and consequently patients’ lives. Read More
Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system . The company markets the two together as the Lumisystem to detect and resect residual breast cancer. Newton, Mass.-based Lumicell expects the Lumisystem will be available in the fourth quarter of 2024, Lumicell President and Chief Operating Officer Howard Hechler told BioWorld. Read More
Companies that buy other companies know perfectly well that they may acquire a few headaches in the process, but recent enforcement trends are making the acquiring companies more careful about acquisitions. Regulatory attorney Jennifer Bragg told an audience at this year’s meeting of the Medical Device Manufacturers Association (MDMA) that the smarter companies are doing their due diligence before approaching the target company, an exercise that could ultimately dissuade the would-be acquirer of the wisdom of the transaction. Read More
Reliance may be the regulatory buzzword of the moment, but mutual recognition agreements between regulators are much more near and dear to the hearts of device makers. Richard Phillips, director of strategy for Association of British Health Tech Industries Ltd., told an audience of device makers that the U.K. is considering recognition of devices approved and cleared by the FDA, although Phillips said such recognition for 510(k) devices might be less than a simple exercise. Read More
Crescom Co. Ltd., of Seongnam-si, Gyeonggi-do, gained domestic approval for its AI-powered software to grade knee osteoarthritis, dubbed MediAI-OA, while launching a new AI-mobile platform, Onzaram, to help manage child growth care. Read More
Researchers from the U.K. reported seeking protection for a device and method that combines electromyography (EMG) and Raman spectroscopy to improve the diagnostic pathway for patients with neuromuscular disorders, and that may be used as a minimally invasive bedside test of muscle health. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aixmed, Coreplus, GE Healthcare, GIE Medical, Glytec. Read More
