Dexcom Inc. rolled out its plans for 2024 and 2025 at an Investor Day event held at the beginning of the American Diabetes Association Annual Meeting in its hometown of San Diego on June 23. The company is looking to expand from diabetes into metabolic health more broadly and previewed several new products designed to appeal to a wider market. Read More
The near $50 million cash injection Nvision Imaging Technologies GmbH recently received is “instrumental” as it will allow the company to take its hyperpolarized magnetic resonance imaging (MRI) technology to labs worldwide, CEO Sella Brosh told BioWorld. The German startup’s quantum technology makes MRI imaging up to 100,000 times more precise which will allow for the earlier diagnosis of cancer, better assessment of the risks involved and the ability to assess in a matter of days, whether treatment is working. Read More
U.S. Medicare coverage for breakthrough devices has been a hot topic for several years now, but industry is one step closer to making this policy dream a reality thanks to another new proposal from the Centers for Medicare & Medicaid Services (CMS). The agency released a new version of the Transitional Coverage for Emerging Technologies (TCET) program that seems to satisfy most of what med-tech trade associations sought, but the catch is that manufacturers must notify CMS of their intent to take part in TCET a year before the FDA will decide whether to grant market authorization to the device. Read More
The imaging and advanced guidance for workflow optimization in interventional oncology consortium (IMAGIO) consortium of clinical partners in the EU, led by Royal Philips NV, has been awarded $26 million under the Innovative Health Initiative (IHI) to carry out research into less invasive cancer therapies. Read More
The U.S. Office of Inspector General (OIG) has concluded an analysis that found fault with Medicare payments for genetic testing under CPT code 81408, a code that covers tests for a variety of mutations of medical interest. According to OIG, these claims were often paid $2,000 each despite poor oversight from Medicare administrative contractors (MACs), raising the risk that a substantial percentage of roughly $888 million in claims paid between 2018 and 2021 were either fraudulent or at best inappropriate. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Blue Earth Diagnostics, Dariohealth, Medtronic, Reflexion Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Accuray, Accyourate, Baird Medical, Betters, Cerevasc, Collplant, Escala Medical, Engineering, Femasys, Lianmedical, Prenetics, Techsomed. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medical IP. Read More
