Rhythm Diagnostic Systems SA received CE mark approval from EU authorities for Multisense, a wearable device that continuously monitors patients remotely. The company looks to market the device first in France and Germany. Read More
While members of the U.S. FDA’s Imaging Drugs Advisory Committee weren’t blown away March 5 by the trial performance of Lumicell Inc.’s Lumisight (pegulicianine) in helping breast cancer patients avoid second surgeries due to negative margins following a lumpectomy, they voted 16-2, with one abstention, that the benefits of the imaging drug outweigh its risks, even though those benefits are incremental. Read More
In a move to build up its dominance in the radiopharma market, Telix Pharmaceuticals Ltd. said it plans to acquire radioisotope production technology firm Artms Inc. and its advanced cyclotron-based isotope production platform, manufacturing plant and stockpile of ultra-pure rare metals. Read More
Three U.S. federal government agencies announced that their focus on consolidation in health care markets may soon ramp up, given concerns that consolidation may be affecting the cost and quality of patient care. Read More
Medtronic plc and Irvine, Calif.-based Axonics Inc. have been locked in a struggle over several patents in the past few years, but now Medtronic has shifted some of its effort from the U.S. courts to the executive branch. Read More
Discover a wealth of industry insights with BioWorld’s extensive collection of infographics, covering the latest trends and developments in both biopharma and med-tech. Our weekly infographics are curated to provide concise summaries of key topics: financings (IPOs, private financings, public/other and follow-on offerings), deals and M&As (top deals, and monthly value and volume), regulatory (including U.S. FDA and worldwide approvals), clinical trials and more. In addition, you’ll find access to BioWorld’s year-in-review reports, as well as special infographics about obesity, pain and addiction, biosimilars and the aging space. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Cooling, Attune Medical, Axena, Baxter, CND Life Sciences, Davita, Haemonetics, Irhythm, Livanova, Ondine Biomedical, QT Imaging, Springbok Analytics, Stimlabs, Tandem, Visiopharm Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Analog Devices, Cleerly, Rhythm Diagnostic Systems. Read More