Hologic Inc. moved to expand its breast surgery line with the acquisition of Endomagnetics Ltd. (Endomag) for a proposed $310 million. Endomag offers a magnetic system that allows precise localization of tumors in the breast and lymph nodes without the use of radioactive materials or wires, enabling greater preservation of healthy tissue. The transaction is expected to close in the second half of 2024. Read More
Precision medicine holds exciting promise for the medical device industry as it offers a range of solutions within diagnostics, digital devices and imaging, which could transform patient care, delegates heard at the LSX World Congress in London. However, there are a range of challenges ahead, including the population of clinical data, getting past the inertia of physicians and making it easier to run clinical studies. Read More
U.S. Medicare coverage of products for leg and foot ulcers has undergone a second review in less than a year thanks to pushback from stakeholders after the August 2023 issuance of proposed non-coverage policies for more than 100 cell and tissue-based products. Read More
It’s been a year since U.S. FDA Commissioner Robert Califf first started talking about reforming the agency’s advisory committee process. Now the FDA is moving beyond talking about it to listening. The agency has scheduled an all-day listening session June 13 to get feedback on optimizing the use of adcoms and the processes involved. Read More
Royal Philips NV has come to terms over class-action litigation in which plaintiffs alleged that particulate matter in continuous positive airway pressure (CPAP) machines has proven harmful to their health, bringing the matter to a $1.1 billion conclusion. Despite the 10-figure sum, news of the April 29 settlement sent the company’s share prices up by roughly a third in early morning trading, suggesting that investors had already baked their expectations of the settlement into their thinking about the company’s future. Read More
In what represents its first patenting, PBSF Inc. filed for protection of brain monitoring and neuroprotection strategies for infants at high risk on a large scale. Read More
New hires and promotions in the med-tech industry, including: Bio-Techne, Carestream, Highridge Medical, Livanova, Marlabs, Meddux Development, Pixelgen, Sphere Fluidics. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Mission Bio, Electrocore, Virtual Incision. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 908, Akili, Bostongene, Genomics, GSK, Laborie, Lunit, Liberate, Radiobotics, Redwave Technology, Seastar Medical, Shionogi. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeye Health, Senseonics, Route 92 Medical, Single Pass, Toku. Read More
