Regulatory and reimbursement challenges in Europe are leading an ever-increasing number of med tech companies to prioritize the U.S. market for the launch of their devices. However, certain technologies can reach European patients more quickly, presenting valuable opportunities with the EU, delegates heard at the LSI Europe ’25 conference in London this week.
Health Canada posted a report on reduction of red tape, which includes a proposal for mutual recognition of other regulators’ inspections of device and drug manufacturing facilities.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bausch+Lomb, Caristo Diagnostics, Eko Health, GT Medical, Inspira.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biodesix, Bioaffinity, Datasea, Dnanexus, Fujifilm, Guardant, Ignite, Lunit, Masimo, Mendaera, Personalis, Royal Philips.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Centinel Spine, Fraiya, Naitive Technologies, Qiagen.
It took a memo from the president for the U.S. FDA to begin reining in direct-to-consumer prescription drug advertising with its feel-good messaging and hurried recitation of a few serious adverse events.
Exact Sciences Corp. rolled out its multi-cancer early detection test nationwide to expand screening and identify malignancies when treatment has the greatest chance of being curative. Cancerguard can detect signals for cancers accounting for more than 80% of all cancer diagnoses in the U.S. each year.
Physician ownership of medical device manufacturers can be tricky stuff where the Anti-Kickback Statute is concerned, but the Office of Inspector General recently declared it had no problem with one such arrangement due to the physician’s ratio of ownership of the company.
RSS
