In a real-world study, Eko Health Inc.’s AI-enabled digital stethoscope dramatically increased detection rates for atrial fibrillation, heart failure and valvular heart disease in primary care settings. Researchers from Imperial College London presented results from the study at the European Society of Cardiology in Madrid. Read More
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. Read More
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. Read More
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. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bausch+Lomb, Caristo Diagnostics, Eko Health, GT Medical, Inspira. Read More
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. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Centinel Spine, Fraiya, Naitive Technologies, Qiagen. Read More
