While Europe’s biotech sector continues to face headwinds, med tech appears to be weathering the storm more effectively. Uncertainty in the U.S., heightened competition from China and a persistent lack of capital are all impacting the investment landscape, delegates heard at the LSX Investival Showcase in London. Read More
The Medicare Wasteful and Inappropriate Service Reduction (WISeR) proposal is designed to tamp down on waste, fraud and abuse in the Medicare program, but Jeff Wurzberg, a partner at Norton Rose Fulbright LLP, told BioWorld that the contractors developing these AI models have incentives to return non-covered determinations for services. Read More
Over a span of five-and-a-half months this year, 3.5% of the more than 11,000 clinical trials funded by the U.S. NIH had their grants terminated, according to an article published in the Nov. 17 JAMA Internal Medicine. That’s 383 trials that lost funding. Read More
A rapid diagnostic test from Ocean Dx SAS delivered gold standard performance in a clinical evaluation that points to a potential shift in how sepsis is identified and treated. The assay, which detects more than 1,000 bacterial species directly from whole blood, returned 100% sensitivity and 100% specificity compared with reference blood cultures, with results reported in five hours. Further, the test tripled the number of infections identified. Read More
Exactech Inc., of Gainesville, Fla., decided it will not subject itself to a 10-year corporate integrity agreement with the Office of Inspector General, an understandable move given that the company no longer intends to do business in the U.S. under its old brand. Read More
About a month after rolling out positive phase I/II data with its candidate for metastatic, castrate-resistant prostate cancer (mCRPC), Halda Therapeutics Inc. disclosed the plan by Johnson & Johnson (J&J), which is paying to take over the company for $3.05 billion in cash. Read More
Editor Annette Boyle discusses the challenges med-tech companies face in bringing innovation to market and how the industry can overcome them. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apple, Brainsway, Caranx, Cardiovalve, GE Healthcare, GTCR, ITM, Labcorp, Lunit, Masimo, Naveris, Positron, Surmodics, Venus Medtech. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Onward Medical. Read More
