Product liability is always a point of concern for manufacturers of medical devices and other U.S. FDA-regulated products, and the broad contours of product liability jurisprudence are well known by corporate counsel. However, artificial intelligence products are rapidly pressing their way into routine clinical use, representing a technological shift that may occasionally deviate from the existing rules of the road where product liability is concerned.
The U.S. CMS said its Medicare administrative contractors withdrew a draft local coverage determination that would have restricted the use of surveillance testing for allograft rejection.
Researchers from Case Western Reserve University and the U.S. Department of Veterans Affairs, continue their development of a neuroprosthetic which comprises a system of implanted or wearable sensors.
Headlines in March about Cartesian Therapeutics Inc. reminded investors of the firm’s already-intriguing push with Descartes-08, an autologous anti-BCMA mRNA CAR T therapy, in the works for myasthenia gravis and systemic lupus erythematosus. Excitement generally is mounting around prospects for CAR T therapies in autoimmune disease, where developers aplenty are pursuing early stage opportunities.
Medtronic plc hit a sweet spot with its diabetes devices, with the unit leading the company in growth in its first quarter 2025 results. Diabetes device sales grew 11.8% to $647 million for the quarter, an important boost that pushed total revenue up to $7.9 billion ($8.01 billion, adjusted), a 2.8% reported increase or 5.3% exchange rate impact. No other unit saw more than single-digit increases in sales.
Getinge AB agreed to acquire Paragonix Technologies Inc. for $477 million, including upfront and earn out payments. The deal marks Getinge’s entry into the global organ preservation and transportation market, a rapidly advancing field driven by rising transplant volumes, technological innovations and evolving clinical practices.
The ever-contentious issue of drug pricing creates a tug-of-war between biopharma’s innovation machine and the general population’s need for accessible and affordable drugs. BioWorld has covered the issue of drug pricing from insulin caps and the early days of the IRA to failed legal challenges and the recent rollout of the Centers for Medicare & Medicaid Services’ negotiated prices. Read our collection of 2024 stories.
With biopharma IPO volume at a 10-year low, two companies are bucking the trend with plans to plunge into the public market. Bifunctional antibody drug developers Bicara Therapeutics Inc. and Zenas Biopharma Inc. have filed with the SEC to go public though neither has named share-price ranges.
The long struggle by Boston-based I2o Therapeutics Inc.’s business unit Intarcia Therapeutics to get long-lasting exenatide for diabetes onto the market ended with a final thumbs-down from the U.S. FDA because of safety concerns. At issue was ITCA-650, a twice-yearly implantable exenatide-device combo meant to improve glycemic control in adults with type 2 diabetes.
The U.S. Federal Trade Commission’s broad rule banning noncompete employment clauses was struck down by the U.S. District Court for the Northern District of Texas. In a final judgment from Judge Ada Brown, the court set aside the noncompete rule, saying it won’t be enforced or take effect as planned on Sept. 4.
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