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At its best, AI could “radically change” clinical practice and patient outcomes, and realign the country’s medical reimbursement system to reward excellence in both those areas, according to FDA Commissioner Robert Califf. Read More
The FTC, Department of Justice (DOJ) and HHS have jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over healthcare, further signaling the Biden administration’s commitment to lowering healthcare costs. Read More
With stern warnings of potential seizure, injunctions and civil money penalties for failure to comply, the FDA’s warning letter to Fresenius Kabi’s spells out multiple areas in need of corrective action in the company’s manufacture of its Ivenix infusion system components. Read More
On Tuesday, the FDA’s Medical Imaging Drug Advisory Committee (MIDAC) green lighted Lumicell’s device-injection combo product aimed at helping surgeons detect residual breast cancer in breast tissue after lumpectomies. Read More
Digital health technologies are uniquely effective tools for screening, diagnosing, and managing both type 1 and type 2 diabetes, according to stakeholders who commented in response to the FDA’s request for input on digital health technologies (DHT) for detecting prediabetes and undiagnosed type 2 diabetes. Read More
This week, a company pares down those giant robotic surgery systems, a drug-coated angioplasty balloon opens coronary arteries with pressure and medication, an ablation system eases the pain of metastatic bone lesions, and a new fixation device stabilizes the sacroiliac joint without the need for lateral screws. Read More
GE HealthCare subsidiary, Datex-Ohmeda’s recall of EVair and Jun-air compressors has been deemed Class I by the FDA due to potentially elevated levels of formaldehyde emissions. Read More
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More