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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
AI models developed by GE HealthCare used readily available clinical data to forecast cancer immunotherapy outcomes and adverse reactions with 70-80 percent accuracy, according to an article published in the Journal of Clinical Oncology Clinical Cancer Informatics. Read More
The FDA met its March 5 deadline to provide Vanda Pharmaceuticals with the details of its decision to deny the company’s request for a hearing on an sNDA for a jet lag disorder treatment, finding “that there is no genuine and substantial issue of fact justifying a hearing.” Read More
President Biden announced on Monday that manufacturers for all ten drugs have agreed to participate in the Inflation Reduction Act (IRA) drug price negotiations — but that negotiations continue as all drugmakers have submitted counter offers. Read More
In a likely boost to Joe Biden’s affection for Delaware, a federal judge in U.S. District Court there Friday handed a victory to the President’s much-challenged Inflation Reduction Act (IRA), in another setback for big pharma in challenging the Medicare Part D drug pricing program. 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
The FDA’s Medical Imaging Drug Advisory Committee (MIDAC) meets Tuesday to tackle concerns about Lumisight, a device-injection combo product from Lumicell designed to help clinicians detect residual breast cancer following tumor removal. Read More
The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand. Read More