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Most predictive clinical decision support devices (CDS) that rely on machine learning (ML) or AI are approved and marketed without adequate proof that they deliver on their promise of improving outcomes for patients with critical illnesses, a study has found. Read More
HistoSonics’ Edison System, which uses focused ultrasound to mechanically destroy and liquify unwanted liver tissue and tumors, has received de novo marketing authorization from the FDA and is the first histotripsy platform available in the U.S. Read More
Guidance updates, Novo Nordisk complaint against semaglutide compounders tossed, and AdvaMed forms new digital tech division, in this edition of Quick Notes. Read More
The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of AI/machine learning (ML) and increased collaboration between the agency and industry. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
The FDA “remains unsatisfied” with Philips Respironics’ handling of the recall of its 15 million ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines. Read More
This year, those making combination products find themselves in a swirl of potentially confusing regulations and standards regarding risk management. Read More
Seeking to address the growing problem of how misinformation undermines confidence in both science and the FDA, the Regan-Udall Foundation has released a report focusing on how the FDA can deliver clear messaging to deliver improved understanding of the FDA and the products it regulates. Read More
Over the past week, the FDA issued a proposed rule on laboratory developed tests, final guidance on labeling for dosing of human prescription drugs and biological products and draft guidance on stimulant drug use disorders. Read More