The U.S. FDA’s approach to bias covers a large swath of territory, including the potential for bias to creep invisibly into artificial intelligence (AI) products. Yarmela Pavlovic, vice president for global regulatory affairs at Medtronic plc, said at this year’s Artificial Intelligence Summit that regulators may be more wary of the potential hazards of bias in AI compared to non-AI software simply because of the difficulty in anticipating how bias might affect the function of these advanced algorithms.
After Cormedix Inc. navigated manufacturing issues that slowed the process, the U.S. FDA approved the antibacterial and antifungal solution Defencath to reduce catheter-related bloodstream infections adults with kidney failure.
The U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee has a lot to discuss Nov. 17, but only one voting question: Does the evidence demonstrate that Merck & Co. Inc.’s gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained chronic cough?
The time to diagnosis of sepsis infection to a patient in the hospital can be critical, with underdiagnosis resulting in rapid deterioration, risk of organ damage and need for readmission, and overdiagnosis leading to the avoidable and sometimes serious health consequences of overtreating patients with broad-spectrum antibiotics.
Lunit Inc. is the latest South Korean firm to gain the U.S. FDA’s 510(k) clearance for Lunit Insight DBT, its artificial intelligence (AI)-powered breast cancer diagnostic tool that analyzes digital breast tomosynthesis (DBT) images, boosting its efforts to enter the U.S. market. The company also reported that it secured $150 million in a public offering.
The artificial intelligence (AI) space doesn’t exactly lack for stakeholders, but the roster of stakeholders in the U.S. is poised to grow by hundreds of millions, according to Laura Adams, senior advisor at the U.S. National Academy of Medicine.
If everything goes according to the current plan, the U.S. FDA would get the final report of a confirmatory trial for Acrotech Biopharma Inc.’s Folotyn (pralatrexate) and Beleodaq (belinostat) in 2030 – more than two decades after Folotyn received accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma and 16 years after Beleodaq was granted accelerated approval for the same indication.
With the U.S. FDA giving the green light to Takeda Pharmaceutical Co. Ltd.’s Adzynma for treating a rare blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme, the company has won two approvals in two days after the FDA approved fruquintinib a day earlier.
The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review process has drawn fire from inventors as a patent-killing machine.
In the following years, 2023 may come to be seen in medical device circles as the year of artificial intelligence (AI), but that doesn’t mean that 2023 will be seen as the year of regulatory clarity for AI.
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