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.
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?
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.
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.
Day Zero Diagnostics Inc. and Oxford Nanopore Technologies plc (ONT) joined forces to battle the leading cause of death in hospitals — sepsis. Combining Day Zero’s whole genome sequencing technology for pathogen identification and antimicrobial susceptibility analysis with Oxford’s nanopore-based molecular sensing technology, the companies aim to develop a diagnostic system that provides potentially life-saving identification and guidance on antimicrobial selection in mere hours.
Olympus Corp., of Center Valley, Pa., reported Nov. 9 a voluntary field corrective action for bronchoscopes prompted by complaints of endobronchial combustion during procedures that involve the use of high-frequency (HF) therapy equipment.
Therabionic GmbH received U.S. FDA humanitarian device exemption (HDE) for its P1 device for at-home treatment of hepatocellular carcinoma, which accounts for 80% of all liver cancers, in patients who have failed first- and second-line therapies.
The U.S. FDA granted Roche Holding AG breakthrough device designation for its Elecsys Neurofilament Light Chain test for multiple sclerosis. The Elecsys NfL test can aid in the detection of disease activity in adults, 18-55 years old, with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis. It also provides critical information for managing the disease.
Carrying through on a policy it adopted a few months ago to crack down on potentially anticompetitive FDA Orange Book listings, the U.S. FTC put 10 drug companies on notice that it’s challenging several of their “improperly or inaccurately listed” patents through the FDA’s regulatory dispute process.
Johnson & Johnson expects to submit the long-awaited Ottava robotic surgical system to the U.S. FDA for an investigational device exemption (IDE) in the second half of 2024, nearly three years later than the company anticipated when its Ethicon Inc. unit acquired Ottava along with Auris Health Inc. in 2019.
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