BRADLEY MERRILL THOMPSON is a Member of the Firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.
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Visualizing a network is a matter of nodes and edges. Instead of people, we are going to look at specific device functionalities as defined by the product codes.
At the top of the Food and Drug Administration’s agenda for the next 12 months: clarifying the rules for AI in healthcare. The FDA’s Center for Devices and Radiological Health (CDRH) recently shared a list of proposed guidances it plans to publish in fiscal year 2022. To start, the agency plans to publish a long-awaited final guidance on the use of clinical-decision support tools. It would come at a time when the software tools, such as sepsis alerts for clinicians, have come under scrutiny as researchers find they’re not always as accurate as advertised. The FDA has been working on guidance to address this since the 21st Century Cures Act passed five years ago, but has yet to finalize it. Under the most recent proposed draft, the FDA would look to expand its oversight of algorithms used to treat serious conditions, in addition to those where clinicians can’t review the basis for the suggestion. The change drew several comments, with some groups, like the American Hospital Ass