Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “FDA Permits Marketing of AI Software That Autonomously Detects Diabetic Retinopathy,” by Dave Muoio.

Following is an excerpt:

The FDA has granted diagnostics company IDx’s De Novo request to market its AI-based software system for the autonomous detection of diabetic retinopathy in adults who have diabetes, called IDx-DR.

This decision represents the first AI-based diagnostic system authorized by the FDA for commercialization in the US that can provide a screening decision without the need for clinician interpretation, according to the agency. The news comes just months after the FDA’s De Novo approval of Viz.AI, another AI software tool that analyzes stroke indicators and highlights CT images that could require additional clinical attention. …

Regulation of CDS tools have been something of a focus for the FDA as of late. In accordance with the 21st Century Cures Act, the agency released draft guidance in December that outlined regulated devices based on the degree of human involvement, as opposed to doing so based on risk.

Reactions from industry experts and analysts were mixed at the time, but comments submitted to the FDA in February by the CDS Coalition — a group that includes representatives from clinical societies, payers, providers, software developers, and other parties — has since framed the draft as a misstep. In a recent contributed column, Epstein Becker & Green’s Bradley Merrill Thompson asserted that the agency has so far fallen short on its promise to take a risk-based approach to clinical decision support software.

“By law, FDA is supposed to focus its limited resources on higher risk technologies both to maximize public health protection, and at the same time to avoid stifling innovation where regulation is unnecessary,” Thompson wrote in the column. “Unfortunately, in developing its new approach to regulating clinical decision support software, FDA has chosen to ignore that basic principle as well as a promise the agency made to Congress and the public.”

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