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 MobiHealth News, in “Viz.ai’s Stroke-Detecting CDS App Receives FDA Nod,” by Dave Muoio.
Following is an excerpt:
The FDA announced yesterday that it will permit marketing of Viz.ai’s Contact, a clinical decision support (CDS) tool that analyzes CT results and highlights cases that may have experienced a stroke.
The CDS application was submitted through the agency’s de novo premarket review pathway, and as such creates a new regulatory classification for similar AI-drived platforms to come. The FDA’s decision comes just a couple of months after the agency released its long-awaited, and somewhat controversial, draft guidance on CDS outlining which tools would and would not be regulated by the agency. …
Reactions from industry experts and analysts were mixed at the time, but comments submitted to the FDA last week 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. The letter urged the FDA to exempt low-risk CDS software from oversight, called for better alignment with the goals of the Cures Act, and stressed that the current draft would remove many existing CDS software companies from the market.
On a particularly relevant note, the letter also expressed concerns over the handling of machine learning CDS technology, as even low-risk products would be subject to FDA regulation under the current draft’s language.
“There is non-low risk CDS software that should be permitted to use machine learning without FDA oversight,” Bradley Merrill Thompson, an attorney with Epstein Becker Green, wrote on behalf of the CDS Coalition. “We believe that such software can meet the exemption under the Cures Act (despite the language in the Draft Guidance), as long as the relevant portions of our Coalition Industry Guidelines are followed.”