Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practices, in the Washington, DC, office, was quoted in an article titled "Busy Week for FDA and Mobile Health, But No Final Guidelines Yet."
Following is an excerpt:
Biosense's urinanalysis app uChek was using other medical devices — urine test strips — that were only cleared to be interpreted by the human eye, not a smartphone app's camera or algorithm. Epstein Becker's Bradley Merrill Thompson, who is also the co-founder of the mHealth Regulatory Coalition and a longtime MobiHealthNews columnist, has been pointing to the uChek app for the past few months as an example of an app that the FDA should be enforcing its medical device guidelines against. Thompson even made mention of the app during his testimony at a congressional hearing in February.
