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 Becker’s Hospital Review, in “Why the FDA’s Recent Glucose Monitoring System Approval Matters for Interoperability,” by Jessica Kim Cohen.
Following is an excerpt:
The FDA recently approved what it calls the “first fully interoperable continuous glucose monitoring system,” signaling a newfound comfort with data exchange standards, according to an industry expert.
On March 27, the FDA permitted the marketing of the Dexcom G6 integrated continuous glucose monitoring system for diabetes patients aged 2 and older. Like most continuous glucose monitoring systems, Dexcom’s device contains a small sensor that monitors a patient’s blood glucose level and transmits real-time glucose readings to a compatible mobile device.
However, Dexcom’s device is also one of the first continuous glucose monitoring systems to work with other medical devices, including automated insulin dosing systems, insulin pumps and blood glucose meters.
“[T]he agency appears to be getting comfortable with what it takes to make an interoperable claim,” Bradley Merrill Thompson, a digital health expert and lawyer at Epstein, Becker and Green, told the Politico Morning eHealth newsletter. “I can’t recall FDA using the word ‘interoperable’ in an approval or clearance, but perhaps they have.”