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 POLITICO Morning eHealth, in “FDA Approves Interoperable Continuous Glucose Monitoring System,” by Darius Tahir.
Following is an excerpt:
In an advance for diabetics and the medical device industry as a whole, FDA approved Dexcom’s interoperable continuous glucose monitoring system Tuesday.
In one respect, Dexcom’s new system is standard. It tests a patient’s blood glucose level and conveys the data to a cellphone app, which can sound the alarm when levels go outside a safe range. But the interoperability is a key point, as the data can now theoretically be used in other systems, like insulin pumps. In the future, that might allow for full interoperability with automatically adjusting insulin pumps.
Observers were pleased, noting that the move implied much going on beneath the surface. “[T]he agency appears to be getting comfortable with what it takes to make an interoperable claim,” said Bradley Merrill Thompson, an Epstein, Becker and Green lawyer and digital health expert. Interoperable devices – medical devices that can communicate with each other – have been a long-held dream of many in the health care community. …
“I can't recall FDA using the word ‘interoperable’ in an approval or clearance, but perhaps they have,” Thompson said, and it was notable that the agency was open-ended about the devices or software that can interact with the Dexcom device. Thompson surmised that the agency was comfortable with the interoperability standards used to support the approvals.
