- The FDA has approved Dexcom’s glucose monitoring system for checking blood sugar levels in children and adults with diabetes.
- The Dexcom G6 is first such system to be fully interoperable with other compatible medical devices and electronic interfaces such as automated insulin dosing systems and insulin pumps.
- Separately, the agency is expanding its digital health precertification pilot program over the course of the year, RAPS reports. The pilot launched in September with nine companies including Apple, Fitbit and Alphabet’s Verily life sciences arm, with the aim of assessing a developer instead of a product to see if they meet quality standards and should be precertified.
The FDA decision was via the de novo premarket review pathway, which is available for novel, low-to-moderate-risk devices that do not have an existing predicate on the market.
The approval establishes integrated continuous glucose monitoring systems as Class II devices, meaning future such devices can be cleared via the less-rigorous 510(k) process.
The move is intended “to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability,” Donald St. Pierre, acting director in the FDA device center’s Office of In Vitro Diagnostics and Radiological Health, said in a statement.
Population health management is hot, and the CMS 2018 physician fee schedule final rule acknowledged growing interest in remote patient monitoring. The rule unbundled a code for RPM, allowing doctors to seek reimbursement for collecting and interpreting health data this generated remotely by patients, digitally stored and sent to providers, within a minimum of 30 minutes.
The change opened the door for broader use of remote monitoring in disease and population health management. Medicare previously covered a code for chronic care, but didn’t cover RPM — limiting its uptake, Gary Capistrant, chief policy officer at the American Telemedicine Association, told Healthcare Dive in December.
A prior version of Dexcom’s monitoring system won FDA approval in 2016, but was not designed for use with other devices.