Dexcom (NSDQ:DXCM) shares jumped yesterday after the company scored a unique FDA approval for its G6 continuous glucose monitor, marking the first time the U.S. regulatory agency has cleared a CGM as “fully interoperable” with other medical devices.
The company’s latest CGM also eliminates the need for patients to calibrate the device by pricking their fingers. The patch device, which is about the size of a quarter, is calibrated at the factory and can be worn for 10 days at a time.
The Dexcom G6 attaches to the patient’s abdomen and a small sensor continuously measures the user’s blood sugar levels. Every five minutes, the device sends glucose readings to a compatible display device, triggering an alarm if the user’s blood sugar is too high or too low.
“We listen closely to people with diabetes and continuously look for ways to empower them to better manage their condition. The FDA’s special controls set a rigorous, new standard in our industry and clearly define the process by which other CGM systems may be approved,” CEO Kevin Sayer said in prepared remarks. “We believe the new Dexcom G6 is a significant step forward for Dexcom and our industry.”
The FDA issued a first-of-its-kind approval to Dexcom, clearing the G6 system to combine with other compatible medical devices and electronic interfaces – including automated insulin dosing systems.
“The ability of this device to work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics & Radiological Health, added. “In addition, the FDA has taken steps 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.”
DXCM shares were trading at $73.05 apiece in pre-market activity today, up 4.4%.
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