Dexcom wins FDA clearance for G6 Pro CGM

Dexcom (NSDQ:DXCM) said today that it won 510(k) clearance from the FDA for its G6 Pro continuous glucose Monitor for diabetic patients ages ages two years and up.

The San Diego-based company said the G6 Pro is designed to measure glucose data in real time over 10 days in either “blinded” or “unblinded mode,” depending on whether the data is hidden from the patient for later review with a healthcare provider or provided to the patient in real time.

“At Dexcom, we are continuing to drive innovation in wearable health technology,” chairman, president & CEO Kevin Sayer said in prepared remarks. “Using the power of Dexcom G6 Pro, clinicians can use the insights gained from a 10-day professional CGM session to adjust treatment plans and empower their patients to live healthier lives.”

“Dexcom G6 Pro will enable healthcare providers to set up their patients with CGM in minutes,” added diabetes specialist Davida Kruger, of Detroit’s Henry Ford Health System in Detroit. “This new professional system will serve as a simple way to obtain data from CGM naïve patients who need glucose insight, but don’t need or want to be monitored around the clock. It will give all my patients a chance to try the Dexcom G6 Pro under a healthcare provider’s supervision before they commit to a personal system.”

Dexcom said it expects to begin shipping the G6 Pro early next year.

DXCM shares were off -2.2% to $26.35 apiece today in early trading.