Sleeping Dragon: Personal Biometric Tracking Startups Beware...the FDA?

What to do if you’re an EnteroMedics Inc. investor?

The company, which is developing a device that uses electricity to treat obesity and diabetes, Thursday said data from a key clinical trial showed its VBLOC therapy “remain encouraging, with signs of clinically meaningful weight loss and control of obesity.” Furthermore, patients using a more advanced version of the Maestro device for 14  hours a day lost weight and demonstrated significantly reduced levels of HbA1c (glycated hemoglobin) levels in the blood.

Sounds good. One major problem: EnteroMedics is a company dangling precariously off a cliff. Last fall, Enter0Medics said initial results from its Empower clinical study failed to meet its goals.

From: "EnteroMedics Inc.’s fate now in the hands of the FDA. Your guess is as good as mine: MedCity News."

Wonder what will happen if the FDA starts evaluating marketing claims made by personal biometric tracking devices like FitBit, WakeMate, etc?

Posted via web from Jen's Posterous

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