VoluMetrix’s Heart Failure Monitor Gets Breakthrough Device Status
Nashville-based biotech startup VoluMetrix has received FDA Breakthrough Device status for a device that monitors patients for signs of heart failure.
The noninvasive venous waveform analysis heart failure device is designed to monitor the energy-based signal generated by heart and respiratory activity.
The FDA’s Breakthrough Device designation is intended to give patients more timely access to new devices by expediting their development and review. It is available for devices reviewed under a premarket approval application, 510(k) premarket notification or De Novo classification request.