Fierce Biotech January 5, 2024
The maker of a wearable garment for tracking heart rate, breathing and physical activity has obtained an FDA clearance for artificial intelligence-powered software that enables continuous monitoring of blood pressure without an inflatable cuff.
Fit snugly across a person’s chest, Nanowear’s SimpleSense wearable is built with cloth-based sensor technology to provide medical-grade remote vital sign tracking, including ECG data and heart sounds.
The new 510(k) green light—marking the company’s fourth—for the SimpleSense-BP program aims to support the at-home diagnosis of hypertension, as well as within healthcare facilities or clinical studies. Everyday settings can lead to more accurate readings than under the examination of a physician, where anxiety may raise blood pressure levels while calm, controlled breathing may lower them.
“This...
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