MedTech Dive January 5, 2024
Nick Paul Taylor

The company’s continuous blood pressure monitor allows clinical investigators to remotely capture data on patients.

Dive Brief:

  • Nanowear has received 510(k) clearance for AI-enabled software that allows its wearable undergarment to estimate blood pressure.
  • The Food and Drug Administration decision covers software that processes electrocardiogram (ECG) data, heart sounds and thoracic impedance captured by the Simplesense wearable device to monitor blood pressure at home, in healthcare facilities and during medical research.
  • Nanowear is pitching the software as the “first non-invasive, cuffless, continuous blood pressure monitor, and diagnostic.” The company cited Biobeat Technologies’ wrist and chest monitor as a predicate blood pressure device in its 510(k) filing.

Dive Insight:

Simplesense is a cloth-based undergarment that wraps around the wearer’s...

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Topics: Digital Health, FDA, Govt Agencies, Medical Devices, Technology, Wearables
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