Wexford, Pennsylvania-based Rijuven has received FDA 510(k) clearance for its CardioSleeve device, which turns a doctor's stethoscope into a mobile-enabled 3-Lead ECG device with digital auscultation. That is, it includes a clinical decision support system that helps doctors evaluate heart murmurs.
According to the company's website, with the CardioSleeve device attached, the stethoscope records the sound of a patient's heartbeat as well as their ECG data. It can connect to a smartphone, tablet, laptop, or desktop computer via Bluetooth and has a rechargeable lithium-ion battery. All the data can be stored in the cloud for HIPAA-compliant viewing by a doctor or uploaded into an EHR, according to the company.
"Our CardioSleeve is a unique stethoscope accessory device for acquiring the acoustic and electrical footprints of the heart, with results being displayed on embedded and mobile devices, and decision support software to record and analyze acoustic heart signals," President Raj Kapoor writes on the company's site. "It greatly reduces health care cost due to a more accurate and timely diagnosis and provides objective, repeatable findings that are easily archived and retrieved as electronic medical record."
CardioSleeve is FDA-cleared for prescription use only. "CardioSleeve is not intended to be a diagnostic device," the company states. "It does not supersede the judgment of the clinician. The device is intended to aid the physician in the evaluation of heart sounds. The clinicians are responsible for reviewing and interpreting the results, along with the auscultatory findings and medical history, when making a referral decision."
Rijuven, which was founded in 2012, intends to release its first products this year. In addition to CardioSleeve, the company is working on a health and wellness device called mBrace, which will measure Heart Rate Variability (HRV) from an ECG sensor. It will use that data to provide the user with biofeedback and breathing exercises.
Several other notable digital health companies received FDA 510(k) clearances last month:
- Zephyr Technology, makers of the Zephyr BioHarness physiological monitoring system, received clearance for a physiological data processor. The company announced a $4.2 million funding round in May.
- Proteus Digital Health received another clearance, for a "Proteus patch including ingestible sensor." Proteus had a clearance last month as well, which may suggest the company readying its products to prepare for a major launch. Proteus also announced funding in May -- $45 million -- and recently partnered with Oracle.
- GE-Intel's Care Innovations got clearance for an update to its Care Innovations Guide platform (formerly Intel Health Guide), a remote care management system.
- AirStrip Technologies received clearance for a "Philips adapter." AirStrip partnered with Philips back in March, shortly before announcing that it had settled a patent infringement lawsuit against mVisum, a previous partner of Philips. Philips' Intellivue Patient Monitor also received an updated FDA clearance of its own, which could be related to the AirStrip partnership.