FDA Clears Novel Device Providing Digital Makeover to Stethoscopes

The humble and ubiquitous stethoscope is getting a digital makeover.

Pennsylvania startup Rijuven Corp. announced Wednesday that the FDA has cleared a first-of-its-kind stethoscope accessory device that allows clinicians to get 3-Lead ECG and Digital Auscultation. The device can also connect wirelessly to mobile devices.

The ability to listen to the heart using the traditional stethoscope and make a correct diagnosis depends largely on the expertise and training of the physician. In many cases, physicians may order additional tests like an ECG to get a clearer picture of the condition of the heart.

With the CardioSleeve, the physician can simply attach the device to the stethoscope enhancing that device by “recording, displaying and analyzing electrical and acoustical footprints of the heart in real time via any wirelessly connected portable device,” according to a company news release. A 3-Lead ECG can be performed by using a monitoring device typically placed on a cart that uses wired electrodes attached to the patient to bring up readings.

By comparison, the CardioSleeve aims to achieve a similar result by attaching on to the stethoscope and displaying the results on mobile devices like a smartphone, laptop, PC or a tablet

The product is set to be available by the fourth quarter.

“With over 40 million stethoscopes, used worldwide, Rijuven’s innovative add-on CardioSleeve digital technology will help revolutionize assessment and diagnosis of patients far more effectively, efficiently, and empathetically at any point of care, in almost any clinical scenario...” said Dr. Raj Kapoor, Rijuven’s founder and president, in prepared remarks.

The company appears to have had one round of funding in which it raised $875,000 according to a regulatory filing from August, 2012.

[Photo Credit: iStockPhoto.com use Tolimir]

-- By Arundhati Parmar, Senior Editor, MD+DI