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Home » FDA clears HD Medical’s smart stethoscope

FDA clears HD Medical’s smart stethoscope

July 14, 2020 By Chris Newmarker

HD Medical HD Steth intelligent smart stethoscope artificial intelligence AI
The HD Steth system [Image courtesy of HD Medical]
HD Medical said today that it’s secured FDA clearance for its HD Steth, which uses artificial intelligence to enable clinicians to perform an advanced cardiac evaluation at point-of-care.

The FDA clearance covers all three product classification codes of DQD, DQC and DPS for an electronic stethoscope, phonocardiograph and electrocardiograph — all combined into one device. Four microprocessors back up the HD Steth technology, with components and sensors fro Maxim Integrated Products enabling lower power consumption and better accuracy.

“The quality and intensity of heart sounds are phenomenal on HD Steth, and it delivers the most impressive sound quality advancements in my last 40 years of stethoscope use,” said Dr. Ethiraj Raj, a cardiovascular disease specialist in Flint, Mich.

“The opportunity to amplify the sounds along with simultaneous visualization of heart sounds and ECG in real-time is unique,” Raj said in a news release. “Physicians, teachers and medical students will greatly benefit from this revolutionary experience which will be a paradigm shift in cardiac auscultation.”

Filed Under: 510(k), Diagnostics, Digital Health, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: AI, artificial intelligence, HD Medical

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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