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.”