HD Medical Awarded FDA Clearance For HD Steth
14.7.2020 15:05:00 EEST | Business Wire | Press release
HD Medical, Inc. of Silicon Valley today announces that its flagship product, HD Steth, has received FDA clearance for all three product classification codes of DQD, DQC and DPS for Electronic Stethoscope, Phonocardiograph and Electrocardiograph combined into one device. HD Steth utilizes cutting-edge AI technology to enable clinicians to perform advanced cardiac evaluation at the point-of-care to save time and lives.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200714005235/en/
HD Steth and HD Steth App (Photo: Business Wire)
About HD Steth
HD Steth is an intelligent stethoscope that assists clinicians with capturing, recording, replaying and simultaneously visualizing heart sounds and ECG waveforms on a smart device to help detect multiple cardiac abnormalities. Patented visualization and noise cancellation technology gives HD Steth its edge. Subtle heart sounds are difficult or impossible to hear during auscultation. HD Steth delivers unsurpassed sound fidelity enhanced by visualization which allows clinicians to see the heart sounds providing instant cardiac insights.
Clinical Studies & International Sales Success
“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, specializing in Cardiovascular Disease in Flint, Michigan. “The opportunity to amplify the sounds along with simultaneous visualization of heart sounds and ECG in real-time is unique. Physicians, teachers and medical students will greatly benefit from this revolutionary experience which will be a paradigm shift in cardiac auscultation. Congratulations to the HD Medical team for combining all these sensors that resulted in this exceptional instrument which will benefit the patient population as well as providers for years to come. It is truly a giant leap forward in technology.”
“HD Steth is the only stethoscope with four powerful microprocessors built into the device for advanced signal processing and intelligence, while still retaining the convenient form factor of a stethoscope,” said Shailendra Mahajan, board observer and managing director of Maxim Ventures, a major investor in HD Medical. “Components and sensors by Maxim Integrated Products, Inc. (NASDAQ: MXIM) enable low power consumption and better accuracy. The combination results in significant advantages over other products in the market.”
“Over the past year, HD Medical has been conducting multiple screening studies of over 50,000 children using HD Steth in India and has resulted in saving many lives. HD Medical has been selling internationally to medical professionals and institutions as well as domestically to veterinarians with great success. HD Medical can now market HD Steth in the U.S. and in other FDA-predicated global markets,” said Arvind Thiagarajan, founder & CEO of HD Medical. “The most intelligent stethoscope has been FDA cleared at this critically important time. During this challenging COVID-19 pandemic, HD Steth will significantly assist frontline health workers at the point-of-care detecting abnormal heart and lung sounds," he continues, welcoming the medical community to High-Fidelity Digital “HD” sound and instant visualization.
About HD Medical, Inc.
HD Medical, Inc. is a Silicon Valley-based innovator of digital health solutions for AI-enabled detection and management of cardiovascular disease (CVD). HD Steth has been awarded FDA clearance (K201299) for Product Classification Codes: DQD, DQC, DPS. The company delivers its intelligent cardiac care solutions and products globally to medical professionals and institutions as well as veterinarians through channel partners. For more information please visit www.hdmedicalgroup.com.
Note to editors: HD Steth and HD Medical are registered trademarks of HD Medical, Inc.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200714005235/en/
Contact information
Kristi Furrer
HD Medical, Inc.
303.525.0924
kristi@hdmedicalgroup.com
info@hdmedicalgroup.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Newmont Announces Key Executive Appointments for the Next Phase of Delivery16.6.2026 00:20:00 EEST | Press release
Newmont Corporation (NYSE: NEM, ASX: NEM, PNGX: NEM) (“Newmont”) today announced leadership appointments that further shape its go-forward Executive Leadership Team under President and Chief Executive Officer Natascha Viljoen and reflect the depth of leadership talent within the company. Effective July 1, 2026, Brian Tabolt has been appointed Chief Financial Officer, Mark Rodgers has been appointed Chief Operating Officer, and David Thornton has been appointed Chief Technical Officer. In addition, David Fry has been promoted to Executive Vice President, Project Development, reflecting the importance of disciplined project development and execution as Newmont advances its highest-return growth opportunities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615487768/en/ Mark Rodgers - COO “These appointments bring together respected leaders with deep industry experience and a strong understanding of our operational, financia
Westlake Expands Global Chlorovinyls Manufacturing Capacity With Acquisition of PVC and VCM Plants in Wilhelmshaven, Germany15.6.2026 21:18:00 EEST | Press release
Westlake Corporation (NYSE: WLK) (“Westlake”) announced today that its German subsidiary, Westlake Vinnolit GmbH & Co. KG, has completed the previously-announced acquisition of a polyvinyl chloride and vinyl chloride monomer production site located in Wilhelmshaven, Germany (the “Wilhelmshaven plant”). The Wilhelmshaven plant, which was previously in insolvency administration, has the capacity to produce 380,000 metric tons of PVC per year. “This acquisition strengthens our Performance & Essential Materials business by expanding our global chlorovinyls manufacturing footprint and complements our existing chlorovinyl production facilities in Europe and North America,” said Jean-Marc Gilson, President and Chief Executive Officer of Westlake. “The Wilhelmshaven plant, which is located in Lower Saxony on Germany’s North Sea coast, benefits from advantageous logistical infrastructure, including a deep-water dock that enables efficient raw-materials supply. We look forward to welcoming the s
Onera Announces Integration of the Onera hPSG® Solution With Somnoware15.6.2026 20:35:00 EEST | Press release
Onera Health, a leader in transforming sleep medicine, announces that its end-to-end home polysomnography solution, the Onera hPSG® solution, now integrates with Somnoware by ResMed sleep lab management software. This integration enables clinicians to conduct Polysomnography tests (PSGs) where patients sleep most comfortably, in their own home, while managing the entire workflow in Somnoware. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615106079/en/ Onera hPSG®, an end-to-end home polysomnography solution from Onera Health, is now integrated into Somnoware, enabling their shared customers to conduct Polysomnography tests (PSGs) in the patient's home while managing the entire workflow in Somnoware. “The integration with Somnoware is a welcomed enhancement that broadens access to the Onera hPSG® solution,” states Ruben de Francisco, Founder and CEO of Onera Health. “Many sleep centers are customers of both Onera and Somn
Digital Cooperation Organization Launches Global Expert Community to Accelerate International Digital Cooperation15.6.2026 19:18:00 EEST | Press release
The Digital Cooperation Organization (DCO), the world's first standalone international organization dedicated to inclusive and sustainable digital economy growth, today announced the launch of the Global Expert Community (GEC) — a new platform designed to mobilize expertise and advance international collaboration in support of high-impact digital initiatives across DCO Member States and beyond. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615565781/en/ Digital Cooperation Organization Launches Global Expert Community to Accelerate International Digital Cooperation (Graphic: AETOSWire) The GEC reflects the DCO's continued commitment to turning digital cooperation into action by expanding access to specialized expertise and strengthening collaboration across sectors and borders. As digital transformation reshapes economies and societies worldwide, the Community is designed to convert global perspectives and practical expe
New Pivotal Study Data Show Takeda’s Oveporexton Improved Daily Function, Cognition and Nighttime Sleep for People with Narcolepsy Type 115.6.2026 19:00:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK)today presented additional results from two pivotal studies at SLEEP 2026, showing oveporexton (TAK-861), an oral orexin receptor 2 (OX2R)-selective agonist, improved daily functioning as well as cognitive and sleep-related symptoms associated with narcolepsy type 1 (NT1).1,2,3 Oveporexton is designed to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling. These data, along with previously disclosed Phase 3 results, demonstrated improvement across the broad disease spectrum, supporting the potential of oveporexton to redefine the standard of care for NT1.4 "Narcolepsy type 1 is a 24-hour disease driven by orexin deficiency, and while excessive daytime sleepiness and cataplexy are the most recognized symptoms, many people experience additional bothersome symptoms such as cognitive difficulties and disrupted nighttime sleep," said Emmanuel Mignot, M.D., Ph.D., principal investigator for the FirstLight (TAK-861-3001) Phase 3 stu
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom