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
SPORVIGILANCE Targets Safer Medicines and Billion-Euro Savings for Global Pharma Facing EU IDMP Fines28.9.2026 09:13:00 EEST | Press release
British regulatory technology company SPORVIGILANCE is targeting one of global pharma’s major compliance challenges with a platform offering a faster route to IDMP and SPOR readiness, compliance and governance. As the European Medicines Agency advances structured medicinal product data, companies face pressure to keep regulatory data accurate, standardised and aligned with EMA requirements. SPORVIGILANCE replaces fragmented manual assessment with a regulatory intelligence layer built around IDMP, SPOR and Product Management Service (PMS) requirements. At its core is an IDMP Business Rule Validation Engine that assesses medicinal product data at scale and at field level, identifying missing, inconsistent and non-compliant data. SPORVIGILANCE is the only platform to translate IDMP business rules directly into automated validation logic, enabling companies to test data against the rules rather than rely on manual interpretation. Its PMS Alignment capability reconciles internal RIM data ag
Sofinnova Partners Closes Oversubscribed €82 Million Sofinnova MD Start IV Fund to Create the Next Generation of Medtech Companies28.9.2026 09:00:00 EEST | Press release
Sofinnova Partners ("Sofinnova"), a leading European life sciences venture capital firm based in Paris, London, and Milan, today announced the final close of Sofinnova MD Start IV at €82 million. The fund, which was oversubscribed, will help expand Sofinnova's medtech company-creation strategy across Europe and the US with greater capacity to launch new ventures and support them through key stages of development. With plans to launch six to eight new medtech companies over the next five years, Sofinnova MD Start IV will support ventures from inception through key clinical and operational milestones, providing founders with both capital and hands-on support. Sofinnova MD Start's approach combines clinical insight, entrepreneurial talent, and operational expertise to tackle significant unmet medical needs. The previous fund, Sofinnova MD Start III, a €63 million fund, invested across six companies that have collectively raised more than €140 million in follow-on financing. Sofinnova MD S
Ant International’s Antom Upgrades Southeast Asia Leadership Structure to Drive Regional Synergy in the AI Era28.9.2026 08:18:00 EEST | Press release
Antom, a leading merchant payment and digitisation services provider under Ant International, today announced a series of key appointments for its operations in Southeast Asia to further strengthen the synergy among its regional brands and better serve regional merchants with streamlined full-stack AI-native solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260927431282/en/ Nabilah Alsagoff, co-founder and former chief operating officer of DOKU, Indonesia's leading payment fintech company, has been appointed as Head of Product, Antom SEA. In her new role, the payment veteran will oversee product development and innovation and drive a unified product roadmap for the overall SEA region. Chris Yeo, former chief executive officer (CEO) of DOKU, will take on the role as Head of Antom Philippines, and Country Head of 2C2P Philippines. With his long experience at DOKU, Grab and PayPal, Chris will also oversee the execution
UAE Opens 15 th UN Congress on Crime Prevention and Criminal Justice and Launches Pledge4Justice with First Pledge of Up to USD 5 Million26.9.2026 23:51:00 EEST | Press release
The 15th United Nations Congress on Crime Prevention and Criminal Justice – Abu Dhabi 2026 kicked off today at ADNEC Centre Abu Dhabi. Set to run until 1 October, the Congress attracts representatives from over 97 countries, including over 32 ministers of justice and interior ministers, alongside senior officials, judges, prosecutors, experts, and youth from around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260926005703/en/ UAE Opens 15th UN Congress on Crime Prevention and Criminal Justice and Launches Pledge4Justice with First Pledge of Up to USD 5 Million (Photo: AETOSWire) The opening session witnessed the adoption of the Abu Dhabi Declaration, which serves as the Congress's principal political and strategic outcome document and will guide international priorities and cooperation in crime prevention, criminal justice and the rule of law over the next five years. The Declaration is structured around four pi
Future Health Convenes Global Health Leaders at UNGA to Advance Health System Transformation at Scale26.9.2026 18:21:00 EEST | Press release
Future Health – A Global Initiative by Abu Dhabi convened Ministers, senior government representatives, and global health leaders in New York on the sidelines of the 81st Session of the United Nations General Assembly (UNGA 81). The high-level dialogue set out practical priorities for moving health systems from reactive treatment towards prediction, prevention, and earlier intervention. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260926746202/en/ Future Health – A Global Initiative by Abu Dhabi convened Ministers, senior government representatives, and global health leaders in New York on the sidelines of the 81st Session of the United Nations General Assembly (UNGA 81). Chaired by H.E. Ahmed Al Sayegh, Minister of Health and Prevention of the United Arab Emirates, the dialogue brought together participants from Angola, Brazil, Ethiopia, Finland, Guyana, Indonesia, Madagascar, Mali, Nigeria, Rwanda, Sweden, the United Ara
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