NY-B-SECUR
4.2.2021 18:02:07 CET | Business Wire | Press release
B-Secur , a leader in EKG/ECG technology, today announced that it has received U.S. Food and Drug Administration (FDA) 510(K) clearance of its HeartKey® software library1 .
B-Secur’s HeartKey® is a suite of powerful EKG/ECG algorithms that uniquely combine user identification, health and wellness to generate accurate data encrypted through the user’s unique heartbeat, which can now be implemented across devices in home or healthcare environments, with the ability to run embedded on device, on the application layer and even via the cloud.
The FDA-cleared HeartKey® algorithms can be quickly and easily integrated in semiconductors for a broad range of devices in the consumer wellness, health monitoring and medical technology sectors, enabling rapid integration of medical-grade EKG/ECG software with those devices. It also provides the potential for all leading technology device manufacturers and healthcare service providers to generate advanced medical-grade wellness and health data from any device and platform.
This significant development from B-Secur comes at an important time for cardiovascular disease (CVD), which is the No. 1 cause of death globally with an estimated 17.9 million people dying from the disease each year, representing 31% of all global deaths2 .
Last year, the COVID-19 pandemic led to additional health complications for those with underlying heart conditions. The virus has also caused irreparable cardiac damage and arrhythmias in people with no underlying heart issues, making heart health and remote monitoring a key priority for patients, clinicians and health service providers around the world. Developed and optimised for everyday devices, HeartKey® provides the ultimate flexibility in integration, truly enabling “EKG/ECG Everywhere.”
Dr. Andrew Mitchell, Consultant Cardiologist at Jersey General Hospital and Honorary Consultant Cardiologist at the John Radcliffe Hospital in Oxford, UK, welcomed the development commenting, “It is excellent and very timely to hear that B-Secur has received FDA clearance for its HeartKey® library. Heart rhythm conditions affect one in four adults, yet many have no awareness that they have a problem that could lead to stroke or heart failure. With the increasing availability of wearable and IoT devices, FDA-cleared solutions like HeartKey® give patients and their doctors additional tools to detect these rhythms early.”
“The inspiration around EKG/ECG and HeartKey® is being able to take biometrics to the next level, enabling the development of trusted biosensing technology,” Alan Foreman, CEO at B-Secur commented. “With HeartKey®, EKG/ECG is used to determine who you are and how you are at the same time, and can help protect lives, data, and devices. With heart disease being the world’s single biggest killer, we are perfectly positioned to help save lives.”
“HeartKey® has been developed to enable scalability of medical grade EKG/ECG across IoT devices, and the award of FDA clearance is testament to HeartKey®’s performance and the very talented team behind it,” Adrian Condon, CTO at B-Secur added. “This clearance should significantly aid our partners and customers increase the speed to market for their technology.”
FDA clearance has been granted for the following EKG/ECG feature algorithms: Signal Conditioning, Heart Rate and Arrhythmia Analysis. The HeartKey® Arrhythmia Analysis algorithm currently includes Atrial Fibrillation, Bradycardia and Tachycardia. As a lot of arrhythmias are typically transient, they are difficult to catch in hospital. With 33 million people experiencing Atrial Fibrillation worldwide, HeartKey®’s FDA-cleared algorithms can support in the detection and management of arrhythmias outside of the traditional hospital environment, allowing clinicians to make more accurate clinical decisions based on larger amounts of data.
FDA clearance of the HeartKey® software library ensures B-Secur customers and partners can have confidence in its world-leading algorithm performance and accuracy. The fully validated, turnkey solution with FDA clearance will ease integration — reducing development time and costs as well as driving speed to market for end devices.
About B-Secur
B-Secur is the next generation in biometrics, creating software solutions that use ECG/EKG biometrics for user authentication and beyond, to health and wellness metrics. We develop licensing partnerships for unique, tailored solutions based on security and health monitoring. Learn more: https://www.b-secur.com
1
Access to U.S. Food and Drug Administration (FDA) HeartKey® clearance details for software library K200884.pdf
2
World Health Organisation, https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
View source version on businesswire.com: https://www.businesswire.com/news/home/20210204005440/en/
Link:
About Business Wire
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
Accertify and Liminal Release First Empirical Study Proving Fraud-Cyber Convergence Works - and Defining How to Do It Right22.7.2026 13:00:00 CEST | Press release
New research across 250 senior leaders identifies four organizational behaviors associated with a 3.4x performance advantage over siloed organizations Accertify, a leading fraud decisioning provider whose Predictive Yes Platform enables merchants to say yes to more good customers, more revenue, and more growth, today released The Convergence Dividend: Quantifying What Fraud-Cyber Convergence Actually Delivers, a landmark proprietary study conducted in partnership with Liminal. The research - spanning 250 Director-level and above fraud, risk, and security leaders across Retail/eCommerce, Travel, Restaurants/QSR, Entertainment & Media, and Marketplaces - is the first large-scale empirical proof that fraud-cyber convergence produces better business outcomes, and the first to identify the specific behaviors that separate top-performing organizations from the rest. While fraud-cyber convergence is a nearly unanimous (94%) recognized priority by respondents, the research found that many orga
New Visa Data Reveals How the FIFA World Cup 2026™ Created Pop-Up Economies Across Canada, Mexico and the United States22.7.2026 13:00:00 CEST | Press release
New Visa data reveals the FIFA World Cup 26™ drove a nearly 20% surge in cross-border transactions across host cities in Canada, Mexico and the United States. After the final whistle blew on the FIFA World Cup 2026™, millions of fans returned home with unforgettable memories and a trail of economic activity that stretched across countries. Every tap to pay left a lasting impact, as spending throughout the tournament delivered a meaningful boost to merchants and local economies across host cities in Canada, Mexico and the United States. According to new data from Visa, the tournament drove significant growth in cross-border spending, international travel, and digital commerce across host cities. The findings show how a major global event creates “pop-up economies,” defined by Visa as temporary, highly concentrated periods of commercial activity that emerge around major cultural, entertainment and sporting events. The data reveals that fans traveled from around the world to follow their
NIQ and Circle K Expand Global Analytics Collaboration Across More Than 12 Countries22.7.2026 12:00:00 CEST | Press release
Expanded agreement enables Circle K’s Business Units to accelerate smarter merchandising, pricing, and operational decisions across North America and Europe NielsenIQ (NYSE: NIQ), a leading consumer intelligence company, and Circle K today announced a multi-year global agreement spanning more than 12 countries across North America and Europe. The collaboration brings together NIQ’s global scale, AI-powered analytics, and deep local market intelligence to help Circle K transform decision-making, accelerate growth, and deliver best-in-class customer experiences across its expanding global footprint. In an increasingly competitive and fast-changing retail landscape, the collaboration enables Circle K to stay ahead of evolving consumer demand, optimize performance, and unlock new growth opportunities across markets. Through NIQ’s AI-driven insights and decisioning platforms, Circle K’s Business Units and Global Center of Excellence will accelerate smarter merchandising, pricing, and operat
Japan's Cross-Border E-Commerce "WAFUU.COM" Unveils Official Mascot Character "Mochi"22.7.2026 10:00:00 CEST | Press release
A tiny happiness from Japan — WAFUU.COM introduces its new official character, Mochi, bringing more joy to fans around the world discovering Japanese products. QRESTIA Inc. (Headquarters: Shibuya, Tokyo; President & CEO: Hidemasa Fukada) is pleased to announce that WAFUU.COM, its cross-border e-commerce site, has unveiled its new official mascot character, Mochi. Mochi will represent WAFUU.COM's warmth and friendliness across its website, social media, campaigns, package inserts, and other creative materials, connecting with fans everywhere. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721435469/en/ Mochi, WAFUU.COM's new official mascot character, embodies "A tiny happiness from Japan." (Photo: WAFUU.COM) The debut video is now live on Mochi's official website: https://mochi.wafuu.com/ 1. About Mochi Mochi was born to embody the simple joy of choosing Japanese products. Its soft, rounded silhouette, gentle expression,
New NEURA Gym with RWTH Aachen: NEURA Robotics Expands its Global Training Network for Physical AI22.7.2026 09:10:00 CEST | Press release
NEURA Gym RWTH Aachen to open by end of 2026Ten NEURA Gyms under development, five operational by end of 2026 across Europe, the United States and ChinaIndustry partners gain access to the world’s first open infrastructure for training and deploying Physical AI NEURA Robotics ("NEURA"), the pioneer in cognitive robotics and creator of the Neuraverse, today announces a new partnership with RWTH Aachen University for the establishment of NEURA Gym RWTH Aachen. This continues the global rollout of NEURA Gyms, a worldwide network of purpose-built Physical AI training facilities that address the most significant barrier to intelligent robotics: the scarcity of real-world training data. The global rollout is backed by NEURA's Series C financing of up to $1.4 billion, the largest ever raised by a full-stack robotics company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721136838/en/ New NEURA Gym with RWTH Aachen: NEURA Roboti
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