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
AIM Expands Life Sciences Supply Chain Capabilities and Hires New Partner, Thomas Ebel1.6.2026 15:01:00 CEST | Press release
AIM today announced the appointment of veteran pharma supply chain expert Thomas Ebel as Partner, effective June 15. Mr. Ebel brings more than 25 years of supply chain consulting experience at leading firms including CAMELOT, McKinsey, and Accenture, and will anchor a broader initiative to expand AIM’s end-to-end supply chain capabilities. According to Richard de Bakker, Statutory Director and Founder at AIM, the firm is significantly expanding its capabilities around “end-to-end” supply chain needs. “AIM is well known as a leader in supply chain development for launch, as well as optimization of existing supply chains — supporting clients in getting their finished products to patients,” said Mr. de Bakker. “We are now adding new capabilities in supply chain diagnostics and strategy, end-to-end planning optimization, supply reliability, and working capital optimization, among others. Combined with AIM’s established supply chain expertise, this expanded offering gives clients true ‘end-
Seoul Semiconductor's World-First 'HV Opto-Semiconductor' Powers Up Global Top 4 Automakers1.6.2026 15:00:00 CEST | Press release
Seoul Semiconductor Co., Ltd. (KOSDAQ: 046890), a global opto-semiconductor technology company, announced that its world's first High Voltage (HV) opto-semiconductor technology has entered mass production with four of the world's top automotive brands across the Americas, Europe, and Asia, with plans to expand supply to 10 models by the end of the year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260601232986/en/ Comparison: Conventional 3V LED vs. Seoul Semiconductor 12V 'HV Opto-Semiconductor' (Figure: Seoul Semiconductor) The technology combines micro-scaled opto-semiconductor chips capable of 12V single-chip operation — as opposed to conventional 3V LEDs — with a high-voltage (HV) driver technology. This enables a reduction of more than 10% in the number of driver-related components used in hybrid and electric vehicles, while lowering power consumption by approximately 10%, contributing to cost reduction and simplific
Oscilloquartz delivers assured timing for mission-critical harsh environments with ruggedSync™ Series OSA 55101.6.2026 14:00:00 CEST | Press release
News summary: Defense operations require resilient timing architectures that maintain synchronization in contested and GNSS-denied environments ruggedSync™ Series OSA 5510 delivers assured timing and extended holdover in a MIL-qualified platform for tactical, deployable operations Zero-trust resiliency with diversified cPNT sources, including M-Code, PRS and STL, strengthens operational continuity for defense communications, navigation and mission-critical infrastructure Oscilloquartz today launched its ruggedSync™ Series OSA 5510, a ruggedized timing and synchronization platform engineered for defense and other harsh, mission-critical environments. Designed for deployment in tactical communications networks, mobile command centers (MCCs), aviation systems and other highly demanding operational environments, the OSA 5510 combines PTP grandmaster and NTP server functionality with synchronization assurance and resilient holdover in a compact MIL-qualified platform. Multi-band GNSS suppor
Vertex Announces US FDA Acceptance of Biologics License Application for Accelerated Approval of Povetacicept in IgA Nephropathy1.6.2026 14:00:00 CEST | Press release
- FDA assigns Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026 – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) submission for povetacicept, an investigational engineered fusion protein and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, in adults with immunoglobulin A nephropathy (IgAN). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026. If approved, povetacicept will become the first commercialized therapy in Vertex’s emerging nephrology franchise. “The Phase 3 RAINIER trial is the largest conducted in IgAN and achieved full enrollment faster than any contemporary IgAN trial, reflecting the significant unmet need in IgAN and our urgency to bring povetacicept to patients with this serious disease,” said Nia Tatsis, Ph.D., Executi
Winston Taylor Completes Historic Transatlantic Combination1.6.2026 13:01:00 CEST | Press release
Transatlantic powerhouse law firm established for the businesses, people, and markets driving capital and innovation Winston Taylor announces today that Winston & Strawn and Taylor Wessing’s U.K.-led business have officially launched as a single combined firm, creating a premier transatlantic law firm built for the needs of the businesses, people, and markets driving capital and innovation. One of the largest transatlantic firms, with more than 1,400 lawyers spanning the United States, the United Kingdom, Europe, Latin America, and the Middle East, Winston Taylor is built to meet clients’ evolving global needs for counsel. “As Winston Taylor, we are centered on a client-first approach and will be working shoulder to shoulder with our clients at the cutting edge of industry and ingenuity,” said Chairman Steve D’Amore. “With that common purpose, we are leveraging both strength and scale by integrating our teams and offices at record speed, working at pace to create a firm that is aligned
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