Business Wire

B-Secur Receives FDA Regulatory Clearance For Its HeartKey® EKG/ECG Technology

Share

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 atJersey 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)

Contact information

United States
Cecilia Zhong
The Hoffman Agency for B-Secur
Tel: +1 408-975-3003
Email: bsecur@hoffman.com

United Kingdom
Shona Jago-Curtis/Corinna Keenan/Calum McCullough, Jago
Email: shona@jagocommunications.com or corinna@jagocommunications.com
Tel: +44 28 909 18420

About Business Wire

Business Wire
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

C3 AI to Present at FIS Securities, Derivatives and Tax Processing Virtual Event9.3.2021 12:00:00 CETPress release

C3 AI (NYSE: AI), a leading enterprise AI software provider, today announced that its President and Chief Product Officer Houman Behzadi will present at FIS’s Securities, Derivatives and Tax Processing Virtual Event on March 9, 2021. Mr. Behzadi will join a Thought Leadership panel focused on the application of cutting-edge technology, such as machine learning, artificial intelligence, and automation, to capital markets. Panel Details: Conference: FIS Securities, Derivatives and Tax Processing Virtual Event Title: Thought Leadership: Applying Cutting Edge Tech to Capital Markets Date: Tuesday, March 9 Time: 8:55-10:00am EST Event Link: https://gateway.on24.com/wcc/experience/eliteFidelityInformationServi2/2303154/3036161/securities-derivatives-tax-virtual-event About C3.ai, Inc. C3.ai, Inc. (NYSE:AI) is a leading provider of Enterprise AI software for accelerating digital transformation. C3 AI delivers a family of fully integrated products: C3 AI® Suite, an end-to-end platform for deve

American Express Launches 2021 Global Travel Trends Report9.3.2021 12:00:00 CETPress release

American Express (NYSE: AXP) released the American Express Travel: Global Travel Trends Report today, which provides unique insight into consumer sentiment toward travel nearly one year after the COVID-19 pandemic began. The findings in the report, grounded in survey research across seven countries, including the United States, Australia, India, Canada, Mexico, Japan and the United Kingdom1, demonstrates that consumers are looking forward to traveling again and that they are planning for future trips. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210309005322/en/ American Express Travel: Global Travel Trends Report Finds Consumers are Looking Forward to Traveling Again (Graphic: Business Wire) Top insights include: Strong Pent-Up Demand for Travel: 87% of people surveyed said that having a trip planned in the future gives them something to look forward to, 76% of respondents are creating their destination wish list for futu

Scoro Raises $16 Million in Series B Funding To Invest In Its End-to-End Work Management Software9.3.2021 11:00:00 CETPress release

Scoro, an award-winning work management software for professional service businesses, has closed a $16.4 million Series B funding round led by Kennet Partners. Additional investors include Columbia Lake Partners, Inventure, Livonia Partners and Tera Ventures. The investment will fuel continued global expansion and is supported by new French and Spanish versions of the software. “Even before Covid-19 hit, most professional service businesses used as many as a dozen different platforms daily,” said Scoro’s Founder and CEO, Fred Krieger. “However, teams now realise that constantly switching between tools harms productivity and results in lost data and duplicated work. In many ways, these tools became weapons of mass distraction. We’re proud to have the support of Kennet Partners and other investors as we help businesses identify and remove these weapons of mass distraction with our end-to-end work management software.” Scoro's most recent product launch has been a modernization of the Gan

1010data Partners with Strategix CFT to Enhance the Value of Retailer Data and Expand European Coverage9.3.2021 11:00:00 CETPress release

1010data, a provider of analytical intelligence and data sharing solutions to the retail, consumer goods and financial services markets, and Strategix CFT, a boutique consulting company that specializes in innovative retail technologies and comprehensive systems integration, announced today that they have entered into a strategic partnership to provide offerings that deliver enhanced customer insights. Targeted at Retailers and Consumer Packaged Goods (CPG) companies across the UK and Europe, the two companies will use their combined resources to develop analytics solutions that deliver the fastest predictive and prescriptive customer insights. The new partnership will provide advanced data analytics technology driving best practices for large retailers to optimize and grow their business in this fast-changing market environment. This will include a single, powerful source of data enabling collaborative planning between retailers and suppliers. A single, integrated analytics platform e

XPRIZE and Cognizant Announce Grand Prize Winners in Pandemic Response Challenge to Restart Economies Around the World9.3.2021 09:31:00 CETPress release

XPRIZE, the world’s leader in designing and operating incentive competitions to solve humanity’s grand challenges, in partnership with Cognizant(Nasdaq: CTSH), one of the world's leading technology and professional services companies, today announced the Grand Prize Winners in the $500K Pandemic Response Challenge. The four-month global competition was designed to harness the power of data and artificial intelligence in equipping policymakers, health officials and business leaders with the insights and guidance necessary to implement public safety measures that help keep local economies open while minimizing virus outbreaks as vaccines become more widely available. These decision-makers are encouraged to use the results, methodologies and technology from the challenge as reference on approaches to minimize potential outbreaks, now and moving forward. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210309005419/en/ Winning fir

The NAGA Group AG Closes USD 30 Million Financing Framework and Reports Record Growth9.3.2021 09:23:00 CETPress release

The NAGA Group AG (XETRA: N4G, ISIN: DE000A161NR7), provider of the social network for financial market trading NAGA.com, reports on the largest financing arrangement in the company's history to date and further record growth in February 2021. NAGA has signed an agreement with the US Fund Yorkville Advisors securing a growth financing framework of up to USD 30 million. "We are excited about the deal with Yorkville and are setting the course for NAGA to scale even faster. The financing gives us the power and the flexibility to allow the company to be taken to the next level. NAGA is a growth case in a very large and rapidly growing market. This decade will be definitely the breakthrough period for FinTechs", comments NAGA CEO Benjamin Bilski on the closed deal. In addition, the company reports on preliminary results for February which have once again significantly exceeded the record figures from January 2021. In February, NAGA achieved a record user growth with 37,000 new accounts and

Fibocom Announces Multiple Next-Gen 5G NR Modules to 3GPP R16 Standard at MWC Shanghai 20219.3.2021 05:15:00 CETPress release

Fibocom (Stock Code: 300638), a leading provider of cellular embedded wireless module solutions for the Internet of Things (IoT), announced the world-wide launch of the next generation 5G NR modules compliant with the 3GPP R16 standard during Mobile World Congress Shanghai 2021 (MWCS21). The new launch includes FM160 and FG160 5G module series of Sub-6GHz frequency range, as well as FM160W and FG160W series of mmWave range. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210308005973/en/ Fibocom Next-Gen 5G Modules (Photo: Fibocom) Product video on YouTube: https://www.youtube.com/watch?v=Wg0nE1WtoBM The new 5G NR module series is based on the newly-announced Qualcomm® Snapdragon™ X65 and X62 5G Modem-RF Systems and delivers enhanced mobile broadband and high-reliability, low-latency wireless services for IIoT (Industrial IoT), FWA ( Fixed Wireless Access), 4K/8K live streaming, telemedicine, private 5G networks, and other ma

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