Belfast’s B-Secur obtains FDA 510(k) clearance for HeartKey ECG/EKG algorithm library

February 6, 2021 | by

A Belfast (NI) biometrics startup, B-Secur, on Thursday announced FDA clearance of its ECG/EKG software library that analyzes individual heartbeats and heart rhythms, which can be implemented across a wide range of health and wellness monitoring devices.

B-Secur received FDA clearance for the following algorithms part of HeartKey ECG/EKG: Signal Conditioning, Heart Rate, and Arrhythmia Analysis, which includes Atrial Fibrillation, Bradycardia and Tachycardia.

According to their release, the algorithms can be integrated into semiconductors for a broad range of devices, enabling rapid integration of medical-grade ECG/EKG software. It also can run embedded on devices, on the application layer, and via the cloud into systems. As a turnkey solution, it can speed the development of new devices or upgrade older types. By upgrading the monitoring capabilities of health and wellness devices, it can extend clinical-grade monitoring out of the clinic or hospital in less obtrusive ways, which is extremely useful for diagnosing transient cardiac conditions such as atrial fibrillation. 

Not yet cleared are HeartKey algorithms for heart rate variability (HRV), energy expenditure, and physiological stress. There is also a UserID feature that uses an individual’s ECG/EKG to personalize and protect that person’s physiological data. 

B-Secur has raised £11.5 million in multiple venture and one Series A round since its founding in 2002 and in its current iteration in 2014 (Crunchbase).

Rounding up September’s start: AliveCor’s hyperkalemia detector, Apple’s ECG Watch, Tunstall Nordic’s EWII, steps towards a bionic eye, Philips licenses BATDOK, VistA’s international future

September 13, 2018 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/12/Lasso.jpg” thumb_width=”120″ /]AliveCor gets a fast track for its bloodless hyperkalemia (high blood potassium) detector through the FDA Breakthrough Device program. Working with doctors at the Mayo Clinic, they developed a way to read patterns in electrocardiograms (ECG/EKG) that track increasing potassium levels without drawing blood. While attributed in the CNBC article to AI, it seems closer to machine learning. Hyperkalemia is a condition that is seen in type 1 diabetes, chronic kidney disease, and other kidney related conditions. The device and software is at least one year away from approval including a clinical trial, even on this program which further speeds up the Expedited Access Pathways (EAP) program under the 21st Century Cures legislation. AliveCor currently markets the Kardia Band that reads ECGs.

Meanwhile, the Series 4 iteration of the Apple Watch moves further into the medical device area–and AliveCor’s ECG niche–with a built-in atrial fibrillation-detecting algorithm and an ECG, along with fall detection via the new accelerometer and gyroscope. The Apple Watch will start shipping September 21. Mobihealthnews.

Danish energy and broadband provider EWII has sold its subsidiary EWII Telecare A/S to Tunstall Nordic. EWII Telecare provides telemedicine and telehealth services on a tablet platform dubbed Netcare (video here). The EWII Telecare website is already down. Telecompaper, Tunstall Nordic release

Foundational technology for a bionic eye? The University of Minnesota has developed a method using 3D printing to create light receptors on a hemispherical surface. Printing a base of silver ink, the next layer was photodiodes of a semiconducting polymer which convert light into electricity. ZDNet

Philips Healthcare is licensing the Battlefield Airmen Trauma Distributed Observation Kit (BATDOK) technology for remote monitoring of vital signs by combat paramedics. Terms were not disclosed. BATDOK was developed by the US Air Force Research Laboratory, which sought commercialization. [TTA 6 Sept 17]  Mobihealthnews

What is generally not known about the VA’s eventually departing EHR is that it has for some years an open source version called OSEHRA VistA. Plan VI will expand VistA capability by making it compatible with different languages using Unicode and creating a reference implementation for global use. Working with non-profit OSEHRA are research groups in South Korea, China, and the Kingdom of Jordan. Release

Apple’s patent on camera plus sensors for health measurements

August 19, 2017 | by

9 to 5 Mac, the tip sheet for all things Apple, tracked down a patent granted to Apple (via Patently Apple) for computing health measurements using the iPhone. According to Apple in the patent, “electrical measurements may be used to measure heart function, compute an electrocardiogram, compute a galvanic skin response that may be indicative of emotional state and/or other physiological condition, and/or compute other health data such as body fat, or blood pressure.” It would use the front-facing camera, light sensor and proximity sensor to emit light that would be reflected back to the sensors. Additional sensors mounted in the same area would also generate additional health measurements such as body fat and EKG, which is already measured by the Kardia Mobile/Alivecor attachment. The camera and light sensor alone, based on the patent and the article, would measure oxygen saturation, pulse rate, perfusion index and a photoplethysmogram (which can monitor breathing rate and detect circulatory conditions like hypovolemia). Another demonstration of Apple’s keen interest in the health field, but what features will show up on real phones and apps–and when?