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).
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2018/10/apple-watch-series-4-elektrokardiogram.jpg” thumb_width=”125″ /]Mid-September’s Apple Fans kvelled
about the Apple Watch Series 4 debut
. Much was made in the health tech press of Apple’s rapid FDA clearance and the symbolism of their further moves into medical devices with the Series 4 addition of a built-in atrial fibrillation-detecting algorithm and an ECG, along with fall detection via the new accelerometer and gyroscope.
This latter feature is significant to our Readers, but judging from Apple’s marketing and the press, hardly an appealing Unique Selling Proposition to the Apple FanBoys’n’Girls who tend to be about 35 or wannabe. The website touts the ECG as a performance feature, a ‘guardian and guru’ topping all the activity, working out, and kickboxing you’re doing. It positions the fall detection and Emergency SOS in the context of safety during or after hard working out or an accident. It then calls 911 (cellular), notifies your emergency contacts, sends your current location, and displays your Medical ID badge on the screen for emergency personnel, which may not endear its users to fire and police departments.
Laurie Orlov in her latest Age In Place Tech article points out the disconnect between the fall risk population of those aged 70+ and the disabled versus the actual propensity (and fisc) to buy an Apple Gizmo at $400+. PewInternet’s survey found that 46 percent of those over 65 actually own a smartphone, though this Editor believes that 1) much less than 50 percent are Apple and 2) most smartphone features beyond the basic remain a mystery to many. (Where store helpers, children, and grandchildren come in!)
Selling to older adults is obviously not the way that Apple is going, but there may be a subset of ‘young affluent old’ who want to sport an Apple Watch and also cover themselves for their cardiac or fall risk. (Or have children who buy it.) This is likely a sliver of a subset of the mobile PERS market, which is surprisingly small–only 20 percent of the total PERS market. But monitoring centers–doubtful, despite it being lucrative for GreatCall.
[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
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2018/02/Northwestern-stroke-patch.jpg” thumb_width=”150″ /]Is stroke avoidable?
We know it is an expensive medical event at $20-23,000 for hospitalization alone (NIH)
, which does not count rehabilitation or the devastation to individuals and their families, including loss of ability and work. NHS England
is testing two devices, the Kardia Mobile
and Watch BP
, with an eye to preventing stroke in those vulnerable to it. 6,000 devices are being distributed to GP practices in England in a program through 15 NHS and care innovation bodies known as Academic Health Science Networks (AHSNs)
. The Alivecor
‘s Kardia Mobile is a smartphone add-on clip that captures a medical-grade ECG in 30 seconds, stores, and sends readings to physicians. The application to stroke is primarily in atrial fibrillation (AF) and irregular heart rhythms, which according to statistics, more than 420,000 people across England have. Watch BP is a blood pressure cuff device which is also equipped with an AF detection system. The goal of the project is to identify 130,000 new cases of AF over two years, to prevent at least 3,650 strokes and potentially save 900 lives. Savings to NHS are being estimated at £81 million annually. Digital Health News
Post-stroke rehabilitation treatment is also being boosted by a new device developed at Northwestern University and being tested at the Shirley Ryan AbilityLab, a Chicago research hospital. It is a Band-Aid® like device which can be applied to key areas such as the throat (left above, credit AbilityLab), chest, or limbs to send back information to doctors on how a patient in treatment post-discharge, especially at home, progresses. The sensors and platform measure heart activity, muscle movement, sleep quality, swallowing ability, and patterns of speech. Especially revolutionary is the monitoring of speech communication and swallowing, which are often impaired in stroke patients but hard to track once the patient is out of a facility. The team’s research was presented last week at the American Association for the Advancement of Science (AAAS) annual meeting. New Atlas. Hat tip to Toni Bunting.
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?
AliveCor have today announced the Kardia Band which replaces the ordinary strap on an Apple Watch. Touch the band with your other hand and it records a one-lead ECG (EKG=US) that communicates with the Watch app, Kardia by AliveCor. The Atrial Fibrillation (AF) Detector then uses an algorithm to instantly detect and inform the wearer of the presence of AF, the most common cardiac arrhythmia and a leading cause of stroke. Other ‘detectors’ look at the ECG to determine normal heart rate and rhythm or if you should retake an ECG so physicians receive only the highest quality recordings.
Users can also record voice memos on their Apple Watch to accompany each ECG that give doctors and caregivers a clearer picture of what was happening at the time of the recording — describing symptoms such as palpitations or external factors like caffeine intake. Kardia also integrates seamlessly with Apple’s Health app to include ECG data with steps and calorie intake to provide richer, personal analysis over time.
A short note at the end indicates that the FDA-cleared AliveCor Mobile ECG, best known for snapping on to an iPhone but works on Android smartphones as well, has been rebranded as Kardia Mobile to establish a product family.
In the US, the Kardia Band is pending 510k clearance and is not currently for sale. Plans for the UK have not been formally announced but anticipated soon. AliveCor release.
Looking back over our predictions made on 31st December last year, it’s hard to quibble with any, and worth hanging on to those that didn’t come good this year.
Our first was
Security and data privacy issues will become a serious mHealth issue in 2014; developers failing to take great care over security and privacy issues will risk very adverse publicity and worse.
Job done: that certainly proved correct, with many being exposed as either selling or potentially selling private information. Clinicians were not immune from privacy invasion either. Here is a US summary of the issues. Attention was drawn to an EU Article 29 data protection opinion (actually published in 2013) that sought to clarify the legal framework applicable to the processing of personal data in the development, distribution and usage of apps on smart devices, and the obligations to take adequate security measures. Many apps got hacked too, including FDA-approved ones. There were also items, such as this one, demonstrating how complex the law is in this area in the US. In the EU, the arrival of the Data Protection Regulation in 2015 (now some say 2016) will undoubtedly improve data privacy significantly, though the failure to treat data used for health purposes differently from (more…)
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/04/skinpatch-1-John-Rogers.jpg” thumb_width=”150″ /] From the head researcher (John Rogers at the University of Illinois at Urbana-Champaign) who brought you biodegradable implanted batteries and sensors [TTA 26 March], comes an almost tattoo-like stretchable sensor conforming to the skin which uses off-the-shelf, chip-based electronics for wireless monitoring. It is envisioned for wireless health tracking connecting to smartphones and computers, and for vital monitoring such as ECG and EEG testing, although this Editor would not use the term ‘clinical’ as Gizmodo has done (it is probably at the fairly sound level of an AliveCor.) However the article points out the advantages in long term use–adherence to skin is far more reliable, no dangling pendants or clunky bracelets, and it allows for multiple sensors to be worn comfortably. This type of patch would also be far kinder to the delicate skin of babies and the elderly. For them, it would make consistent long-term telehealth monitoring (e.g. blood pressure, ECG, O2, blood glucose) far easier over time. Perhaps the core of this is the PERS of the future with gait tracking and fall detection. Cost isn’t mentioned, but off the shelf elements undoubtedly are less expensive than custom/bespoke. Published in Science 4 April (abstract and summary; full text requires log in) Also see Editor Charles’ earlier take–maybe Mr. Rogers should speak to him!
A year-long pilot program in Australia to screen for for atrial fibrillation (AF) found new, previously undiagnosed AF in 1.5% of those tested. The SEARCH-AF study used the AliveCor Heart Monitor ECG to test 1,000 customers 65 years and older through community screening in suburban Sydney pharmacies. Pharmacists used the AliveCor device, attached to an iPhone, to transmit 30-60 second ECG recordings to study cardiologists. If AF was suspected, the follow-up was a GP review and a 12-lead ECG performed. AF is the most common heart rhythm abnormality and puts an individual at five times the risk for stroke (National Stroke Association). Early diagnosis and treatment cost savings are straightforward: over $20,000 (~£12,400) for prevention of one stroke. (This Editor’s opinion–it’s an understatement.) Per the study summary:
The incremental cost-effectiveness ratio of extending iECG screening into the community, based on 55% warfarin prescription adherence, would be $AUD5,988 (€3,142; $USD4,066) per Quality Adjusted Life Year gained and $AUD30,481 (€15,993; $USD20,695) for preventing one stroke. (“Feasibility and cost effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies”, Thrombosis and Haemostasis, Ben Freedman, MD et al., 1 April online (subscription access required for full study)
15 new AF diagnoses per 1,000 may not sound high, but using the above estimate, this type of community screening using AliveCor or a similar device translates to a cost saving of over $310,425, assuming that all undiagnosed AF resulted in a stroke. Even if less, it is a nice return on investment, health and future outcomes. (This Editor invites more accurate cost analysis.) AliveCor release (San Francisco Business Times). Additional coverage CNet Australia. The George Institute for Global Health Australia project page which extends the study to GP clinics.
Breathlessly noted in today’s mHealth blogosphere is AliveCor’s partnership announcement with EHR giant Practice Fusion to integrate their patient-generated ECG information. According to the release, the 100,000 physician base of Practice Fusion will have the option to import AliveCor ECG data into patient records. This is a major breakthrough for AliveCor, which just gained FDA over-the-counter clearance for its snap-on case [TTA 11 Feb]. The AliveECG app also enables physicians to obtain an expert review of the ECG data, annotate and electronically transfer this data into the EHR within seconds. Is this the confirmation that AliveCor is the ‘product of the year’ as the Forbes article puts it? Or just an indicator where mHealth with clinical quality could be going? (Let’s see if other EHRs like Athenahealth join the trend.) Release
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/02/aerotel-heartview-p128-mobile-feb14.jpg” thumb_width=”150″ /]For those attending GSMA Mobile World Congress
in Barcelona next week and interested in how a more traditional telehealth provider incorporates mobile technology, stroll over to the Israeli Pavilion (Hall 5, Booth #5C81) to see Aerotel
‘s new (debuted at Medica Dusseldorf last November) HeartView P12/8 Mobile, an extension of their existing 12-lead ECG line that incorporates a 3G module for patient data transmission to either a call center or to a physician’s email. Aerotel claims that it is the smallest and most accurate 12-lead mobile monitor on the market. We thank Boaz Babai of ARPU~UP, Aerotel’s marketing agency, for the heads-up–but it would have been helpful to have a link to the (nonexistent?) product web page. Release (finance.yahoo.com).
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/02/s4_case.jpg” thumb_width=”150″ /]AliveCor Inc., the developer of the AliveCor mobile heart monitor, announced today the granting of over-the-counter (OTC) clearance for the device. It is a single-channel ECG ‘case’ that snaps on to iPhones and Android phones to record, display, store and transfer data into the AliveCor application where it can be transmitted to doctors or in the US, to a US-based board-certified cardiologist or cardiac technician in a new analysis program called AliveInsights. US residents can pre-order now with shipments starting in March for $199. It is already available for the UK and Ireland through AmazonUK at £169. Release PDF