Short takes: Dexcom G7 now directly connects to Apple Watch, Brightside Health acquires Lionrock, Aktiia CALFREE gains CE Mark for optical BP monitoring not requiring calibration

June 13, 2024 | by

Further consolidation in telemental health–and digital health device improvements.

The Dexcom G7 CGM now connects directly to the Apple Watch. The wearable Dexcom sensor will now send information direct to the user’s Watch without the iPhone intermediary, which makes it very convenient for users. According to Dexcom’s statement, the Bluetooth capabilities built into the system were designed to communicate blood glucose readings to multiple display devices  simultaneously and independently. The Dexcom connectivity to the Apple Watch will be available in the US, UK, and Ireland, to launch in additional markets later this month. One wonders when they’ll expand to non-Apple watches. The G7 sensor remains a prescription item, unlike the OTC Stelo which received FDA clearance in March with a launch later this summer [TTA 12 Mar]. Mobihealthnews

Telemental health provider Brightside acquires Lionrock Recovery, expands into substance use disorder therapy. Brightside, which concentrates on providing virtual psychiatric and therapeutic treatments for anxiety and depression, adds virtual intensive outpatient programs (IOP) and outpatient addiction treatments (OP) for substance use disorder (SUD). Founded in 2010, Lionrock is accredited by the Joint Commission and takes a personalized approach to care, leveraging technology to provide therapeutic approaches for those struggling with alcohol and drug use. Participants in IOP attend individual and group therapy sessions, engage in evidence-based lessons, obtain psychiatric treatment and medication as needed, and have access to lab testing and additional peer support communities. No purchase price nor management transitions were disclosed. Back in March, Brightrock added $33 million of Series C funding. Release

Aktiia’s new non-calibration optical blood pressure monitoring system receives Europe CE Mark. Switzerland-headquartered Aktiia’s new CALFREE optical blood pressure (BP) monitoring system, using input from common optical sensors, is the first in their lineup that does not require prior calibration with a traditional BP cuff. Their earlier systems required monthly calibration. The Aktiia system works off data from optical sensors of the type used in smartphone cameras and smart watches. The business objective is integrating medical-grade blood pressure tracking not requiring BP cuff calibration into a wide range of consumer devices. Aktiia presently claims 70,000 customers in seven countries. It is not yet FDA cleared but their website for the US indicates that they are coming in 2025. Release, Mobihealthnews

Action on bad apps in the US – not yet in the UK/EU

February 24, 2015 | by

It is most encouraging to see that the FTC in the US has reached a settlement with two suppliers of “Melanoma Detection” apps: “In two separate cases, marketers of MelApp and Mole Detective have agreed to settlements that bar them from continuing to make such unsupported claims.” The FTC are pursuing actions against two other companies.

Echoing the requirements also of the EU’s Consumer Protection Directives as applied to health claims (notably the Misleading & Comparative Advertising Directive 2006/114EC), Jessica Rich, Director of the FTC’s Bureau of Consumer Protection said: “Truth in advertising laws apply in the mobile marketplace.” “App developers and marketers must have scientific evidence to support any health or disease claims that they make for their apps.”

Sadly, despite a number of exposures of ‘bad apps’ that we have previously covered, as yet no action (more…)

Well someone thinks telehealth is good news!

August 12, 2013 | by | 2 Comments

Medtronic has just announced a $200m takeover of Cardiocom, the telehealth device maker.  If you can get through the paywall, the WSJ article is here (updated link not paywalled–Ed. Donna). FierceMedical quotes Medtronic as saying that “At-home monitoring is a proven method of reducing the rates of hospital readmission…and that translates to savings for payers, providers and governments.” First area of joint working is expected to be heart failure. Recent US regulations on Medicare, and increasingly insurance payers, penalize hospitals for 30-day same-cause repeat admissions. Medtronic press release.

Editor Donna: The announcement of Medtronic’s (#4 in worldwide revenue) acquisition of Cardiocom (both Minnesota-based companies) created quite a stir in the US as Medtronic is a ‘traditional medical device’ company best known for its implantables: cardiac shunts, stents, heart valves, pacemakers, insulin pumps and interestingly, a wide range of neurostimulators for different conditions. Now with the acquisition of Cardiocom, Medtronic moves into the post-implant/post-discharge/post-diagnosis chronic condition management continuum– not only into telehealth via Cardiocom’s devices and hubs, but also their clinical and care management systems. $200 million in cold cash is a fair bet even though Medtronic’s market cap is north of $55 billion. Medtronic has to see the opportunity to make a bottom line difference to providers and payers. It is also reacting to a narrowing in its profitable core market–medical devices are now taxed, there have been recent product defect-related ‘scandals’ tarring the industry, and there is pressure to reduce pricey device costs to fit a cost-constrained environment, driven by the new healthcare ‘scheme’ (in both the British and American English senses!) Forbes‘ David Shaywitz has a smart take on it today (though he won’t hold his breath for the pharmas to follow), as well as VC TripleTree’s Chris Hoffman ‘connecting the dots’ and coming up with what we’ve been talking about for some time–integration making sense. It is also most definitely a shot over the bow for major competitors such as Alere, Bosch and Philips plus a raft of smaller companies which have been working with a scattering of hospital discharge areas, integrated delivery systems, ACOs and home health agencies, looking nervously over their shoulder–and other leading medical device companies such as Stryker, BD, Baxter and yes….GE. (Bosch also sued Cardiocom on patent infringement this time last year [TTA 7 Aug 2012]; presumably as this suit was not announced as settled or decided, Bosch is now dealing with a company its own size!)

It also should be noted that Medtronic’s CEO, Omar Ishrak, is well acquainted with home health. Mr. Ishrak was formerly the CEO and president of GE Healthcare through mid-2011–and the driver behind making what was an ultimately failed bet in getting GEHC into home health. That was in 2008-9 with a tiny company called Living Independently Group, developer of a telecare system called QuietCare, which ultimately went to the Care Innovations JV with Intel. (Disclosure: I was head of marketing at the time of the acquisition.) Like GEHC, Medtronic is acquiring a closely-held company in a very different line of business with drivers quite unlike its own; they are retaining the former CEO as a general manager of the division but whether other management or the brand name will survive is not disclosed.

Whilst on the subject of telehealth devices, Heartwire reports a meta-analysis of 52 studies that shows that just measuring your blood pressure regularly results in a significant reduction in both systolic and diastolic levels after six months. Sadly the paper itself in the latest issue of the Annals of Internal Medicine is behind a paywall so it’s not possible to try to understand how the final comment in the synopsis of the paper on the Annals website that: “Additional support enhances the BP-lowering effect.” fits with the comment in Heartwire that “Low-strength” evidence from 13 studies comparing self-monitoring plus additional support vs self-monitoring alone “failed to support a difference” between the two strategies.”

Meanwhile back in the UK, Medvivo has become the first company to be accredited to the telehealth elements of the TSA’s Integrated Code of Practice. Sadly the TSA website will only release the Code to members (TTA isn’t one) or those aspiring to achieve accreditation (TTA fails on that one too) so it’s not possible to make meaningful comment. However the prospect of a Battle of the Codes is looking up with word from Malcolm Fisk that the final version of the European Code of Practice for Telehealth Services will be available for all to read and download on the TeleSCoPE website within a month. There has been talk of a third code being developed too…