News roundup: AliveCor’s latest FDA clearance plus antitrust vs. Apple, VRI on the market, Walgreens’ ‘tech-enabled future’ indefinite plus VillageMD status, monthly telehealth usage drops 12.5%

AliveCor disclosed its latest FDA 510(k) clearance for the KardiaMobile 6L, for calculation of patients’ QTc interval by the patient remotely or in the office with a physician or other clinician. QTc interval is, for those of us who aren’t cardiologists, is the total time from ventricular depolarization to complete repolarization. If too long (prolongation) or too short (congenital short) for the heart rate, it can indicate a dangerous ventricular arrhythmia or atrial or ventricular fibrillation. The manual measurement takes 30 seconds. AliveCor also has clearance on software (InstantQT) that measures QT intervals quickly and accurately to detect potentially dangerous QT prolongations in patients. Prolongations can be triggered by medications including anti-arrythmia drugs, anti-fungals, antibiotics, and some psychiatric drugs. AliveCor release. In other recent news, in June they acquired CardioLabs, a monitoring and cardiac diagnostic service provider based in Tennessee, to expand their clinical servies. Release.  

And in David Sues Goliath–Again–News, AliveCor also filed, in that quiet week right before Memorial Day, a Federal antitrust suit in the Northern District of California. This lawsuit is over Apple’s exclusion of other heartrate analysis providers from the Apple Watch, harming AliveCor and consumers, and seeks damages plus an injunction to cease the exclusion. Release  This is in addition to their US International Trade Commission (ITC) complaint on infringement of AliveCor patents held for heart monitoring on the Apple Watch 4, 5, and 6. That seeks to bar importation of Apple Watches [TTA 29 Apr]. No update on that so far. 

‘Insider’ report: VRI on the market. PERS Insider, our newly discovered source for news about the emergency response device market, reported on 22 June that VRI, a PERS and remote patient monitoring provider, is up for sale. It has been majority-owned by Pamlico Capital, a private equity company, since 2014. VRI does not sell direct to consumer but concentrates on health insurance, government programs, and other B2B through its dealer network. No reasons for sale given, but with all things telehealth and most things remote healthtech fetching hefty sums post-pandemic, perhaps Pamlico senses a fortuitous time to test the waters for an exit. Article. (Subscribe here to their weekly free letter)

Walgreens Boots Alliance’s new CEO promises a ‘tech-enabled’ future for the chain, sans details. The incoming CEO, Rosalind Brewer, fresh from her COO position at Starbucks, on WBA’s Q3 earnings call mentioned a buildout of a “previously communicated tech-enabled healthcare initiative” but no further information, as still reviewing the company. Stefano Pessina has retired from the long-held CEO position, but retains the executive chair title in addition to being WBA’s largest individual shareholder. Forbes’ breathless report. More to the profit point, the latest on Walgreens and VillageMD’s full-service Village Medical practices at Walgreens locations: 29 new locations in Houston, Austin and El Paso, Texas this year, staying on track for 600 primary care practices in more than 30 markets over next four years. Business Wire

National telehealth usage dips to 4.9% of US claims in April, a 12.5% drop from March. Analyzing regional and national insurance claims data, non-profit health analytics company FAIR Health in its monthly report tracks telehealth receding as patients return to in-person care. Telehealth is now dominated by mental health procedure codes, accounting for 58.65% of diagnoses, with all other conditions at 3% or lower. Regionally, the Northeast is even higher at 64.2% and the Midwest above 69%. Monthly National report, Monthly Regional Tracker page

David sues Goliath: AliveCor claims patent infringement by Apple–ITC filing requests bar on Apple Watch US importation

Slingshot battle! AliveCor, developer of the Kardia Mobile electrocardiogram (ECG) and connected heart rhythm devices, filed a complaint with the US International Trade Commission (ITC) alleging Apple’s infringement of three AliveCor ECG technology patents for the Apple Watch 4, 5, and 6. The filing seeks to bar the importation of Apple Watches into the US and their sale.

According to AliveCor’s carefully worded release, their filing in the ITC “is one step, among others, AliveCor is taking to obtain relief for Apple’s intentional copying of AliveCor’s patented technology—including the ability to take an ECG reading on the Apple Watch, and to perform heartrate analysis—as well as Apple’s efforts to eliminate AliveCor as competition in the heartrate analysis market for the Apple Watch.”

This follows on the first shoe–AliveCor’s December lawsuit, filed in the US District Court for the Western District of Texas, alleging that the Apple Watch 4, 5, and 6 infringed on the same patents. The timing was interesting, as FDA cleared the latest update of the Apple Watch’s ECG monitoring at about the same time [TTA 10 Dec 2020]. In November, AliveCor cleared a Series E of $65 million.

The irony is that in 2017, the KardiaBand was the first FDA-cleared medical device accessory for Apple Watch. It was an ECG-reader that clipped onto the watch. AliveCor pulled it from the market after Apple introduced its own ECG feature in the Apple Watch 4.

AliveCor has their entire business riding on this. The mass-market Kardia Mobile, their six-lead medical-grade KardiaMobile 6L, and their KardiaCare platform with monitoring and evaluations are their business, unlike Apple for which ECG is only a feature.  Mobihealthnews, FierceHealthcare, MDDIOnline

After the COVID Deluge: a Topol-esque view of what (tele)medicine will look like

A typically cheery view by Eric Topol, MD of what medical practice will look like after COVID is over. With the full court press to go remote in hospitals and practices worldwide, telehealth and telemedicine has gone fast forward in a matter of under two months. But what will it look like after it’s over? Most of what the good doctor is prognosticating will be familiar to our Readers who’ve followed him for years–certainly he was right on mobile health overall and especially AliveCor/Kardia Mobile— but not so on point with mobile body scanners (anyone remember VScan?)

When the high tide recedes, what will the beach look like?

  • “Telemedicine will play the role of the first consultation, akin to the house-call of yore.” (Terminology note–interesting that Dr. T still uses ‘telemedicine’ versus ‘telehealth’–Ed.)
  • Chatbots will serve as screeners–once they are proven to be effective (a ways to go here, as the Babylon debate rages on)
  • Smartphones will be the hub, connecting with all sorts of monitoring devices (the ‘connected health’ Tyto Care and Vivify Health model–which makes the Editor’s former company, the late Viterion Digital Health, even more of a pioneer that died crossing the Donner Pass of 2016)
  • Smartwatches are also part of this hub (this Editor remains a skeptic) 
  • Now is the time to harness technology by both health systems and individual practices, but multiple barriers remain. (This Editor can speak to the difficulties for both primary care and specialty practices in not only practice but also reimbursement–and acceptance by patients.) Device expense is also a problem for the non-affluent.

As to the rest, it is pretty much what we’ve heard from Dr. T before.  The Economist

Your Editor will add:

  • Easy to use, secure platforms that don’t put users through multiple security steps remain a concern for users. This Editor’s concern is that easy to use = insecure. Skype and Zoom are inherently insecure–Skype’s user unfriendliness and insecurity outside enterprise platforms and Zoom’s major security problems on its platform and user flaws are well-known (ZDNet).
  • Reimbursement, again! CMS has done a creditable job in broadening reimbursement for telehealth a/v and telephonic services, but coding remains a nightmare for practices struggling to remain open and with some lights on. After COVID, will CMS and HHS get religion, or put it right back in its rural bottle? Covered in the CARES Act passed at the close of March, $200 million sounds like a lot from the FCC to bankroll telecom equipment for providers, but these funds will go quickly. At least they are not delayed in endless rule making, as the Connected Care Pilot Program has been for two years. Mobihealthnews 

News, events roundup: FDA clears AliveCor’s first 6 lead ECG, Jawbone Health rises from ashes, Let’s Get Checked’s $30M check, Health Wildcatters’ $35M ‘how to’ breakfast

AliveCor receives FDA clearance for KardiaMobile 6L, the first FDA-cleared personal 6-lead device. From the AliveCor release, the description: “In addition to the two electrodes on the top of the device, there is one additional electrode on the bottom. The user places her thumbs on each of the two top electrodes, and places the bottom electrode on her left knee or ankle. This formation, known in cardiology as the Einthoven Triangle, allows cardiologists to view electrical activity in the heart from six perspectives or “leads.”” The information is sent to the mobile device’s software including KardiaAI bradycardia and tachycardia detection features cleared recently for the single-lead KardiaBand, as well as deeper information into arrhythmias. The single-lead ECG space that AliveCor pioneered with first their snap-on then the KardiaBand is now crowded with the Apple Watch, Withings, and numerous others. It’s a big step forward for the company. AliveCor has opened pre-orders now at $149, to be delivered starting in June. Hat tip to co-founder Dr. Dave Albert. 9to5Mac, Biospace (release), Mobihealthnews

Save Your Jawbones, the Founder Rises Again. Yes, Jawbone founder Hosain Rahman just raised $64.5 million for a new company. The new outfit, dubbed Jawbone Health, will offer a “personalized subscription service where we take all of this continuous health data about you and we combine that with a lot of machine intelligence . . .” to prevent avoidable diseases. After having burnt to a crisp $1 billion over 10 years on wireless speakers and fitness bands, again Mr. Rahman goes into territory which isn’t exactly unique with the footprints of the aforementioned Apple Watches, Withings, Spry Health’s Loop, EarlySense, etc. But hey,  SignalFire and Refactor Capital in the Bay Area, Polymath Ventures and Meraas in Dubai like his style. Even TechCrunch is arching an eyebrow.

Let’s Get Checked checks in with $30 million raise. This NYC-based direct-to-home supplier and manufacturer of in-home test kits raised a $30 million Series B from Leerink Transformation Partners, Qiming Venture Partners USA, and Optum Ventures after last year’s $10 million Series A. Customers can order in-state physician-approved laboratory tests via LetsGetChecked.com or through partner retailers, including CVS, Walmart, Pharmaca, and McKesson online stores, with delivery in 1-2 days. Tests covering wellness, men’s and women’s health are processed by CLIA-certified reference labs with results sent to a secure online account in 2-5 days, with the customer referred to in-state physicians for interpretation of results and further action if needed. PrivaPath Diagnostics markets in the US, Canada, Ireland, and Europe. Release

Speaking of raising money, how about $35 million for your med device startup? Health Wildcatters is hosting one of their Pulse Health Startup Education Series breakfasts (7.30-9am) in Dallas on Tuesday 21 May with main speaker Ken Nelson from Bardy Diagnostics, which just had a $35.5 million Series B, presumably letting everyone in on the secret. Registration and more information here.