News roundup: Owlet’s Dream Sock, BabySat go to market; General Catalyst’s HATco agrees to buy Summa; Cigna’s contrasting provider strategy; new ElliQ robot assistant debuts at CES

January 18, 2024 | by

JP Morgan’s Healthcare Conference (JPM) and CES are as expected big generators of news around digital health–here’s a selection from then and more:

Owlet launches Dream Sock and BabySat at CES. Both were FDA-cleared in November and June 2023 respectively. The Dream Sock baby monitor received first-of-kind de novo clearance for pulse oximetry and sends real-time Health Notifications for low pulse rate, high pulse rate, and low oxygen to parents’ smartphones. Target market is infants 1-18 months and 6 to 30 pounds with direct sale on the Owlet website at $299.

The BabySat is the prescription-only version (left) targeted to infants 1-18 months and 6-30 pounds, but with acute or chronic medical conditions. It also has the unique capability not only to track vital signs but also for the provider to customize alarms for oxygen saturation and pulse rate. Owlet’s BabySat information page explains in plain English the type of medical conditions where the BabySat would be of assistance and the steps to obtain a prescription that is fulfilled through their partner AdaptHealth. A virtual Rx and insurance reimbursement are in the works. A small drawback is that it is only usable with an iPhone. Happily, their stock is also on the rebound at the highest point in six months. Having followed them since the ‘telehealth for the bassinet set’ days of 2012-2013, their continued independence, their rebound from some dark days, as well as their focus on baby health, this Editor continues to wish them bonne chance. Owlet release (via Yahoo Finance).

Big Investor General Catalyst announced their first acquisition move for the Health Assurance Transformation Corporation (HATCo) not at JPM but today (17 Jan). Summa Health is a $1.8 billion (in revenue) non-profit integrated healthcare system headquartered in Akron, Ohio that encompasses hospitals, community medical centers, a health plan, an accountable care organization, a multi-specialty physician organization, medical education, research and the Summa Health Foundation. HATCo’s objective is to transform healthcare towards a goal of “health assurance”, defined as “a more affordable, accessible and proactive system of care” where presumably their extensive experience in investing in healthcare gives them expertise. [TTA 10 Oct 2023] The letter of intent initially sets up a partnership with immediate investment in Summa while due diligence takes place, then when completed moves to a definitive agreement with details of the acquisition and a transaction price in the next few months. Summa would move from a non-profit to a for-profit in becoming a subsidiary of HATCo. According to their information, current management will remain in place.

Summa’s incentive is to stem losses, reportedly at $37 million through Q3 2023, more than double the prior year. HATCo in November stated its desire to buy a health system in Summa’s $1 to $3 billion range. As usual, the buy is subject to regulatory approvals and a final closing date.  HATCo release, Summa Health statement on “our future”, FierceHealthcare

To the contrary, Cigna prefers to partner, not own, healthcare providers. As a payer closer by many degrees to hospitals and practices than General Catalyst, structured much like UnitedHealth Group with Evernorth its counterpart to Optum, they have avoided the aggressive ownership of physician practices. UHG employs about 10%–90,000–physicians through ownership of practices as of December 2023. MedPageToday  At JPM, Cigna CEO Eric Palmer emphasized ‘strategic relationships’ like a minority share of VillageMD (majority owned by Walgreens) in their acquisition of Summit Health, and creating an ‘ecosystem’ that connects to the best partners. Their investments will be wrap-around services in home health, behavioral and virtual care now that a merger with Humana is once again off the table. Becker’s Payer They’ll have some cash to do so; Cigna’s sale of their Medicare Advantage business will likely be to Health Care Service Corporation (HCSC) and fetch $3 to $4 billion. Becker’s Payer

Intuition Robotics debuts ElliQ 3 at CES. An interactive desktop companion robot designed to improve social connection and alleviate loneliness of older adults and those with assistive needs, the new version updates the robot hardware and software capabilities including generative AI capabilities powered by Large Language Model (LLM). The new design from Yves Behar’s design studio, Fuseproject, is also 1.3 pounds lighter and has a 36% smaller footprint which makes it easier to both place and handle, along with a fully integrated screen. Technical improvements include an octa-core SoC and a built-in AI processing unit (APU); 33% more RAM, twice the amount of computing power and memory, and an inclusion of a dual-core AI processing unit (APU), all of which are needed to power generative AI for greater ‘conversant’ capabilities. The LLM technology integrated into the Relationship Orchestration Engine makes real-time decisions regarding actions, scripted conversation, and generative AI conversations. For instance, the person speaking with ElliQ may talk about activities and beliefs, which are stored and classified. In another conversation, ElliQ may use that information to suggest participation in activities and social interactions, while ensuring that the context and flow of conversation is ‘guardrailed’ and appropriate. The AI can also assist the person in activities such as painting or writing poems together.

Current partners include the New York State Office for the Aging, Inclusa (a Humana company), and the Area Agency on Aging of Broward County, as well as newer partners like The Olympic Area Agency on Aging, Ypsilanti Meals on Wheels, and others. Release

Israel-based Intuition Robotics most recently raised $25 million in August 2023 in an unlettered round with $20 million in venture capital plus $5 million in venture debt. TTA 19 Sept 2023

Short takes: Owlet Dream Sock FDA clearance; Best Buy-Mass General partner for at-home care; Amazon offers Prime members deeper One Medical discount

November 10, 2023 | by

Some really good news for Owlet. The Dream Sock finally got to the mountain top and received de novo FDA clearance for pulse oximetry. To date, it is the only over-the-counter medical pulse oximetry device for the baby market. This adds to the device’s Baby’s Live Health Readings, including pulse rate and oxygen saturation level. The platform also provides Health Notifications, which send alerts to a smartphone with lights and alarm sounds if baby’s readings fall outside of preset ranges. Existing and new Dream Sock buyers will be upgraded to the new features by end of 2023. The Dream Sock is for use with infants 1-18 months and 6 to 30 pounds. Pricing observed for the current Dream Sock is in the $300 range. Owlet release

This follows FDA clearance for the prescription BabySat in June [TTA 21 June]. That is scheduled to be introduced later this year in the US only. The non-prescription Dream Duo, which combines the Dream Sock with a baby cam, will continue to be sold. 

Financially, things have improved a lot since last year. The stock as of 11 July was restored to NYSE listing, but it required a reverse split and an 18 month compliance plan, Currently, it’s trading at about $4.80 which is NYSE compliant, up from well below $1 in June. Also in July, they hired a new president and chief revenue officer, Jonathan Harris, from recently acquired air purification system Molekule. In August, they reported a Q2 adjusted EBITDA loss of $4.3 million, narrowed substantially from prior year Q2’s $16.7 million. This was achieved on lower revenue of $13.1 million versus last year’s $18.3 million. Q1 revenue was $10.7 million. Q3 will be reported on 13 November. Release  Having followed them since the ‘telehealth for the bassinet set’ days of 2012-2013, their continued independence, and their focus on baby health, this Editor continues to wish them bonne chance.

Mass General Brigham’s hospital-to-home and home care programs get a Best Buy boost. Mass General plans to integrate Best Buy’s delivery capabilities for their Healthcare at Home program in several areas. For Home Hospital acute care, Best Buy will supply the Current Health remote patient monitoring program to build out a technology-enabled clinical delivery model that connects patients to nurses, paramedics, advanced practitioners, and physicians. For Home Care, Best Buy will supply Lively Mobile Plus personal emergency response system (PERS) and leverage out capabilities such as Geek Squad to supply Mass General Brigham (MGB) patients with delivery of home-based care and logistics management for the care team. MGB plans to introduce Best Buy as part of Home Hospital in five Boston-area acute care hospitals. The program is for patients with heart disease, chronic obstructive pulmonary disease (COPD) and infections. While their Home Care operation is stated by MGB to be the largest certified provider in New England, the Home Hospital program can presently cover only 33 patients at a time. MGB’s goal is to shift 10% of inpatient care to patients’ homes over the next five years, so expanding capacity and capabilities are critical. FierceHealthcare, Mobihealthnews, MGB release

Get your One Medical now, just $99 per year or $9 a month! It’s an offer hard to refuse for Amazon Prime members. It’s half off the annual membership of $199, with additional members up to five for only $6 a month or $66 annually. What Prime members get is 24/7 virtual care access without further charge through their app that includes video chats with licensed providers plus their “Treat Me Now” service, fast care for common issues like cold and flu, skin issues, allergies, and urinary tract infections. It does not include any One Medical in-office services, if available in the member’s area. The 200 million+ Prime members were briefly offered in February a $144 membership but apparently this new incentive is not only at a deeper discount, but also longer term or permanent.

Time to make that $3.9 billion acquisition pay off. This push is clearly to build up One Medical membership, which stood at only 836,000 members at end of 2022, and build up cash flow. Amazon is not reporting on the success of the earlier discount offer. A question this Editor has–if 1 million Prime members signed up–that’s only a 0.5% rate–does One Medical have the telehealth capacity to serve these patients, especially at peak usage such as cold and flu season?

Prime members are also able to access Amazon Care, which is virtual only, cash-only by medical event asynchronous telehealth services. If a Prime member goes in person to a One Medical practice, they do take insurance. FierceHealthcare, Healthcare Dive, Amazon Prime offer page

Owlet sock pulled from US distribution after FDA warning letter

December 4, 2021 | by

Awwww turning to Owwwww! High-flying Owlet has lost some altitude due to the consequences of a 5 October FDA warning letter. The outcome, at least for now, is that Owlet cannot sell its Smart Sock in the US. The Smart Sock measures sleep patterns, blood oxygen saturation, and pulse rate through pulse oximetry. FDA is now considering it a medical device that falls under 510(k) marketing clearance requirements, including premarket approval (PMA). Effective 22 November, the Owlet app will no longer be downloadable, although current owners who have downloaded the app for the Smart Sock and the Cam will not be affected. There are Owlets in the reseller pipeline, such as Amazon, which have now been rendered non-working. The Owlet Smart Sock can be sold outside the US, but not from the website.

What is surprising from the FDA letter is that they have had this issue with Owlet for five years. From the letter: “Since 2016, the FDA has corresponded with Owlet that the Owlet Smart Sock meets the definition of a device under the FD&C Act and does not fall under the compliance policy for low-risk products that promote a healthy lifestyle (General Wellness guidance).” The latter is a catch-all that has enabled various tech products to go to market with statements such as “not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition”. It may have been either an escalation of monitoring capabilities, of marketing, or of the FDA deciding after the SPAC that Owlet needed to be treated differently. Owlet came to market in 2013.

Owlet’s letter to customers alludes to the FDA warning letter and that no safety issues were raised. They promise here and on the website that they will “transition to a new app and consumer wellness product that addresses FDA’s concerns”. The website continues to sell the Owlet Cam and Dream Lab, with ‘Coming Soon’ in January for the new Dream Sock and Dream Duo, but with no details. What’s not known are any details on their capabilities, whether they will fall under ‘general wellness’, and whether Owlet has begun the laborious and long process of filing as (likely) a Class II device.

Owlet enjoyed a SPAC during the summer [TTA 23 July] that nabbed it $135 million and a valuation of over $1 billion. It traded then at $8. Today’s close was $3.95. Its market cap is now less than half. It’s disappointing to this Editor that Owlet didn’t file with FDA well before the SPAC. They now have the opportunity to get FDA clearance, but the more likely outcome is that, at least for now, they will market a less capable device that falls under ‘general wellness’. Deseret News, FierceBiotech, CNET, The Verge

Short takes for a spring Friday: wounds, babies and ‘frequent fliers’

May 8, 2015 | by

Starting off your spring weekend….WoundMatrix, which uses generally older model smartphones to take pictures of wounds which are uploaded either to their own or to a destination clinical platform, with proprietary software that helps a clinician analyze the wound remotely and then to track healing progress, has gone international with Honduras’s La Entrada Medical and Dental facility run by non-profit Serving at the Crossroads, and in Rwanda in the care of nearly 1000 patients by the Rwanda Human Resources for Health Program, established by their Ministry of Health with the cooperation of several American universities. At ATA they also announced a new release of software. Release (PDF attached)….A BMJ (British Medical Journal) article critiquing the surge in what we call ‘telehealth for the bassinet set‘ scores the Mimo onesie (Rest Devices), the Owlet sock and the Sproutling band as taking advantage of concerned parents. It’s too much continuous monitoring of vital signs that can vary and yet be quite normal, and no published studies on benefit. A reviewer did find that Owlet is in clinical tests at Seattle Childrens and University of Arizona. MedPageToday (BMJ requires paid access)….A surprise from Philips, which we in the US associate with the Lifeline PERS. They have quietly moved into telehealth focusing on post-discharge programs that target the most costly patients, often dubbed ‘frequent fliers’ based on their frequent stays in hospital. The ‘Hospital to Home’ telehealth pilot with Banner Health in Arizona, dubbed for them the Intensive Ambulatory Care (IAC) program, focuses on the top 5 percent of complex patients which are the highest cost and most care intensive. IAC results among 135 patients over six months reduced hospitalizations by 45 percent, acute and long-term care costs decreased by 32 percent and overall cost of care by 27 percent. However, is this program continuing–or transitioning their patients?  iHealthBeat, PR Newswire

More telehealth for the bassinet set

May 22, 2014 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/12/3019806-poster-1280-sprouting.jpg” thumb_width=”160″ /][grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/08/product_sock-Owlet.png” thumb_width=”160″ /][grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/05/0ca96884.MimoKimono.png” thumb_width=”160″ /][grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/05/Sensible-baby.jpg” thumb_width=”160″ /]Industry talk is that wearables are no longer the hottest things on the hype curve because of smartwatches and smartphones getting even smarter, but one area is the exception: baby wearables. MedCityNews has an overview of four, three of which we’ve noted since late 2012: Sproutling, Owlet, Rest Devices’ Mimo Turtle (which fastens into Kimono, a/k/a the ‘onesie’) and (new to us) Sensible Baby SmartOne. All have some combination of heart rate, skin temperature, movement/sleep position monitoring from sensors into a smartphone app. Form factors: Sproutling and Owlet are anklets, Mimo Turtle’s monitor fits into a designated secure pocket in the lower (baby’s) left of the onesie, Sensible Baby goes into a pocket or attaches to clothing so it’s likely more suitable up to toddler age. Last December’s FastCompanyDesign article on Sproutling targeted its debut for this summer [TTA 10 Dec 13], but there’s no trace of a website so it’s still in development. Owlet’s been in market since fall 2013 [TTA 27 Aug 13] as has Mimo Turtle which is now sold through major retailer Babies ‘R’ Us.  Sensible Baby is still inviting beta testers and pre-orders at $99, projecting $149 when on sale later this year. There’s also no reassurance on the site that the SmartOne can be safely chewed — and of greater concern, its size appears to be small enough to swallow. With pricing between $150 and $300, they are at the Velocity of Cute as ‘ooh-ahh’ gifts for those baby showers which are coming up on many calendars and for your favorite Quantified Self Moms. (Just hold the obsessive smartphone checking.)

Also: Investor/engineering lab Lemnos Labs’ blog posting on Sproutling’s development from application/prototype to a scalable production model will be interesting especially if you are being challenged in the hardware development process.

Previously in TTA: Wearables on the hype cycle: a ‘Fitbit for babies’, Owlet baby monitor sock exceeds funding goal (But Huggies Tweet Pee seems to have stayed in Brasil…), Owlet baby monitor sock moving to market, Cute sensor fashions now for baby. 

Pacifying baby, taking temperature

March 26, 2014 | by | 2 Comments

UK developer BlueMaestro has announced a temperature-sensing baby pacifier with the somewhat obvious name Pacifi. According to Mobihealthnews (but frustratingly not on their website), the pacifier sends temperature data via Bluetooth Smart to an iPhone or Android app. Parents can record medication dosing and reminders, track temperature and medication over time, and set up an alarm when baby runs a high predetermined temperature. It’s also dishwasher safe. Pacifi joins Raiing Wireless‘ body thermometer FDA cleared in 2012 (now iThermometer) and Kinsa’s plug-in smart thermometer which took a crowdsourcing approach to local public health. It is not cleared for sale yet in the UK or US, but was shown at last month’s Mobile World Congress Barcelona and the Smart UK Project in London. Unfortunately, it may be a while before Quantified Self Moms can put it on the list for their baby showers, along with the Owlet monitoring sock, Mimo onesie and iTeddy [TTA 10 Sept]. Related: MedCityNews compares Mimo to adult sleep monitor Lark, awarding the matchup to Mimo. The real matchup is Owlet versus Mimo (see this Editor’s comment). (Also see our comments here discussing the safety of RF monitoring around babies.)

Owlet baby monitor sock exceeds funding goal

September 10, 2013 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/09/Owlet-closeup-small.jpg” thumb_width=”150″ /]In late August, we followed up on the major league cute ‘n’ useful Owlet monitoring sock and its effort to self-fund development. It’s now exceeded its $100,000 crowdfunding goal at over $121,000 with 721 pledged supporters. Along with this of course is the obligation to deliver products in November. What this points to is the appeal of a product addressing the powerful concern of baby wellness and sleep–a ‘job to be done’–and that it can be done outside of the usual East/West Coast accelerator, cocktail party and D3H hype loop in decidedly unfashionable, abstemious Utah. Congratulations in order! Website/pledge tracker.

There’s a bit of a boomlet in baby monitoring products, with Mobihealthnews lining up the Rest Devices’ Mimo onesie plus ‘turtle’ monitor, Croatia’s iDerma Teddy the Guardian teddy bear [TTA 22 July], Pixie Scientific’s Smart Diapers which not only detects wetting but also UTIs or kidney problems and the simpler Huggies Tweet Pee that alerts to changing (and reminds to buy diapers) which is in test in Brazil but reportedly will launch this month. Baby showers and their concomitant oohing and aahhing will never be the same. 6 baby activity trackers announced this summer

Owlet baby monitor sock moving to market

August 27, 2013 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/08/product_sock-Owlet.png” thumb_width=”150″ /]About nine months ago [TTA 6 Dec 12], the Owlet baby monitor in prototype won a student competition at Brigham Young University. It definitely ‘socked it” to this Editor at the time as an elegant way to monitor baby vital signs or signs of distress; it is a sensor-rich sock transmitting to a smartphone. While it still had pending patents, needed further prototyping and of course no FDA approval, I recommended “if you’re an angel looking for a highly marketable telehealth item–and with adult uses in hospitals and nursing homes–a trip to Utah may be in order.” Owlet is now seeking $100,000 in crowdfunding directly via its website and Amazon checkout (it was rejected by Kickstarter for being a baby product!) and will ship the device at an early bird rate of $159 once the funding is achieved. (more…)