...the implant was reported on 1 February. Ars Technica discusses a salient point, which is ethics around reporting a medical study via, in this case, social media, and by the company founder. It is not the way that research is conventionally conducted especially at an early stage. Ars quotes two bioethics professors who wrote a brief essay on this published by the Hastings Center. The PRIME study took only quadriplegic volunteers and the study received a go-ahead from the FDA for this early feasibility study. The money quote: “When the person paying for a human experiment with a huge financial... Continue Reading
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Facing the Music of the New Reality: Amazon Pharmacy & One Medical restructure; Walgreens shakes up health exec suites again, cashes out $992M in Cencora; new takes on NeueHealth; Cue Health, Nomad Health layoffs
...FDA approval for its 20-minute molecular test kits to supply the US government, the NBA, Google, and other large companies. Cue IPO’d in September 2021 at $200 million and $16/share, with a valuation of $3 billion. Its shares on Nasdaq are today at $0.25. The company also offers a test for mpox (monkeypox) and is seeking FDA approval for its RSV and Flu test kits. San Diego Union-Tribune New York City-based Nomad Health, a healthcare staffing service that took advantage of the pandemic demand for travel nurses but had not fully transitioned into other temporary healthcare workers, released 17% of... Continue Reading
Short takes: Orion digital pain therapeutic to be commercialized by Newel Health; Verma to head Oracle Health; CVS to shut 25 LA-area MinuteClinics
Orion Health licenses its chronic pain therapeutic to Newel Health. Orion’s ODD-533 (Rohkea), classified by FDA and the EU MDR as software as a medical device (MDSW or SaMD) will be developed, manufactured, and commercialized by Newel. Newel, located in Salerno, Italy, designs and commercializes digital medicine and digital therapeutics (DTx) for the US and EU such as Soturi, a digital therapeutic app for Parkinson’s Disease [TTA 23 Feb 23], Orion, located in Espoo, Finland, develops primarily human and animal pharmaceutical products. Orion release Oracle wastes no time in finding a new Oracle Health head, Seema Verma. Conveniently in-house, the... Continue Reading
News roundup: Musk’s Neuralink implants first human BCI; Cigna’s $3.7B MA sale to HCSC; no Amazon deal for iRobot; DispatchHealth-Instacart food Rx; 5 India health tech fundings (updated)
...recruited last fall after the FDA approved proceeding with a clinical trial. A blog post on the Neuralink website recruited adult volunteers with quadriplegia–paralysis of the arms and legs caused by a cervical spinal cord injury or amyotrophic lateral sclerosis (ALS). Earlier, Neuralink raised $280 million in a Series D led by Founders Fund. FierceBiotech 8 Aug 2023 There were difficulties, however. Within the past two years, Reuters reported 1,500 animal deaths over four years of research that attracted the attention of the Department of Transportation (DOT) (!) and the Department of Agriculture’s inspector general. FDA held up approval of... Continue Reading
Midweek updates: Walgreens may sell Shields Health after 2 years; Ventric Health’s home cardiac RPM; Singapore military medical corps upgrades PACES 3 EMR
...failure is a major disease, with 6.5 million in the US diagnosed and joined by 550,000 every year. Ventric Health has a newly FDA-cleared non-invasive cardiac diagnostic system for remote patient monitoring (RPM) that can be used in the home as well as clinical settings. A trained clinician can use Ventric’s Vivio system to perform an evaluation in the home or a clinic that could only previously be done in the hospital. An EKG patch and arm cuff are placed on the patient, connected to a tablet with the Vivio app and its advanced algorithms via Bluetooth, and in under... Continue Reading
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
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... Continue Reading
A timely webinar Fri 12 Jan: Protecting a lifeline – preparing for the digital voice switchover (UK)
...of the “big switch”. Telegraph (via Yahoo Finance Canada) More about Silver Voices’ campaign to delay the switchover of traditional copper wire landlines to internet-based telephone systems (VoIP or Digital Voice). VoIP is far more versatile but not as reliable as copper (although when copper fails…). Everyone with internet knows the loss of voice and device connectivity when it goes out and how battery backup systems are short-lived at best, if there at all. Cellular/mobile can be used as backup, but many areas of the UK are without reliable cell coverage–which can also fail in storms. Hat tip to Adrian... Continue Reading
News roundup: ONC recommends ‘nutrition labeling’ for healthcare AI apps but Google moves forward; CVS’ health services rebranding as Healthspire (updated); Clover Health repots out of ACO REACH
...lung cancer detection, a tool for diagnosing diabetic retinopathy, and a question-answering bot. Google makes no secret that they plan to influence Federal efforts at setting standards by hiring lobbyists, most of whom are out of the Food and Drug Administration (FDA), and playing a large role in industry groups such as the Coalition for Health AI (CHAI). If you believe that Google, Microsoft, Amazon (playing catchup), or other healthcare service companies like UnitedHealth Group’s Optum will twiddle their thumbs and wait for the Feds to set standards and (good grief) enforce disclosure on AI tools, this Editor has several... Continue Reading
Has Amazon lost its ‘edge’ in healthcare? Or finally seeing reality?
...employers. TTA 6 Jan 2021 Then there was the brief and mysterious life of Amazon Care, 2019-2022. Their mix of virtual care, in-home, and telehealth services signed up large employers such as Hilton and (of course) Amazon with the eventual vision of delivering in-home care of visits and medications via mobile providers. Despite plenty of pivoting behind the scrim but eventually going nationwide with some, not all, of their services, their vision wasn’t attractive to most large employers. Even before One Medical was acquired in July 2022, Amazon decided to ditch Care by end of 2022. TTA 25 Aug 2022... Continue Reading
Perspectives: The Impact of Virtual Nursing on Telehealth
TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion area. Today’s contribution is from Donna Gudmestad, MHL, BSN, RN, CCRN-K, who is clinical program manager and clinical product owner of mobile technology for Caregility, which provides secure, reliable, and HIPAA-compliant audio and video communication designed for any device and clinical workflow, in both acute and ambulatory settings supporting 1,300+ hospitals across dozens of health systems. Ms. Gudmestad has 30+ years of nursing experience and 14+ years of telemedicine operational and implementation experience. Prior to Caregility, she served as a bedside clinician, clinical manager, director... Continue Reading
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