Search Results for fda mobile health

Roundup: Virgin Pulse, NextGen close fast; Elucid, Eleos, Vida, Neteera funding; One Medical-CommonSpirit; Indian Health $2.5B EHR to General Dynamics+Oracle; losses, layoffs at Cano Health, 15% digital cuts at Mass General Brigham

...July, 20 June] in this Diagnosing Health Care Podcast of 10 November. Fun estimate: the time in filing a premerger notification may be increased by 289%. The cloudy crystal ball was clear indeed…. Last week was also a busy time for smaller companies’ fundings–even letter rounds! Elucid scored $80 million in Series C funding led by led by Elevage Medical Technologies, bringing total funding for this AI-assisted cardiovascular imaging company. They have the “only FDA-cleared non-invasive tool able to accurately characterize arterial plaque, simulating what pathologists would see under a microscope and establishing a histologic ground truth. The company is... Continue Reading

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

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... Continue Reading

Get your goggles on! Augmented and virtual reality finally taking off, from alleviating child pain to astronaut mental health

Augmented and virtual reality (AR, VR) back at last. A few years ago, the future of everything from rehabilitation to PTSD was going to be headsets/goggles and captivating programming. Alas, it went sideways. Now a revival is taking place: The Smileyscope VR platform from Australia recently received the very first Class II FDA clearance for acute pain and anxiety reduction via VR. In September, they received clearance for temporary relief of acute anxiety associated with needle procedures. Using what they term “virtual reality neuromodulation”. their Procedural Choreography technique uses positive virtual stimuli and substitution–for example, replacing a negative real-world stimuli... Continue Reading

Short takes: follow up on Cano Health’s survival moves, eMed transitioning Babylon Health UK but Babyl Rwanda shuts, DEA extends telehealth prescribing for controlled substances thru 2024

...further public news. And when you can’t decide, extend. The Drug Enforcement Administration (DEA) and Health and Human Services (HHS) once again are extending Covid-time flexibilities for prescribing controlled substances through 2024. After 38,000 comments on the proposed changes to rules after the last extension in May, DEA and HHS punted again on reimposing Ryan-Haight Act restrictions that would require in-person evaluations/visits prior to prescribing. This allows clinicians to prescribe Schedule II–V controlled medications via audio-video telemedicine encounters, including Schedule III–V narcotic controlled medications approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management treatment of opioid... Continue Reading

Two studies: telehealth’s ‘generation gap’ and $22B target for healthcare generative AI–by 2032

J.D. Power notices that older users aren’t all that comfortable with telehealth. On a 1,000 point scale, pre-boomers (!) and Boomers, score a 671 while Gen Y and Gen Z score 714 for an average of 698. Those surveyed liked telehealth for convenience (28%) and receiving care quickly (17%). Issues for the older group are trust, digital channels, and appointment scheduling. The latter two are, in this Editor’s view, interface related, with many telehealth providers neglecting mobile and tablet-friendly platforms, making typefaces large enough, and backgrounds contrasty enough. CVS leads in satisfaction, surprisingly, in direct to consumer telehealth providers (744),... Continue Reading

Could DocGo be another Babylon Health or Theranos? CEO resignation may be only the start of their troubles.

Another ‘fake it till you make it’ healthcare enterprise? Only a short month ago, things were fair and warmer for DocGo. They had recently transitioned from a mobile Covid-19 testing company under various contracts back to their original purpose–a telehealth/RPM, mobile urgent care, disease management, and medical transportation provider, with mobile vans covering the NYC metro. Founded in 2015 by Stan Vashovsky, now chairman, new CEO Anthony ‘Al’ Capone had successfully leveraged their mobility into a $425 million no-bid contract with New York City to provide medical services and more for over 19,000 migrants flooding into the city and being... Continue Reading

Short takes: FTC’s Lina Khan’s vendetta on tech, employers disillusioned with virtual care, telepsychiatry cuts LOS and inpatient ED, Lotte’s AI-assisted telepsych diagnostics, ThymeCare’s $60M Series B

...for diagnosing neuropsychiatric disorders like Alzheimer’s disease that Lotte will integrate into their mobile health app, Cazzle. Cazzle then creates personalized health recommendations for users. The South Korean market is unusual in that the rate for accessing mental health services is only about 1/10th of the population, yet mental illness is growing. Mobihealthnews To end on a positive funding note, ThymeCare scored $60 million in a Series B round. This was led by Town Hall Ventures and Foresite Capital with participation from existing investors Andreessen Horowitz Bio + Health, AlleyCorp, Casdin Capital, and Frist Cressey Ventures. ThymeCare is a platform... Continue Reading

Mid-week roundup: Babylon Rwanda update, CVS Health laying off 1,700+, Optum laying off too, Veradigm’s third non-compliance Nasdaq notice, AireHealth auctioning assets, Viome’s $86M raise + CVS retail kit deal

...announced the launch of its Gut Intelligence Test in 200 CVS locations. Online, the Gut Test retails for $149 on current sale. Viome also markets oral and throat tests plus a ‘full body’ test in the $200+ range. The gut test is not currently FDA-cleared, though its saliva-based oral and throat cancer test received FDA breakthrough device designation in 2021. They claim that its RNA sequencing technology that utilizes AI and advanced algorithms to analyze the world’s largest gene expression data from over 600,000 samples, was originally developed out of research from the Los Alamos National Laboratory, “is clinically validated,... Continue Reading

Mid-week short takes: Amwell lowers 2023 outlook, DocGo goes up, Imprivata + PFH win Ireland HSE contract, Oracle Health’s Nashville move, layoffs at 23andMe, Doximity

...to payer and provider migrations to their new platform, Converge, which will consolidate its offerings plus third-party tools, in a process that is losing providers and reducing visits. Release, Healthcare Dive DocGo, a telehealth and medical transportation provider, upped its outlooks. First, they reported a tidy bump in Q2 revenue of $125.5 million, up from $109.5 million in prior year. Once known for mass Covid testing which has largely disappeared, which was $28 million in Q2 2022, non-testing revenue grew 53% versus prior year. Revenue is split between transportation ($45 million) and mobile health ($80 million). Adjusted EBITDA was $9.1... Continue Reading

Thursday short takes: Fold Health VBC $6M round, Vivalink’s RPM in Burma rural health, Vytalize adds two to board, layoffs at TytoCare, IntelyCare

...suite of medical wearables including a multi-function ECG patch, is part of a rural healthcare initiative on the border of Thailand and Burma. They have donated multiple sets of the rechargable ECG monitor which pairs with a real-time patient monitoring mobile app that can operate ‘off the grid’ in what appears to be a store and forward mode. It is lightweight and small at 7.5 grams in weight and 3.5 inches in length. In this remote area, clinicians can use the ECG patch to monitor patients in the preoperative assessment area, during the surgical procedure under sedation, and during the... Continue Reading