Midjourney Medical audaciously promises a revolution in whole-body scanning, powered by Butterfly Network chips. Can the reality ever match the hype?

Editor’s Note: I am indebted to Stuart Miller of Haverin on Substack for the initial and later follow up (linked below)  articles on this, plus our exchanges. Feel free to read his first essay first and return here for a further discussion of both Midjourney Medical and Butterfly Network, plus his second article referenced in Part 2.

Part 1: Midjourney Medical and the Prototype Scanner

Can the reality match the hype that’s jumped the rails? Midjourney Medical is a new company (or division) that grew out of Midjourney, a organization claiming to be a “community-funded lab of 60 people known for building the most beautiful AI models in the world”. Moving past the breathless prose, Midjourney Medical has developed a prototype of a whole-body scanner that, unlike present CT scanners and MRIs, does two major things: it fully scans the body in a minute and there is no radiation. The methodology is almost Star Trek-ian: your body is lowered gently into a circular tank of warm water, and 40 chips arrayed in a ring generate waves that change shape when they meet parts of your body (e.g. from skin to fat to muscle to bone).  The waves generated by the chips are translated into  ultrasound computed tomography (USCT) creating a 3D map of a human body, with the completion goal at 60 seconds of scanning and computing time.

This is coming from a 1st generation prototype. The images in the announcement video are supposedly not AI-generated but actual from about a dozen subjects. The actual timing is about 20 minutes at present, a real time not in the announcement but in articles (see below), and the subjects were uniformly slim.

Yet it’s audacious as all get-out, in a time drowning with incrementalism and no Big Next Thing.

If the results from the prototype are real and the timeline/vision are achievable, the potential is stunning. Being lowered briefly into a tank of water is a far more pleasant experience than the tube and noise of an MRI, though for claustrophobics or just those afraid of being submerged in water, the fears are similar. If taken to its logical development, it could, in fact, threaten the business of nearly all of the mainline MRI/CT scan companies such as GE Healthcare, Philips, Siemens, and Canon if it is medically validated and gains FDA clearance.

As Stuart Miller pointed out and described well in his article, there is already an FDA-cleared water/sensor array for USCT used as a diagnostic adjunct for dense breast mammography–SoftVue, developed by Delphinus Medical Technologies of Novi, Michigan. So there is precedent, one already in place and accepted in mainstream medical practice. A device that every woman would accept as standard instead of current.

However, breast scanning does not go through bone (e.g. ribs) nor gas (lungs), which is USCT’s drawback. At present, when ultrasound is used, a trained technician has to work the device between the ribs a millimeter at a time to gain an unblocked view, not in 60 seconds but taking 60 minutes or more.

Midjourney Health’s ambitions are wellness, not medical grade, at least into 2028. The announcement states that this prototype is the first of three.

  • Their roadmap is that by end of 2027, Midjourney’s will open a 24/7 medical spa in San Francisco, with the 2nd generation prototypes providing detailed body composition maps for clients, accumulating data for its own case, scanner development, and yes, FDA.
  • 2028 would introduce a 3rd generation scanner with custom chips and a ‘night-and-day’ change in image quality and scan times.
  • The trajectory is opening proprietary medical spas, staying within ‘general wellness’ permitted by FDA, and gaining acceptance of the technology.
  • Ultimately, by 2031, the plan is “to have a fleet of over 50,000 scanners worldwide – with a total scanning capacity of a billion scans a month”. The rationale: early imaging without symptoms>>change in lifestyle>>avoidance of 30% of deaths and 50% of healthcare costs.

Mr. Miller’s skepticism in his article is well presented and warranted. He details that ultrasound can’t go through bone and gas, dunking has psychological and physical drawbacks such as consistently clean water, the ability to run spas at scale, the business drawbacks of no reimbursement, no billing codes, no FDA validation. Unless it is priced well, the Midjourney vision of a pop-in spa and wellness checks  will be confined to the early adopters and the affluent curious privately paying up to thousands of dollars for the experience, much as whole-body MRIs, also in the ‘general wellness’ category away from FDA scrutiny, are today. Can spas support 50,000 scanners? Not likely.

It all sounds rather vague and glossy in a song that this Editor has heard before in the digital health (IBM Watson Health circa 2012) and concierge practice areas.

What is also scarce in this announcement is that once you have this information, what do you do with it? Is it conclusive enough to take to a physician and do follow up?  Or if lifestyle, will these spas affiliate with clinicians who can do the counseling? From the Forbes article on the announcement:

“Whole-body screening of people with no symptoms turns up incidental findings in 20% to 40% of scans, yet only a small fraction ever require treatment, as University of Michigan radiologists have noted. At a billion scans a month, even modest rates imply hundreds of millions of ambiguous results a year, each one demanding a clinical decision and producing a worried customer.”

In the category of ‘it does what it says it does”–a must in generating credibility for a new technology–false positives or even ambiguity are killers.

Since Midjourney Medical is a separate community-backed research lab, they are seeking support from the ‘community’ and not, at this point, explicitly seeking investors. There are reports that the company generates hundreds of millions of dollars in annual recurring revenue, according to Mobihealthnews. Their substantial funding needed for development, chips, and spas has to come from somewhere, and this vagueness about their funding disturbs this Editor.

What Midjourney Medical has in spades is strong skills in generating press coverage. Besides Stuart Miller’s Substack article on 19 June, Mobihealthnews published their take the same day, along with a wave of articles over the next ten days from Radiology Business to Fox News’ Cyberguy to Futurism. The Verge’s 23 June critique proved to be a lengthy deflation. While it presented Midjourney’s side by interviewing their head of medical Tom Calloway, the bulk of the article consisted of far more critical comments from several imaging and radiology professionals. Matthew Davenport, a professor of radiology at the University of Michigan Medical School, said that (FTA) published images were “interesting” and that he could see a market for body imaging. But the company’s “claims are wildly unsubstantiated, perhaps the most grandiose” he has seen. William Morrison, a radiology professor at Thomas Jefferson University, was downright scathing calling it a “vibe-based rollout” and (FTA) that the whole move, he said, has the feel of an ad campaign. “It makes me think that this may be more of a grift than a pivot.” Words like “grandiose” and “grift” tend to stick. 

Part 2: Butterfly Network, Their Chips, and the Agreement with Midjourney

Midjourney Medical had a partner in this which, interestingly, was not mentioned in the announcement. Our Readers may be familiar with the name Butterfly Network. (more…)

Early news roundup: Envision exits Ch. 11, splits; Walgreens’ new CIO; Philips’ $60M from Gates Foundation; more on Walmart-Orlando Health partnership; Cigna may sell MA business

Staffing firm Envision Healthcare exits Chapter 11 bankruptcy, splits off AmSurg clinics. One of the Big Bankruptcies earlier this year has been reorganized, cutting $8 billion in debt by 70% and spinning off its AmSurg surgical clinics to new ownership. The hospital and physician staffing company was hurt as early as 2020 with shortages of available staff, then the pandemic which cut patient volumes, and conflicts with payers around out-of-network billing charges. The last put the company in conflict with the ‘no surprises’ patient protection billing law that took effect this year. One particular legal spat with UnitedHealthcare tied up both companies for years, but was won by Envision after an independent arbitration panel this past spring awarded Envision $91 million, finding that UHC breached its in-network contract. KKR, which had taken Envision private in 2018, lost $3.5 billion in equity, one of their largest corporate investment losses. Henry Howe, the company’s chief financial officer, takes over as interim CEO on 1 December as current CEO Jim Rechtin leaves to join Humana. Healthcare Dive  Background: TTA 12 May, 16 May   

Walgreens fills its chief information officer vacancy with the interim CIO. Neal Sample was appointed last Wednesday (1 Nov) as CIO and EVP, reporting to new CEO Tim Wentworth and joining the executive and IT governance committees. Sample was appointed last month as an IT advisor after CIO Hsiao Wang left suddenly on 2 October. Both Wentworth and Sample worked with each other at Express Scripts, with Sample holding both COO and CIO positions there, then departing for the CIO position at Northwestern Mutual. Walgreens release, Retail Dive

Philips receives an additional $44 million from the Gates Foundation for further Lumify Ultrasound System development. The total of $60 million in grants starting in 2021 was for the development of AI-enabled applications to improve obstetric care in low- and middle-income countries. The Lumify handheld ultrasound system assists frontline health workers, such as midwives, in interpreting obstetric images and identifying possible complications during pregnancy in hours versus weeks of training. The system’s Kenya trial was successful. The additional funding will be used to expand global adoption in underserved rural communities. Philips release  This follows Gates Foundation grants to GE Healthcare ($44 million) and Butterfly Network ($5 million) for easily deployed ultrasound and imaging systems to support low-income countries’ rural maternal health and respiratory scanning. Mobihealthnews

More on Orlando Health’s partnership with Walmart. Briefly noted here last week in Walmart’s release and reporting on Walmart Health’s new partnership with Centene’s Ambetter plan in Florida was the Orlando Health hospital partnership. This will coordinate care for patients admitted to the health system’s hospitals or who need specialty care. It is a first for Walmart as it has not previously partnered with local health systems on specialty and hospital care as an extension of its clinics. Eight of its 48 clinics are in the Orlando area. Becker’s Health IT 1 Nov, 6 Nov

Cigna is exploring a sale of its Medicare Advantage (MA) business. According to the exclusive report by Reuters (may be paywalled), Cigna is in early stages, at this point consulting with an investment bank. Cigna is not much of a player in the difficult state-by-state, county-by-county MA business, with 599,000 members as of 30 September, which is about 3% of their 19 million total insurance members. But it has been problematic, with Cigna recently paying CMS $172 million to settle allegations that it violated the False Claims Act by submitting incorrect data to obtain higher payments. By comparison, UnitedHealthcare and Humana have nearly half (47% or 14.5 million) of the national 30.8 million MA members (KFF). Becker’s

Mid-week roundup: Promising Langone AI/LLM predicts hospital readmits; Huma gains FDA 510(k) Class II clearance; telepsychiatry’s challenges; layoffs/asset buys/losses from 23andMe, Cityblock, Thirty Madison, Butterfly

New York University’s Langone Health’s large language model (LLM) accurately predicting hospital readmissions, more. NYU’s academic medical center NYU Langone Health has developed an LLM using medical language, NYUTron, from unstructured clinical notes in patient records, then fine-tuned it across a wide range of clinical and operational predictive tasks. The dataset was immense:  ‘NYU Notes’ covers 7.25 million clinical notes (for example, radiographic reads, history, and physicals) from 387,144 patients across four hospitals, and more. According to their study published in Nature on 7 June, it was tested for predictive ability in five areas: 30-day all-cause readmissions, in-hospital mortality, comorbidity index, length of stay, and insurance denial. The NYUTron system in testing has achieved results improved over conventional structured models’ baselines. From the Nature study:

  • For 30-day readmission prediction, it had a median area under the curve (AUC) of 79.9% ± 0.168% with a 5.36% improvement
  • On in-hospital mortality prediction, NYUTron had a median AUC of 94.9% ± 0.168% with a 7.43% improvement.
  • On comorbidity index imputation, NYUTron had an OVR median AUC of 89.4% ± 0.275%
  • On binned LOS prediction, NYUTron had a median AUC of 78.7% ± 0.179% with a 12.3% improvement 
  • On insurance denial prediction, NYUTron had a median AUC of 87.2% ± 0.246% with a 14.7% improvement.

In a test of the system during January-April 2022, the system analyzed 29,286 discharged encounters, with 3,271 patients (11.17%) returning within 30 days. NYUTron predicted 2,692 of the 3,271 readmissions (82.30% recall) with 20.58% precision. Also HealthcareITNews

London-based Huma (the former Medopad) gained US FDA 510(k) Class II clearance for their Software as a Medical Device (SaMD) platform. This is defined as disease and age-agnostic digital health pathways through which data are collected from patients for self-management or to be assessed remotely by healthcare professionals. Huma also recently obtained EU MDR Class IIb approval and with Health Canada through the FDA’s joint eStar program. Huma’s tech also includes remote patient monitoring (RPM) systems and companion apps to enable disease management, with third-party device integration. For providers, the platform hosts AI algorithms that use automated data analytics to support screening, diagnosis, dosing recommendations, clinical decision making, and prognostication for identification of at-risk patients and early intervention. In 2020, Huma acquired BioBeats and TLT; more recently, last year iPLATO patient engagement and in January clinical trials data specialist Alcedis.   Huma release, Mobihealthnews

The growth of behavioral health has come to a screeching halt with the demonstrated abuse of online prescribing, then the US Drug Enforcement Administration (DEA)’s uncertainty around controlled substance prescribing. This interview with the CEO of Array Behavioral Care, one of the Ur-companies in telepsychiatry (1999, originally InSight Telepsychiatry and Regroup Telehealth), points out how the DEA’s post-Public Health Emergency (PHE) policies around Schedule II and higher teleprescribing disrupted their operations. The flexibilities established during the PHE have been waivered to 11 November, though a final rule must replace the temporary extension rule and comply with the Federal Ryan-Haight Act [TTA 11 May]. Other issues addressed are dealing with medical affairs (clinical licensure, primary source credentialing, facility privileging, and payer enrollment), and the potential for AI to create new tools to aid clinicians in evaluating mental health, such as natural language processing (NLP) in transcribing video sessions and suggesting clinical notes, as well as scanning patient intake stories and analyzing that information for the likelihood of certain diagnoses. HealthcareITNews

The slow drip-drip-drip of layoffs, folded companies’ asset sales, and company losses that started in 2022 continue, though at a diminished pace compared to consumer companies:

  • Genomics and DNA testing company 23andMe announced layoffs of 9% of staff or 75 people. This will take place by the end of their FY 2024, which ends next 31 March. In a 9 June filing, the company claimed that it would reduce annualized payroll and benefit expenses by $12.8 million, which leads one to wonder about the compensation level of those 75 and from what area they are in. South San Francisco-based 23andMe continues to be money-losing, increasing annual net losses from $217 million to $317 million in the 12 months ending in March, according to its May earnings report despite a 10% revenue gain. 23andMe is yet another ‘cracked SPAC’, having gone that route in 2021 with a Virgin-backed SPAC. Once trading at highs of $12-13 on the NYSE, it closed today at $1.96. However, they don’t have debt, are hanging on to a valuation of $924 million, and their cash position is apparently strong enough to hold it for two years.  Becker’s, SF Chronicle, Yahoo Finance, SimplyWallStreet
  • Another well-financed company, Cityblock Health, is laying off 12%, or 155 staff. Spun off from Sidewalk Labs (Alphabet Health-Google) at the end of 2017, their CEO announced the layoffs in a blog post late last week and effective immediately for those affected. Cityblock serves Medicaid and low-income ‘duals’ with both Medicare and Medicare in value-based care models with a heavy reliance on technology. Their CEO who joined the company in March phrased it as a restructuring, using technology to automate processes, and reducing staff layer. In contrast to others, Cityblock has had no trouble raising funding in the past; in December 2020 they raised $160 million in a December 2020 Series C, plus another $192 million in a Series C extension in March 2021, then a reported $400 million Series D in September 2021 with total raises over $890 million. But their cash burn with high-cost operations in six states (HQ New York, Massachusetts, Indiana, North Carolina, Ohio, and Washington DC) is also likely high. FierceHealthcare
  • Thirty Madison buys assets from bankrupt The Pill Club. The assets? Over 100,000 patient files for $32.3 million. The Pill Club entered Chapter 11 in April after being charged by California authorities of defrauding the state Medicaid program. It paid $18.3 million to settle the charges. But that wasn’t all. According to Mobihealthnews, “the settlement came just days after a state court unsealed a whistleblower complaint against the company in which former nurse practitioners alleged it had defrauded private insurers in at least 38 states. According to a statement from their attorneys regarding the settlement, the whistleblowers would receive approximately $5 million.” The patients covered by The Pill Club’s prescriptions will be converted over to another Thirty Madison brand, Nurx, and offered other services such as behavioral health and dermatology services. The Pill Club raised a lot of money from 2016–$51 million in Series B funding in 2019 and another $41.9 million in 2021. Thirty Madison is a private multi-line of consumer-marketed brands such as Keeps (hair), Picnic (allergies), Cove (migraine), and Facet (psoriasis, eczema) and is at a Series C with a total raise of $209 million. Axios, 
  • Butterfly Network, which some years back developed a hand-held ultrasound device (Butterfly iQ) and entered a crowded field with GE HealthCare’s VScan, Mobisante (apparently defunct), and Philips Lumify, reported Q1 revenue of $15.5 million, flat year-over-year compared to Q1 2022 and which missed analyst estimates (again). Somewhat better news was narrowing last year’s loss to a Q1 loss of $33.5 million which was less than Q1 2022’s loss of $44.5 million. It’s another early SPAC that hasn’t had a great time of it. Since its debut on the NYSE in December 2021, the stock has had the typical drop in altitude from $19.79 to $2.42. It has since expanded to enterprise imaging with Blueprint. Mobihealthnews, Yahoo Finance, Zachs

Global deals roundup: bubbly Butterfly blank check, Imprivata-FairWarning, Virta Health, OTV, WithMe Health, Perfood, Sofía

Christmas is definitely bubbly in the global tub, in the year-end rush to finalize those Big Deals and Corral That Cash.

‘Blank check’ acquisitions accelerate. The latest digital health SPAC (special purpose acquisition company) is hand-held ultrasound developer Butterfly Network with Longview Acquisition Corp. Longview, a SPAC sponsored by Glenview Capital Management, LLC, brings the listing on the NYSE, Butterfly brings the name and the tech. The deal is valued at $1.5 billion and is expected to have an estimated $584 million in cash after closing expected in Q1 next year. The combined company will trade under BFLY. Existing investors remain and will convert to common stock shareholders. Founder Dr. Jonathan Rothberg will be chairman and largest controlling shareholder. The company’s product is the Butterfly iQ+ hand-held ultrasound probe and mobile software. priced at $1,999 plus a ‘membership cost’ of a standard $99/year. Release This follows on last week’s three-way SPAC with GigCapital2 Inc., UpHealth Holdings, and Cloudbreak Health LLC [TTA 26 Nov].

Data security is hot too. Imprivata, which specializes in digital identity management for healthcare organizations to secure workflows and IT systems, just picked up the FairWarning Technologies insider threat prevention, patient privacy, and data security platform. FairWarning has worked with leading US health systems such as Mount Sinai Health System (NYC), Memorial Hermann (Houston), plus in the UK NHS Lothian and NHS Homerton. Not surprisingly as both companies are in the business of privacy, terms of the deal, timing, and leadership team were not disclosed. Healthcare IT News, Imprivata release.

Virta Health gained a healthy Series D with a $65 million raise, led by Sequoia Capital Global Equities. Virta now has a total funding of $231 million and now has joined the unicorns with a valuation of $1.1 bn. Virta’s treatment using remote patient coaching and carbohydrate dietary restriction reverses Type 2 diabetes, reducing A1C and eliminating the patient’s requirement for diabetes medications. Bloomberg, Virta release

Israel’s Olive Tree Ventures has rebranded itself as OTV and announced the closing of a $170 million fund with a total value of $170M. It is Israel’s first and only primarily digital health venture capital fund. Joining the company is a new Head of Asia Pacific, Jose Antonio Urrutia Rivas, for planned expansion into that market. Release

WithMe Health, an app-based personalized medication guidance company, raised $20 million in a Series B funding led by OMERS Ventures with existing investor Oak HC/FT and new investors Section 32, Shulman Ventures, and MTS Ventures. Release

In Germany, digital therapeutics startup Perfood GmbH raised a €5 million ($5.9 million) Series A to launch its first prescription therapeutics next year. Boehringer Ingelheim Venture Fund led the round, with UV-Cap and investiere. Their personalized nutrition products based on DNA sequencing and gut microbiomes are prescribed as alternatives or add-ons to conventional medications. Their first product available for prescription (in Germany only) will be sinCephalea for treating episodic migraine. MillionFriends is their weight management program based on coaching, gut microbiome analysis, and nutrition management. Mobihealthnews

And in Latin America, Sofía, a Mexico City-based telemedicine and insurance startup, gained a $19 million Series A funding, led by Index Ventures with Calvary Ventures, Kaszek Ventures, and Ribbit Capital. Started by three friends at the Instituto Tecnológico Autónomo de México (ITAM), the company launched with a COVID-19 related telemedicine service, grew quickly to 10,000 users, then moved into insurance, using a core group of 100 physicians in the D.F. in 70 different specialist areas. TechCrunch

Butterfly IQ handheld ultrasound offers clinical-quality body imaging for under $2,000

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2018/03/butterfly-iq.jpg” thumb_width=”200″ /]Butterfly IQ is a NYC and Connecticut-based company which has developed a handheld ultrasound that transmits images to a smartphone. Where it differs from current handhelds like GE’s VScan is that it uses a single transducer for all images both near-field and deeper in body, and connects to a iPhone loaded with their software.

Larger machines, even on portable carts like the Philips Lumify [TTA 27 Mar] operate on an older vibrating crystals-based technology. The IQ uses capacitive micro-machined ultrasound transducers or CMUTs. 

It claims to be FDA-cleared for 13 applications. All this is delivered for under $2,000, far under other handhelds or carts (VScan is above $12,000, Lumify about $6,000), with delivery this year (pre-order notification at present) in the US only. Butterfly is also working on problems such as the volume of blood a heart is pumping or detecting problems like aortic aneurysms.

The IQ has a brace of impressive testimonials from doctors at Yale, UC Irvine, Denver Health, Rocky Vista University, Mass General, St. Elizabeth’s (Boston), and Metrowest Medical Center. According to vascular surgeon and company chief medical officer Dr. John Martin, he used it on himself to diagnose a mass in his neck last year that turned out to be Stage 4 cancer, for which he is under treatment. Daily Mail, 9to5 Mac, MIT Technology Review  Hat tip to Editor Emeritus Steve Hards