October 2, 2023

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Omada Well being introduced it would launch a new service to assist employers reply to the hovering demand for expensive GLP-1 weight loss treatments like Wegovy. When staff of collaborating firms search to have their remedies coated by well being plans, they’ll be requested to affix Omada’s program that encourages way of life adjustments that may assist individuals maintain weight off.

Omada, which provides a bunch of digital persistent illness administration applications that concentrate on conduct change, gained’t really write or fill prescriptions for the medicine, a service that CEO Sean Duffy informed STAT has been commoditized to the purpose that individuals don’t want extra choices.

The place Duffy thinks Omada will help is enhancing longer-term outcomes for individuals who select to take GLP-1s. Although it’s unclear what long-term protection for novel weight reduction medicine would possibly appear like, Duffy mentioned the corporate’s shoppers are leaning in direction of overlaying the medicine for a 12 months or two. Many individuals who use Wegovy regain weight as soon as they arrive off the drugs.

“In case you’re not benefiting from the optimistic inertia {that a} drugs like this will construct with somebody by inspiring a distinct mind-set about habits, possibly a distinct relationship with meals, you’re much less prone to get sustainability,” he mentioned.

Duffy acknowledged that whereas it’s believable that conduct change applications like Omada’s coupled with medicine might yield longer-lasting advantages — or no less than “stem the slope of the regain” — it’s a speculation with out proof for the time being. He mentioned the corporate is dedicated to producing proof that helps the claims in the long term.

In the end, Duffy mentioned the corporate’s method is sensible as a result of it could possibly encourage the change that’s written proper on product label: “Wegovy ought to be used with a decreased calorie meal plan and elevated bodily exercise.”

In associated information: Shopper weight reduction firm  Noom this week launched Noom Med, which provides GLP-1s to “medically qualified individuals.”

Microsoft well being chief talks Nuance adoption, preaches gospel of low-risk AI

Throughout his keynote at The New Wave of AI in Healthcare convention in New York this week, Microsoft’s international chief medical officer & vp of healthcare David Rhew laid out his imaginative and prescient for the alternatives for AI to enhance care, which maybe unsurprisingly included a very good chunk of selling for ambient scientific intelligence enabled by Nuance, which Microsoft acquired final 12 months for $16 billion.

Pressed on the corporate’s progress on adoption, he mentioned that the most important driver has been hospitals attempting to handle clinician burnout. With rising pleasure round AI, Rhew urged that potential prospects will likely be extra open to piloting Nuance to see the way it would possibly work with their methods. In March, the corporate announced DAX Express, a model of its dictation tech that makes use of OpenAI’s GPT-4 to allow entry to scientific notes sooner after exams. Since then, he mentioned, “demand has been via the roof.”

Earlier in his presentation, Rhew urged the leaders within the room to method use circumstances for rising applied sciences enabled by cutting edge technologies like GPT-4 with warning.

“Somewhat than begin with the toughest one, let’s begin with those which have a big effect however have the bottom threat,” he mentioned.  “… It’s virtually like if we simply received a pair of skis and we see that, wow, we are able to go down these hills, let’s not go on the double black diamond. Let’s attempt to grasp the bunny hill first.”

Overheard: Information challenges of AI

Following Rhew’s keynote on the convention, which was hosted by Mount Sinai’s Icahn College of Medication (ISMMS) and The New York Academy of Sciences, specialists wrestled with a few of the greatest challenges of growing and deploying AI. A number of selection bits I overheard:

    • In case you suppose that you just’re operationalizing race to get at some kind of social or socio-structural one thing, then I might say put the socio-structural one thing in your mannequin. Don’t suppose that you just’re going to seize that. ” That’s what Emma Benn, director of the middle for scientific variety at ISMMS, informed an viewers member who requested whether or not researchers ought to embody or exclude race and ethnicity as variables in AI fashions in the event that they appear to have predictive worth. Some specialists counsel together with that information in fashions can perpetuate disparities. Benn mentioned there stays debate about how greatest to deal with the difficulty.“When one assumes that, properly, it’s racist that race is within the algorithm, so I’m going to take away race from the algorithm. I might say that it’s not that simplistic and the algorithm might nonetheless be racist,” she mentioned.
    • “I believe typically it’s tough to conceptualize pathology information for those who haven’t handled pathology information,” ISMMS computational scientist Gabriele Campanella informed an viewers member who requested in regards to the scalability of designing AI fashions based mostly on pathology slides that common 1.7 gigabytes and tons of of 1000’s of pixels every. Mount Sinai has its personal devoted excessive efficiency computing cluster crunching one of many largest repositories of slides on the planet —  sources accessible to solely a handful of establishments. However Campanella mentioned at some point it might be able to launch basis fashions that others can fine-tune for their very own functions.

FDA prepares guidelines for drug-related apps

The Meals and Drug Administration is predicted to launch new steerage on apps designed to work with prescribed drugs this 12 months.

Drug firms have already got merchandise which might be supposed for promotional functions, to assist adherence, assist sufferers handle their circumstances, or present dosing steerage. Martin Culjat, SVP and international head of digital drugs & regulatory innovation at consultancy Eversana informed STAT that the forthcoming steerage, which might come as quickly as this summer time, will present readability to firms growing apps which have an “additive scientific impact.” That’s the place the principles “get just a little bit extra fuzzy.”

Eversana helps risk-averse drug firms with larger concepts navigate the murky waters.

“The intention is usually to have some sort of influence on affected person outcomes,” mentioned Culjat. For firms who need to do extra with apps, “there’s plenty of uncertainty. Are you able to reference the app on the drug labeling? What sort of scientific trials do you need to run? Do you need to submit one thing as a part of a brand new drug software?” 

Proper now, it seems FDA anticipates most drug-related apps gained’t want regulatory approval.

In these circumstances, “solely the output of those apps will should be reviewed as promotional drug labeling,” Culjat wrote in an article on the topic. The brand new framework, nonetheless, “doesn’t alter and is unbiased from the regulatory framework for medical gadget software program.”

FDA began fascinated about this lengthy earlier than the present explosion of curiosity in digital well being: In 2018, it posted a few of its considering on the subject, and obtained feedback from representatives from firms like Omada, and drugmakers NovartisOtsukaTakeda, and Teva.

Boston Scientific acquisition nixed

Boston Scientific is scrapping its $230 million plan to purchase a majority stake in M.I. Tech, a Korean firm that builds surgical instruments. As a substitute, the corporate will purchase round 10%.

“Our settlement to buy the bulk stake of M.I.Tech Co., Ltd, from Synergy Innovation Co., Ltd, required international regulatory approvals that we weren’t in a position to receive in some nations,” Boston Scientific spokesperson Kate Haranis told STAT’s Lizzy Lawrence.

The Federal Commerce Fee said the deal fell apart aside in response to “investigations by FTC workers and our abroad enforcement companions.”The medical gadget large had agreed to buy round 64% of the corporate final June. Boston Scientific focuses on minimally-invasive medical units, and M.I. Tech would have contributed to its portfolio of non-vascular stents, units that clear blockages within the physique.

Read more here.