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Endpoints News
Thursday, 13 November 2025
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Regulating mental health chatbots
Last week, the FDA held an advisory committee meeting focused on how to regulate “generative artificial intelligence-enabled digital mental health medical devices” (more simply: therapy chatbots).
Here at Endpoints News, we’ve been chronicling the rise of these chatbots, so I tuned in to see the committee grapple with their use for mental health. Some presenters touched on the need to figure out how to navigate strict state bans on therapy chatbots, while others touched on the specifics of how the tools get designed.  
The committee addressed a hypothetical scenario in which a patient with major depressive disorder has turned down therapy recommendations, but is open to using a therapy chatbot. What stuck out to me was that the commentary seemed pretty cautious about these tools. The members pointed out that while they do potentially solve access issues, making chatbots available over-the-counter made them nervous, because of how broad the reach could be. 
(A lot of people are already getting mental health support from chatbots, from both healthcare companies and from tools like ChatGPT for mental health support.) 
AI, as Ngai covers today, has increasingly factored into virtual mental health companies. I’ll be watching to see what kinds of guardrails might come up around therapy chatbots from the FDA, if at all. 
- Lydia
Here’s what’s new
Mental health companies, once wary of AI, are building chatbots
As more peo­ple turn to AI chat­bots for ther­a­py, tra­di­tion­al vir­tu­al men­tal health com­pa­nies that once re­lied sole­ly on hu­mans are build­ing their own ver­sions to adapt.
Lilly drops CVS as drug benefits manager in favor of upstart Rightway — report
Eli Lil­ly has dropped CVS Health as its phar­ma­cy ben­e­fit man­ag­er, se­lect­ing Right­way in­stead, ac­cord­ing to a re­port from Bloomberg News.
Exclusive: Beacon Biosignals raises $86M to build and mine brain data trove
Bea­con Biosig­nals is seek­ing to build an ex­pan­sive brain wave dataset to boost the study of new drugs and di­ag­nos­tics for neu­ro­log­i­cal dis­eases, and it now has $86 mil­lion in fresh fund­ing to help reach its goals.
Quote of the week
“People are using these tools anyway out there in the world. So can we give them a tool that we trust, that we've been part of building?”
Lyra Health Chief Clinical Officer Alethea Varra on chatbots for mental health support
This week in health Тech
Fertility care companies are integrating more data into the services they offer. Carrot on Wednesday said it’s working with Oura and Dexcom to provide wearables for its pre-conception care program. Maven Clinic, meanwhile, revamped its maternity program’s digital experience, bringing in more wearable data like blood pressure monitors, and NICU support.
Amae Health, a startup focused on severe mental illness, raised $25 million. Altos Ventures led the Series B round.
House Rx raised $55 million for its approach to specialty pharmacy using tech and a network of pharmacies and dispensaries within specialty clinics. NEA and Town Hall Ventures led the Series B round. (Editor's note: This feels like the first newsletter in quite a while where we've reported on two Series B rounds).
Mochi Health is offering 15 new health areas like dermatology to sexual wellness. Mochi got its start in virtual weight loss treatment and medication, including compounded versions.
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