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A tumultuous year at the Food and Drug Administration will be capped off at the agency’s devices center with the departure of two key leaders, just as regulators are sorting through challenges related to artificial intelligence and launching new initiatives on software as a medical device regulation. 

• Sources tell us Jessica Paulsen, a 15-year veteran of FDA and acting deputy director of its Digital Health Center of Excellence is leaving the agency. She’s been leading the center since last summer when the last acting head, SonjaFulmer, left FDA for Mayo Clinic. Fulmer took over for Troy Tazbaz who left in January to return to Oracle. The center’s work includes communicating with industry and developing guidances relevant to digital health. (FDA did not respond to a request for comment.)
• Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s office of neurological and physical medicine devices, which is in charge of regulating Neuralink. McMullen spent three years atop the office and previously worked at the National Institute for Mental Health.

• Both Paulsen and McMullen were at the forefront of important conversations about the future of regulation. I grabbed the screenshot above of the two leaders from a video of last month’s Digital Health Advisory Committee meeting on generative AI-enabled mental health devices. Separately, McMullen’s office will have oversight of behavioral health devices under the FDA’s new TEMPO pilot.
• New to me: As part of the funding package that reopened the government last month, lawmakers passed full-year 2026 funding for FDA. Buried within the Senate report accompanying the legislation, lawmakers direct FDA to, within 90 days, (February) report on its authorities to regulate AI medical devices, and within 180 days, (May) report on “the status of the  FDA’s efforts regarding engagement on AI in drug development.” 
• The Government Accountability Office last week released a report on medical device recalls which found, among other things, that “insufficient staff limit FDA’s ability to conduct oversight activities.” In other words, the FDA already does not have enough staff to oversee medical devices and is losing key leadership at a time when new technology and initiatives may require additional horsepower.

The future of the mammogram

Applying AI to mammograms to help radiologists spot signs of breast cancer is increasingly common but researchers and AI companies want to apply new analyses to the routine screening tests to trigger more proactive care to prevent future cancers, heart attacks, and strokes. In one important breakthrough, the startup Clairity received FDA authorization for AI that offer a prediction of somone’s five-year breast cancer risk based on a mammogram alone.

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This essay is part of a First Opinion series on the future of the National Institutes of Health and American science.

Around the world, nations with robust research and development infrastructure race to create therapeutics that meet the needs of their residents. Simply put, they dictate research priorities based on need. During the Covid pandemic, the United States was one of the first countries to gain access to vaccines to protect its citizens.

Read the rest…

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In an exceptional year for biotech and pharma, there were so many outstanding CEOs, I couldn’t single out just one for my 2025 Best Biopharma CEO honor.

Here are this year’s winners: 

The dealmakers 

2025 has been the best year for biotechs being acquired by pharma companies since 2019, with nearly $240 billion worth of deals announced or closed through November, according to Stifel.

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© Hyacinth Empinado/STAT

Background: To date, there is no comprehensive paper that systematically synthesizes the effect of generative AI chatbot’s impact on mental health. Can generative AI chatbots help reduce our psychological distress? Objective: To comprehensively assess existing evidence, a systematic review and meta-analysis is essential to evaluate the overall effectiveness, identify gaps, and guide future research in this evolving field. This paper aims to: 1) synthesize current evidence on generative AI chatbot interventions targeting mental health issues, 2) quantify the effectiveness of these interventions via a meta-analysis of randomized controlled trials (RCTs), and examine key moderators of intervention effectiveness. Methods: This systematic review included 26 studies for narrative synthesis, out of which 12 randomized controlled trials were included in the meta-analysis. Results: The systematic synthesis revealed that 1) generative AI-chatbot interventions mostly took place in non-WEIRD countries (Western, Educated, Industrialized, Rich, and Democratic) and 2) there is a lack of studies focusing on young children and older adults. The meta-analysis showed a statistically significant effect (ES = 0.36, p = .039), which means that generative AI chatbots are, on average, effective in reducing negative mental health issues. Among moderators, we found statistically significant and higher effect sizes among interventions that have an active control group, conducted in WEIRD countries, recruited non-clinical populations, older age, majority female, non-personalized, with human assistance, and social-oriented. Conclusions: In conclusion, this comprehensive review has highlighted the potential of generative AI chatbots in addressing anxiety, depression, negative mood, and stress. The findings indicate that generative AI interventions are particularly beneficial in WEIRD countries, among non-clinical populations, older adults, and females. Human-assisted and social-oriented programs, as opposed to fully autonomous or task-oriented ones, demonstrate greater effectiveness. Meanwhile, non-personalized chatbots appear to yield more effective outcomes than personalized systems.

This is today’s edition of The Download, our weekday newsletter that provides a daily dose of what’s going on in the world of technology.

The great AI hype correction of 2025

Some disillusionment was inevitable. When OpenAI released a free web app called ChatGPT in late 2022, it changed the course of an entire industry—and several world economies. Millions of people started talking to their computers, and their computers started talking back. We were enchanted, and we expected more.

Well, 2025 has been a year of reckoning. For a start, the heads of the top AI companies made promises they couldn’t keep. At the same time, updates to the core technology are no longer the step changes they once were.

To be clear, the last few years have been filled with genuine “Wow” moments. But this remarkable technology is only a few years old, and in many ways it is still experimental. Its successes come with big caveats. Read the full story to learn more about why we may need to readjust our expectations.

—Will Douglas Heaven

This story is part of our new Hype Correction package, a collection of stories designed to help you reset your expectations about what AI makes possible—and what it doesn’t. Check out the rest of the package here, and you can read more about why it’s time to reset our expectations for AI in the latest edition of the Algorithm, our weekly AI newsletter. Sign up here to make sure you receive future editions straight to your inbox.

Quantum navigation could solve the military’s GPS jamming problem

Since the 2022 invasion of Ukraine, thousands of flights have been affected by a far-reaching Russian campaign of using radio transmissions that jammed its GPS system.

The growing inconvenience to air traffic and risk of a real disaster have highlighted the vulnerability of GPS and focused attention on more secure ways for planes to navigate the gauntlet of jamming and spoofing, the term for tricking a GPS receiver into thinking it’s somewhere else.

One approach that’s emerging from labs is quantum navigation: exploiting the quantum nature of light and atoms to build ultra-sensitive sensors that can allow vehicles to navigate independently, without depending on satellites. Read the full story.

—Amos Zeeberg

The must-reads

I’ve combed the internet to find you today’s most fun/important/scary/fascinating stories about technology.

1 The Trump administration has launched its US Tech Force program
In a bid to lure engineers away from Big Tech roles and straight into modernizing the government. (The Verge)
+ So, essentially replacing the IT workers that DOGE got rid of, then. (The Register)

2 Lawmakers are investigating how AI data centers affect electricity costs
They want to get to the bottom of whether it’s being passed onto consumers. (NYT $)
+ Calculating AI’s water usage is far from straightforward, too. (Wired $)
+ AI is changing the grid. Could it help more than it harms? (MIT Technology Review)

3 Ford isn’t making a large all-electric truck after all
After the US government’s support for EVs plummeted. (Wired $)
+ Instead, the F-150 Lightning pickup will be reborn as a plug-in hybrid. (The Information $)
+ Why Americans may be finally ready to embrace smaller cars. (Fast Company $)
+ The US could really use an affordable electric truck. (MIT Technology Review)

4 PayPal wants to become a bank in the US
The Trump administration is very friendly to non-traditional financial companies, after all. (FT $)
+ It’s been a good year for the crypto industry when it comes to banking. (Economist $)

5 A tech trade deal between the US and UK has been put on ice
America isn’t happy with the lack of progress Britain has made, apparently. (NYT $)
+ It’s a major setback in relations between the pair. (The Guardian)

6 Why does no one want to make the cure for dengue?
A new antiviral pill appears to prevent infection—but its development has been abandoned. (Vox)

7 The majority of the world’s glaciers are forecast to disappear by 2100
At a rate of around 3,000 per year. (New Scientist $)
+ Inside a new quest to save the “doomsday glacier”. (MIT Technology Review)

8 Hollywood is split over AI
While some filmmakers love it, actors are horrified by its inexorable rise. (Bloomberg $)

9 Corporate America is obsessed with hiring storytellers
It’s essentially a rehashed media relations manager role overhauled for the AI age. (WSJ $)

10 The concept of hacking existed before the internet
Just ask this bunch of teenage geeks. (IEEE Spectrum)

Quote of the day

“So the federal government deleted 18F, which was doing great work modernizing the government, and then replaced it with a clone? What is the point of all this?”

—Eugene Vinitsky, an assistant professor at New York University, takes aim at the US government’s decision to launch a new team to overhaul its approach to technology in a post on Bluesky.

One more thing

How DeepSeek became a fortune teller for China’s youth

As DeepSeek has emerged as a homegrown challenger to OpenAI, young people across the country have started using AI to revive fortune-telling practices that have deep roots in Chinese culture.

Across Chinese social media, users are sharing AI-generated readings, experimenting with fortune-telling prompt engineering, and revisiting ancient spiritual texts—all with the help of DeepSeek.

The surge in AI fortune-telling comes during a time of pervasive anxiety and pessimism in Chinese society. And as spiritual practices remain hidden underground thanks to the country’s regime, computers and phone screens are helping younger people to gain a sense of control over their lives. Read the full story.

—Caiwen Chen

We can still have nice things

A place for comfort, fun and distraction to brighten up your day. (Got any ideas? Drop me a line or skeet ’em at me.)

+ Chess has been online as far back as the 1800s (no, really!)
+ Jane Austen was born 250 years ago today. How well do you know her writing? ($)
+ Rob Reiner, your work will live on forever.
+ I enjoyed this comprehensive guide to absolutely everything you could ever want to know about New England’s extensive seafood offerings.

Can I ask you a question: How do you feel about AI right now? Are you still excited? When you hear that OpenAI or Google just dropped a new model, do you still get that buzz? Or has the shine come off it, maybe just a teeny bit? Come on, you can be honest with me.

Truly, I feel kind of stupid even asking the question, like a spoiled brat who has too many toys at Christmas. AI is mind-blowing. It’s one of the most important technologies to have emerged in decades (despite all its many many drawbacks and flaws and, well, issues).

At the same time I can’t help feeling a little bit: Is that it?

If you feel the same way, there’s good reason for it: The hype we have been sold for the past few years has been overwhelming. We were told that AI would solve climate change. That it would reach human-level intelligence. That it would mean we no longer had to work!

Instead we got AI slop, chatbot psychosis, and tools that urgently prompt you to write better email newsletters. Maybe we got what we deserved. Or maybe we need to reevaluate what AI is for.

That’s the reality at the heart of a new series of stories, published today, called Hype Correction. We accept that AI is still the hottest ticket in town, but it’s time to re-set our expectations.

As my colleague Will Douglas Heaven puts it in the package’s intro essay, “You can’t help but wonder: When the wow factor is gone, what’s left? How will we view this technology a year or five from now? Will we think it was worth the colossal costs, both financial and environmental?” 

Elsewhere in the package, James O’Donnell looks at Sam Altman, the ultimate AI hype man, through the medium of his own words. And Alex Heath explains the AI bubble, laying out for us what it all means and what we should look out for.

Michelle Kim analyzes one of the biggest claims in the AI hype cycle: that AI would completely eliminate the need for certain classes of jobs. If ChatGPT can pass the bar, surely that means it will replace lawyers? Well, not yet, and maybe not ever. 

Similarly, Edd Gent tackles the big question around AI coding. Is it as good as it sounds? Turns out the jury is still out. And elsewhere David Rotman looks at the real-world work that needs to be done before AI materials discovery has its breakthrough ChatGPT moment.

Meanwhile, Garrison Lovely spends time with some of the biggest names in the AI safety world and asks: Are the doomers still okay? I mean, now that people are feeling a bit less scared about their impending demise at the hands of superintelligent AI? And Margaret Mitchell reminds us that hype around generative AI can blind us to the AI breakthroughs we should really celebrate.

Let’s remember: AI was here before ChatGPT and it will be here after. This hype cycle has been wild, and we don’t know what its lasting impact will be. But AI isn’t going anywhere. We shouldn’t be so surprised that those dreams we were sold haven’t come true—yet.

The more likely story is that the real winners, the killer apps, are still to come. And a lot of money is being bet on that prospect. So yes: The hype could never sustain itself over the short term. Where we’re at now is maybe the start of a post-hype phase. In an ideal world, this hype correction will reset expectations. 

Let’s all catch our breath, shall we?

This story first appeared in The Algorithm, our weekly free newsletter all about AI. Sign up to read past editions here.