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Mental health tech companies are bracing for the FDA to tighten the reins

In April 2020, the Food and Drug Administration announced an emergency policy giving companies wide berth to release apps to address a mental health crisis that experts feared would only get worse under lockdown. It was a boon to emerging companies developing digital therapeutics for depression, ADHD, substance use, and other conditions. In the years since, they’ve been able to test drive their products in the real world without seeking FDA marketing authorization, which can require years of expensive clinical trials.

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Now, companies who took advantage of the freedom to advance their product pipelines are watching anxiously as FDA prepares to roll back the allowances. Mario has a close look at how companies like LimbixFreespiraBig Health, and others are grappling.

A major boost for telehealth in Title X 

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The Health and Human Services Department doled more than $16 million out in grants to groups focused on expanding virtual care in Title X family planning clinics across the country — an attempt by the Biden administration to preserve reproductive care as the Supreme Court appears ready to overturn Roe v. Wade and as states move to restrict abortions. “Across the nation we are seeing attacks on sexual and reproductive health care services, and through these funds and other HHS efforts we can ensure that we’re able to provide this care that so many across the country need,” HHS secretary Xavier Becerra said. The funds come from American Rescue Plan and support projects for one year starting in mid-May.

Can Google’s Google Pixel Watch take on Apple?

Google on Wednesday teased its long-rumored Pixel Watch at Google I/O, the company’s annual developer conference. SVP of devices and services Rick Osterloh detailed some of the features including activity and fitness tracking features from Fitbit, which Google acquired last year.  Though the company has produced an Android-based wearables operating system, Wear OS, since 2014, this Google’s first foray into developing a smartwatch in-house.

Google’s very late to the smartwatch game and there are many unanswered questions. How will Google make up lost ground to Apple, which has spent seven years building out health functionality of its Watch and creating connections with research organizations? Given how important health functionality has become for wearables marketing, can Google sell a message about health after restructuring its health unit? Or can a smartwatch succeed without a strong health angle? Osterloh said there would be more details about the Pixel Watch — which will launch this fall —in the months ahead.

Hims & Hers earnings beat expectations

Virtual care has seen mixed results on Wall Street as buzzy companies struggle to make telehealth profitable. While Teladoc stumbled last month, Hims & Hers, the direct-to-consumer purveyor of hair loss medication, contraception, and skin care products, exceeded expectations this quarter and even revised its revenue guidance upward for the year. The first quarter of 2022 generated $101.3 million in revenue, almost double the first quarter the previous year.

Growth was driven by the company’s largest ever quarterly gain in subscriptions — as demonstrated in the above slide from Hims & Hers’ investor deck — that tipped subscriptions over 710,000. The company had also recently doubled its skincare offerings, worked with Goodpath on educational programs for sleep and joint issues, and partnered with Carbon to offer in-person primary care.

A better approach to medical AI?

More and more research is focusing on the ways that medical models can introduce algorithmic bias into health care. But in a new paper, machine learning researchers caution that such self-reflection is often ad hoc and incomplete. They argue that to get “an unbiased judgment of AI bias,” there needs to be a more routine and robust way of analyzing how well algorithms perform. Without a standardized process, researchers will only find the bias they think to look for. To make that possible, the researchers provide a new framework designed to help regularly and holistically assess for drops in performance. Read Katie’s new story on the effort here.

Deals and partnerships

  • Blue Note Therapeutics, which is developing prescription digital therapeutics for the treatment of cancer-related anxiety and depression, inked a deal with Bixink Therapeutics, which will commercialize its products in South Korea. Its the latest such licensing deal taking US-developed products to Asia.
  • Turquoise Health, a startup tackling healthcare pricing and contracting, raised a $20 million Series A from Andreessen Horowitz with participation from Bessemer, Box Group, and Tiger Global.

Names in the news

Alphabet subsidiary Isomorphic Labs, which aims to use machine learning for drug discovery, added Miles Congreve as its chief scientific officer, Sergei Yakneen as chief technology officer, Max Jaderberg as director of machine learning, and Alexandra Richenburg as director of people operations. Congreve most recently served as chief scientific officer at Sosei Heptares; Yakneen was chief technology officer at SOPHiA GENETICS; Jaderberg was a research scientist at DeepMind, and Richenburg was senior vice president of people at Eigen Technologies.

What we’re reading

  • Telehealth abortion pill providers targeted by US activists, The Financial Times 
  • Hundreds of patient data breaches are left unpunished, The BMJ 
  • Oscar Health leaves two states amid regulatory, commercial challenges, Modern Healthcare
  • A new biotech investment firm, headed by a pair of noteworthy VCs, seeks to ‘free the founders’, STAT

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