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Mental health tech companies brace for FDA to tighten the reins
In April 2020, the Food and Drug Administration announced an emergency policy giving companies wide leeway to launch apps to tackle a mental health crisis that experts feared would worsen under lockdown. It’s been a boon for emerging companies developing digital therapies for depression, ADHD, substance use and other conditions. In the years that followed, they were able to test their products in the real world without seeking marketing clearance from the FDA, which can take years of expensive clinical trials.
Now, companies that have enjoyed the freedom to advance their product pipelines are watching anxiously as the FDA prepares to roll back the quotas. Mario takes a close look at how companies like limbix, Freespira, great healthand others are struggling.
A major telehealth boost in Title X
the Department of Health and Social Services has given more than $16 million in grants to groups focused on expanding virtual care in Title X family planning clinics across the country — an attempt by the Mr Biden Administration to Preserve Reproductive Care as Supreme Court Seems Ready to Overturn Roe v. Wade and as states work to restrict abortions. “Across the country, we are seeing attacks on sexual and reproductive health care services, and through these funds and other HHS efforts, we can ensure that we are able to provide the care we need. so many people across the country are in need,” the HHS Secretary said. Xavier Becerra said. The funds come from the American Rescue Plan and support projects for one year starting in mid-May.
Can Google’s Google Pixel Watch take on Apple?
Google Wednesday teased its Pixel Watch at Google I/O, the company’s annual developer conference. Senior Vice President of Devices and Services Rick Osterloh detailed some of the features, including the activity and fitness tracking features of Fitbitwhat Google acquired last year. Although the company has produced an Android-based wearable operating system, Wear OS, since 2014, this was Google’s first foray into in-house smartwatch development.
Google is way behind in the smartwatch game and there are a lot of unanswered questions. How will Google make up for lost ground in Apple, who has spent seven years building his watch’s integrity feature and creating connections with research organizations? Given the importance of health functionality to wearable marketing, can Google sell a health message after restructuring its health unit? Or can a smartwatch succeed without a strong health angle? Osterloh said there will be more details on the Pixel Watch – which will launch this fall – in the coming months.
Hims & Hers earnings beat expectations
Virtual care has seen mixed results on Wall Street as hyped companies struggle to make telehealth profitable. While Teladoc tripped last month, Hims & Hers, the direct-to-consumer provider of hair loss medications, birth control and skincare products, beat expectations this quarter and even upgraded its revenue forecast for the year. The first quarter of 2022 generated revenues of $101.3 million, nearly double the first quarter of the prior year.
The growth was driven by the company’s biggest ever quarterly rise in subscriptions – as seen in the Hims & Hers Investor Report slide above – which tipped subscriptions to over 710,000. company had also recently doubled down on its skincare offerings, worked with good path on educational programs for sleep and joint problems, and in partnership with Carbon provide in-person primary care.
A better approach to medical AI?
A growing body of research is focusing on the ways in which medical models can introduce algorithmic biases into healthcare. But in a new paper, machine learning researchers warn that such self-reflection is often unad hoc and incomplete. They argue that to get “an unbiased judgment on AI bias,” there needs to be a more routine and robust way to analyze algorithm performance. Without a standardized process, researchers will only find the bias they think they are looking for. To make this possible, the researchers provide a new framework designed to help regularly and holistically assess performance declines. Read Katie’s new story on the effort here.
Transactions and partnerships
- Blue Note Therapeuticswhich develops digital prescription therapies for the treatment of cancer-related anxiety and depression, has signed an agreement with Bixink Therapeutics, which will market its products in South Korea. It’s the latest such licensing deal that takes US-developed products to Asia.
- Turquoise Healtha startup tackling healthcare pricing and contracting, raised $20 million from Andreessen Horowitz with the participation of Bessemer, Box Groupand TigerGlobal.
Names in the news
Alphabet subsidiary company Isomorphic Laboratorieswhich aims to use machine learning for drug discovery Miles Congreve as Scientific Director, Sergei Yakneen as Chief Technology Officer, Max Jaderberg as Director of Machine Learning, and Alexandra Richenburg as Director of Human Operations. Congreve recently served as Chief Scientific Officer at Congreve Sosei Heptares; Yakneen was Chief Technology Officer at SOPHiA GENETICS; Jaderberg was a research scientist at DeepMindand Richenburg was senior vice president of human resources at Eigen Technologies.
What we read
- Telehealth abortion pill providers targeted by US activists, The Financial Times
- Hundreds of patient data breaches go unpunished, The BMJ
- Oscar Health leaves two states amid regulatory and business challenges, Modern Healthcare
- New biotech investment firm, led by two notable venture capitalists, seeks to ‘unleash the founders’, STAT