| | | |  By Casey Ross, Katie Palmer, Mario Aguilar, and Mohana Ravindranath | Mohana and Mario here, running down recent setbacks for blockbuster health tech companies, potential changes to FDA's device review process, and a surprising decline in global wearables shipments. | | | Teladoc slapped with class action lawsuit Just weeks after reporting a $6.6 billion impairment charge for the acquisition of chronic care company Livongo, virtual care giant Teladoc now faces a class action lawsuit alleging that it misled investors about its business performance and prospects. The suit, filed in the U.S. District Court for the Southern District of New York, argues that execs failed to disclose that factors like increased competition — including the threat from new entrants like Amazon and Walmart — were negatively impacting the company’s telehealth, mental health and chronic care business lines. “[A]s a result of all the foregoing, Teladoc would be forced to recognize a significant non-cash goodwill impairment charge,” according to stockholder rights firm Bragar Eagel & Squire. A Teladoc spokesperson said such lawsuits “have become commonplace for public companies,” and that “[t]here is factual basis to the suit whatsoever, but we otherwise can’t comment further on pending litigation.” | Inside Cerebral’s undoing Beleaguered online mental health company Cerebral has seen a series of setbacks recently, culminating in the winding down of its ADHD prescriptions for new patients am a Drug Enforcement Agency probe. But challenges actually surfaced as early as 2020, when the company discovered that patients who paid a monthly fee to see nurse practitioners for online antidepressant prescriptions were canceling their subscriptions after just a few months. At the time, Cerebral found that advertising for ADHD patients instead of depression and anxiety patients yielded more customers, and ramped up its ADHD medication prescription business, according to a new Wall Street Journal report. Now, even that vision is crumbling as the company loses top executives and faces a federal inquiry for potential Controlled Substance Act violations. | The future of FDA device review Congress is currently considering the latest Medical Device User Fee Amendments, or MDUFA V, a crucial accord between the Food and Drug and Administration and industry that will define priorities for the Center for Devices and Radiological Health for the next few years. The proposal is the product of a contentious debate, laid out in a new article in the New England Journal of Medicine by leading health policy experts. During negotiations last year, industry, concerned that review times had been impacted by Covid-19, advocated for spending on hiring and training more FDA review staff to speed up the process. The FDA, meanwhile, was interested in expanded tracking of authorized products and rolling out a new “Total Product Life Cycle Advisory Program,” or TAP, that would take input from patients, physicians, and payers during the premarket process to address commercialization barriers. The resulting compromise offers financial incentives for FDA to meet pre-specified performance goals and penalties if it fails to meet hiring targets. And TAP, which industry worried would slow down premarket review, will start as a limited pilot. The authors argue MDUFA V doesn’t do enough to advance safety and innovation, nor does it give the agency the resources to keep tabs on products on the market. After decades of prioritizing expedited review over understanding the risks and benefits through a product’s entire life cycle, they write, “now is the time to look ahead.” | How a biotech startup is using AI tools to redefine how they approach clinical development Artificial Intelligence is transforming the way small biotechs are scaling their businesses. In our latest case study of Feldan Therapeutics, we show how STAT Trials Pulse has become a game-changer for them, helping accelerate data-gathering, better analyze their competitors, and streamline their operations. Read the case. | Do you know where your resident is? There’s concern among medical educators that interns on rounds are spending too much time in “hallways and conference rooms,” and not enough time with patients. To study what’s going on, researchers from Johns Hopkins strapped 43 interns with infrared badges that recorded their location on rounds for a year. On average. they spent 13% of the tracked time in patient rooms, nearly 24% in ward halls, and 33% in physician workrooms. The authors point out that other research has shown a decline in bedside time since the 1990s, coinciding with a decrease in clinical skill and an increase in burnout. (Though that research doesn't show cause and effect.) So what’s to be done? Take the data from frantic interns and turn it into fixes that make their training better, the authors say. | Wearable shipments face first-ever decline  Global wearables shipments sank for the first time ever in 2022’s first quarter, down about 3% compared to the same quarter in 2021, according to the International Data Corporation’s wearable device tracker. The market research firm said the decline was largely due to “cooling demand” following years of steep growth as consumers gradually buy other types of products. | The latest funding and deals | | | What we’re reading - Tempus’ Eric Lefkofsky argues for health data banks like the ones we have for organ donors, FastCompany
- Providence spins out new analytics software firm combining KenSci, Lumedic, 4 other companies, Fierce Healthcare
- Why healthcare organizations select Amazon Web Services over Google, Microsoft, Becker's Hospital Review
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