FDA speaks on at-home flu/Covid test approval

Lucira, the maker of the first authorized home Covid-19 and flu combination test, declared bankruptcy last week — just days before the Food and Drug Administration authorized the test for emergency use. Lucira blamed the FDA's "protracted" approval process for their money problems. Now, the FDA has released a rare comment that offers a behind-the-scenes glimpse into the agency's timing and rationale.

Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said the agency ultimately authorized Lucira's test with fewer samples than the agency had previously said it would require. The FDA's decision was bolstered by data the National Institutes of Health provided on the tests. Shuren said the statement was "part of the FDA's commitment to address misinformation." Read more from my colleague Brittany Trang here.

misinformation

Can the FDA actually tackle online misinformation?

Speaking of addressing misinformation…can the FDA handle the explosion of health-related falsehoods that worsened the Covid-19 pandemic? STAT contributor Ben Brody spoke with FDA Commissioner Robert Califf about whether the agency needs to revamp its guidance on how FDA-regulated manufacturers should deal with online misinformation.

Researchers at Harvard and Yale argued in a Nature paper in January that the agency needs to take a more aggressive approach to misinformation by regulating online health information and redesigning drug labels. But Califf and other health exports told STAT that efforts to control health misinformation by taking aim at platforms may be on legally shaky ground — and could well risk backlash at a moment when health care and free speech are both highly politicized. Read more here.

medical devices

Breakthrough devices in 2023

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While my colleagues Katie Palmer and Mario Aguilar are away, I've been keeping tabs on the devices earning breakthrough designations from the FDA. A STAT investigation last year revealed that the FDA's breakthrough devices program — meant to benefit patients by speeding up the development and review of cutting-edge medical devices — delivers the most gains to companies.

Breakthrough devices, as defined by the FDA, are supposed to one day prove to be "more effective" at treating or diagnosing deadly and debilitating conditions. You can explore hundreds of breakthrough designations in STAT's regularly updated tracker here. Here are three out of the at least 10 devices that have been deemed "breakthroughs" so far this year:

Finnish device maker Sooma Medical announced breakthrough status on Monday for its neuromodulation device to treat depression. The device uses a mild electrical current to stimulate certain brain areas, which are meant to improve depressive symptoms.
Two liquid biopsy cancer detection devices, one from Chinese biotech company Burning Rock and another from San Diego-based company Micronoma, announced breakthrough designations in January. Micronoma is focused on early detection of lung cancer, whereas Burning Rock's is meant for multiple cancer types.
Startup Opticyte announced breakthrough status in January for its continuous monitoring device for patients at risk of organ failure. The device monitors oxygen levels inside cells while patients are hospitalized with conditions like sepsis or trauma.

telehealth

Cerebral admits to disclosing sensitive user data

Mental health startup Cerebral has informed its users it may have violated HIPAA by sharing sensitive health data, in violation of HIPAA. Cerebral is just one of dozens of telehealth companies that STAT and The Markup found in December had shared data with Big Tech. In notifications sent Tuesday morning, Cerebral told customers that the breach could have included information about treatment, health insurance, and user responses to intake surveys. Cerebral clarified that the data may be classified as protected health information under HIPAA.

device safety

FDA warns about breast implants and skin cancer

There have been at least 19 cases of skin cancer that have developed in the scar tissue that forms around breast implants, according to a literature review conducted by the FDA. The agency released a statement on Wednesday updating the public on the breast implant complication, which it first discussed in September 2022. Such cases may be rare, but the cause, frequency and risk factors remain unknown. The FDA called for patients and providers to report any cases to regulators, and urged providers to inform patients and those considering implants about skin cancer in scar tissue.

health tech

Industry news

Online health care company Accolade will reduce its workforce and office footprint, according to a filing with the Securities and Exchange Commission.
Mental health company Spring Health has tapped Mill Brown as its chief medical officer. Brown was previously a senior vice president for medical affairs.
The European Council voted unanimously to give device makers more time to certify their devices under the Medical Devices Regulation rules, to the approval of device lobby group AdvaMed and MedTech Europe, its European counterpart.

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What we're reading

Sam Altman invested $180 million into a company trying to delay death, MIT Technology Review
With CRISPR cures on horizon, sickle cell patients ask hard questions about who can access them, STAT
How major retailers are trying to change how America consumes health care, Axios