In response to the monkeypox outbreak, the Food and Drug Administration has recently authorized two Emergency Use Authorizations for diagnostic kits designed to detect the virus.
News We’re Watching: FDA Issues Monkeypox EUAs, IMDRF Publishes AI Principes, Quest Buys LifeLabs
This week, the US FDA authorized EUAs for at-home mpox tests and announced a public workshop on implanted brain devices; the IMDRF published guiding principles on good machine learning practices for AI; and Quest announced its deal to acquire a Canadian diagnostic firm.
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This week, HistoSonics announced it will bring its ultrasound system for destroying liver tumors into VA hospitals, Edwards Lifesciences reports encouraging TRISCEND II trial results at TCT, study finds blood test for CRC screening are less cost-effective than alternatives, and more.
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This week, Medtronic and Hologic announced major safety issues; the US government awarded $110m to innovators in women’s health; CDC partnered with Quest on a bird flu diagnostic; and more.
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This week, Hologic announced it would pay $350m for uterine fibroid treatment firm Gynesonics; the US FDA authorized a Novocure cancer treatment and a surgical robot from CMR Surgical; and the IMDRF announced 15 new members.
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This week, J&J announced that it was buying heart failure device firm V-Wave; Procept got the FDA’s OK on a clinical trial of its Aquablation treatment for prostate cancer; and CMS began to consider Medicare reimbursement of Abbott’s TriClip tricuspid repair device.
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The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.
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Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.
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Early diagnosis can be “detrimental” to patients, Suzanne O'Sullivan, neurologist and author of “The Age of Diagnosis,” argued at the Wired Health conference on 18 March. "You save one life from screening 2,000 women for breast cancer, but you also treat 10 women unnecessarily," she said.