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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Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.
The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.
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The urine-based GAGome test showed promise in the first clinical results from the international AURORAX-0087A, in the largest study conducted on clear cell renal cell carcinoma, the most common type of kidney cancer.