‘Major Milestone:’ FDA Gives CLIA Waiver To Chlamydia, Gonorrhea Test
The 30-minute Binx IO test will now be available to more than 220,000 point-of-care facilities that have a CLIA waiver. Health experts say it will help treat patients faster and stymie the spread of STIs.
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US FDA Revisits Gonorrhea Drug Development As Fast-Emerging Resistance, Preclinical Challenges Hold Back New Products
From animal models to non-inferiority margins, US FDA is seeking new perspectives on gonorrhea R&D, including how to incorporate extragenital infections into clinical programs.
The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.
Digital Health Roundup: Exec Chats With Illumina, Bloom, AngelMed; M&A, Funding; FDA Down-Classifies Apps
In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights IBM Watson Health’s divestiture and other financing news, Exec Chats with Illumina, AngelMed and Bloom, Philips’ new hand-held ultrasound device and autonomous robotic surgery, as well as the latest FDA news on digital health.