CooperVision Nabs Approval On Pediatric Contact Lens
MiSight is first lens to prevent progression of myopia in children
A newly approved contact lens from CooperVision promises to slow the progression of nearsightedness when prescribed to children aged 8 to 12.
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Global Approvals Snapshot: November 2019
November’s approvals include the US FDA approval of Medtronic’s In.Pact AV paclitaxel-coated balloon, for the treatment of arteriovenous access in patients with end-stage renal disease, and a CE mark that expands the indication for Edwards’ Sapien 3 TAVR device to include patients at low-risk during surgery.
COVID-19 EUAs To Stay Active After Public Health Emergency Ends
Authorizations in place for diagnostics, personal protective equipment, and other products cleared for emergency use during the pandemic will remain in place until the potential for an outbreak no longer exists or products receive traditional clearances, according to a Federal Register notice issued by HHS this week.
News We’re Watching – FDA Mammography Update, SVB Collapse, Zoll's Data Breach, And More
News we are keeping an eye on this week includes the FDA’s first traditional market authorization for a COVID-19 test and its approval of a new neurological diagnostic. The agency also updated its device shortage list and revised mammography guidelines.