This article was originally published in The Gray Sheet
Acquires EyeTech Vision A.G.' s Krumeich-Barraquer microkeratome, an instrument used to create the corneal flap in laser in situ keratomileusis procedures, Summit says Oct. 29. The company will assume international sales responsibilities immediately; release in the U.S. is expected following FDA clearance of a pending 510(k). Twenty-five of the devices, which sell for between $55,000-$60,000 each, have been sold in fourteen countries outside the U.S., Summit notes. The system is the only microkeratome device "that has critical surgical parameters controlled by a computer system," Summit claims
You may also be interested in...
3D-printing company Carbon and in vitro diagnostics maker Resolution Medical announced plans to manufacture more than one million 3D-printed nasal swabs per week to test for COVID-19. See what Resolution Medical’s president Shawn Patterson said about it here.
FDA warning to "Genesis II Church of Health and Healing " wasn't its first to the organization about promoting a chlorine dioxide formulation, "Miracle Mineral Solution," as an unapproved new drug. 'Infowars' host Alex Jones also was warned about bogus COVID-19 claims.
The first major revision since 2007 notably provides a legal foundation for special approvals under a public health crisis.