Sunrise Sets November Date For Hyperion Amended PMA Submission
This article was originally published in The Gray Sheet
Sunrise Technologies has decided not to pursue a stability indication for its Hyperion laser thermal keratoplasty (LTK) ophthalmic laser system, in an amended premarket approval application to be filed in early November.
You may also be interested in...
Forty-six percent of the eyes treated with Sunrise Technologies' Hyperion laser thermal keratomileusis (LTK) system for hyperopia in clinical trials were under-corrected by greater than 1.00 diopter twenty-four months post-treatment, data contained in the firm's premarket approval application showed.
Device Week, 4 December 2020 – MedWatch Question About Third-Party Servicers Slides Under Industry's Radar
On this week’s podcast: A change made by the US FDA to its MedWatch program that asks adverse event reporters whether a third party serviced a malfunctioning medical device went unnoticed by many in industry for nearly a year. We explain why, and tell how the servicer question will be helpful for manufacturers and the agency.
The series D financing will support the expansion of Everlywell’s consumer lab testing and digital health businesses.