Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Sunrise Sets November Date For Hyperion Amended PMA Submission

This article was originally published in The Gray Sheet

Executive Summary

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...

Deficient Long-Term Data Render Sunrise Hyperopia Tool Not Approvable

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.

Everlywell Raises $175M To Expand Consumer Lab Testing, Digital Health

The series D financing will support the expansion of Everlywell’s consumer lab testing and digital health businesses.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts