OSLO, Norway, April 13, 2026 /PRNewswire/ — Photocure ASA (OSE: PHO) today announced that the U.S. Food and Drug Administration (FDA) has communicated to Photocure that it plans to issue a proposed order to reclassify diagnostic endoscopic light source systems (FDA Product Code OAY) under its own initiative per Section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.
This information was shared with Photocure as part of its ongoing dialogue with the FDA, following the Reclassification Petition submitted by Karl Storz SE & Co. KG and addressed in Photocure’s press release of 28 March 2026. Consistent with FDA’s response to the Reclassification Petition, which did not preclude the agency from reclassifying on its own initiative, and subject to internal processes, FDA intends on issuing a proposed order to reclassify FDA Product Code OAY in the second half of 2026. Any potential reclassification will proceed through the FDA’s established processes, with final determinations made by the agency.
For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: ds@photocure.com
Erik Dahl
CFO
Photocure ASA
Tel: +47 45055000
Email: ed@photocure.com
Priyam Shah
Vice President Investor Relations
Tel: +17176815072
Email: priyam.shah@photocure.com
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no
About Photocure
Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com/news.
This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This stock exchange announcement was published by Tolv Hillestad, Photocure ASA, on 13 April 2026 at 08:30 CEST.
This information was brought to you by Cision http://news.cision.com.
The following files are available for download:
View original content:https://www.prnewswire.com/news-releases/photocure-asa-update-on-regulatory-classification-for-oay-equipment-302740263.html
SOURCE Photocure
