-
The ATLAS System’s acceptance into the U.S. FDA TAP Pilot Program follows its 2024 Breakthrough Device Designation, placing Optheras among a limited number of companies to receive both recognitions.
-
Participation in the TAP Program establishes structured, ongoing engagement with the FDA through the device’s regulatory development and review process
Optheras A/S, a medical device company focused on advancing minimally invasive bladder cancer treatment, announced today that its ATLAS platform (Automatic Targeting Laser Ablation System) has been accepted into the U.S. FDA Total Product Life Cycle (TPLC) Advisory Program Pilot (“TAP Pilot”), administered by the agency’s Center for Devices and Radiological Health (CDRH).
The acceptance, confirmed by the FDA CDRH Office of the Center Director on July 28, 2026, follows Optheras’ request for enrollment in TAP Pilot program for the ATLAS System proposed indications for use covered under its 2024 Breakthrough Device Designation.
“Being accepted into the TAP Pilot gives us a structured, ongoing line of engagement with FDA as we advance ATLAS toward our pivotal trial and regulatory submission. It also provides opportunities for early engagement with Non-FDA stakeholder including patient groups, clinicians, payers and Centers for Medicare & Medicaid Services (CMS) ” said Thomas Alkeskjold, CEO and co-founder of Optheras. “It reflects the strength of the regulatory groundwork our team has built alongside our Breakthrough Device Designation, and it gives us an added layer of alignment with the Agency as we move through the next stages of clinical and regulatory development.”