"I have been thoroughly impressed from the moment we first spoke to Haris and the team at Panacea. Their quotes and timelines were an order of magnitude faster and lower cost than others in the market, while their clear communication, regulatory experience and commercial understanding are absolutely first class. I have already passed their details on to friends in my industry and will continue to do so." — QMO, Perlumis Surgery
"I have been thoroughly impressed from the moment we first spoke to Haris and the team at Panacea. Their quotes and timelines were an order of magnitude faster and lower cost than others in the market, while their clear communication, regulatory experience and commercial understanding are absolutely first class. I have already passed their details on to friends in my industry and will continue to do so." — QMO, Perlumis Surgery
The Novelty
Bladder cancer recurs in up to 78% of patients — driven in large part by incomplete tumor resection and poor surveillance — with roughly 84,870 new U.S. cases in 2025. A major reason tumors come back is simple: during a cystoscopy, standard single-frame endoscopy can leave areas of the bladder wall unseen .
Perlumis is changing that. They are developing AI software for urological endoscopy that helps clinicians build a more complete view of the bladder and identify areas that may warrant closer attention during a procedure. The software is designed to augment existing clinical workflows while keeping diagnostic and treatment decisions firmly with the clinician, all on hardware that the clinicians are already familiar with.
Bladder cancer recurs in up to 78% of patients — driven in large part by incomplete tumor resection and poor surveillance — with roughly 84,870 new U.S. cases in 2025. A major reason tumors come back is simple: during a cystoscopy, standard single-frame endoscopy can leave areas of the bladder wall unseen .
Perlumis is changing that. They are developing AI software for urological endoscopy that helps clinicians build a more complete view of the bladder and identify areas that may warrant closer attention during a procedure. The software is designed to augment existing clinical workflows while keeping diagnostic and treatment decisions firmly with the clinician, all on hardware that the clinicians are already familiar with.
The Challenge
A first-of-its-kind AI for urological endoscopy has no clean, off-the-shelf FDA precedent. Perlumis's strategy stitches together a split-predicate 510(k) argument across three cleared devices. But the anatomical-site novelty is the catch, resolving this almost certainly requires a Pre-Submission meeting with FDA before committing to a pathway.
A first-of-its-kind AI for urological endoscopy has no clean, off-the-shelf FDA precedent. Perlumis's strategy stitches together a split-predicate 510(k) argument across three cleared devices. But the anatomical-site novelty is the catch, resolving this almost certainly requires a Pre-Submission meeting with FDA before committing to a pathway.
The Solution
Perlumis partnered with Panacea to accelerate its regulatory strategy without the cost and timelines of a traditional consultancy. Panacea combined experienced regulatory review with AI-native workflows to develop the FDA engagement and submission strategy, de-risk key pathway questions early, and establish a scalable QMS - giving the Perlumis team greater certainty while allowing them to remain focused on building and bringing their technology to patients.
Perlumis partnered with Panacea to accelerate its regulatory strategy without the cost and timelines of a traditional consultancy. Panacea combined experienced regulatory review with AI-native workflows to develop the FDA engagement and submission strategy, de-risk key pathway questions early, and establish a scalable QMS - giving the Perlumis team greater certainty while allowing them to remain focused on building and bringing their technology to patients.