The submission of the PM1 Pachymeter for FDA 510 (k) approval represents a critical milestone in launching the PM1 in the US market. A 510(k) is a premarket submission made to the FDA (Food & Drug Administration) to demonstrate that the device to be marketed is safe and effective.
To achieve this important milestone, Occuity has delivered a robust technical file for the PM1, which includes the historical evidence, build records and compliance traceability that is necessary to ensure that a new product is both safe and fulfils a clear clinical need.
The submission documents were a collaborative effort involving many members of the Occuity team. However, it's important to acknowledge the exceptional contributions of Sharon Branch, our Head of Operations, who led the project, and Ben Tomlinson, the final reviewer and the driving force behind the ultimate submission. Ben, an experienced EU MDR Quality Engineer, played a pivotal role in ensuring Occuity's full compliance with all the essential regulations and standards.
On this development, Occuity CEO and co-founder, Dan Daly said, "We are excited to have achieved this significant milestone and are very proud of the hard work and dedication of our team. The submission is now with the FDA review team, and we eagerly await final approval to kickstart PM1 Pachymeter sales in the US market within which we are already in advanced discussions with potential distributors”.
Sharon Branch, Head of Operations, further commented:
"Our 510(k) submission was a great achievement and testament to our team's commitment to delivering the highest quality product while complying with all necessary regulations and standards. We are confident in our strong position and eagerly anticipate the opportunity to sell our PM1 Pachymeter in the US."
The PM1 Pachymeter is a groundbreaking device that uses Occuity's patented technology to measure the thickness of the cornea, a crucial element in the diagnosis of eye diseases such as glaucoma and keratoconus. Unlike traditional methods, the PM1 Pachymeter is non-invasive, hand-held, painless, and can be performed in a matter of seconds.