Visibly Becomes First FDA-Cleared Online Vision Test in the United States
I am so excited to announce that the Visibly Digital Acuity Product (VDAP) is now FDA 510(k) Cleared! VDAP is the first online / at-home digital acuity test to ever be cleared by the FDA.?
This milestone didn’t come easily. We failed once. The dream was over. We shut the platform down, let our entire team go, and tried to sell the assets to whoever would take them. No one did.
Then in April 2020 our journey took a different turn as we were able to turn the platform back on thanks to FDA’s Enforcement Policy for Remote Ophthalmic Assessment and Monitoring. We did this thinking that it would only be for a couple of weeks and that we would all officially move on once the initial COVID wave passed. However, it soon became clear that it wasn’t going to pass and that we may have an opportunity for a second chance.?
We raised new capital. Brought back the team. Hired new talent. Engaged with great consultants. And most importantly, got to work attempting to correct our failures. All while knowing failing again was not only highly possible, but expected by many people around our industry.?
We didn’t give in, we fought, we scraped. Through three pilots, hundreds of software changes, and thousands of pages of product documentation, a clinical trial, human factors study, multiple FDA interactions, and a hundred more moments where it felt like it all might come crashing down again, we have built great software that delivers strong clinical results that will allow ECPs to engage with their patients to remotely assess visual acuity in a way that was not available before. It only took 857 days from the time we turned the platform on.
This would not have been possible without the great employees, investors, and consultants around us.
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Thank you Brent Rasmussen for having the confidence to give me the keys to this process and trusting me to bring it to life. You have given me the opportunity of a lifetime and I can’t express the gratitude I have for that.
Thank you to Derek Schaefer , Patricia M. , Ayo Jimoh , and Renato Rangel for answering the call to turn the platform back on in the throes of the pandemic when we had no cash and no way to pay you except a promise from Brent and I to take care of it in the future. Your dedication to this mission and product set the tone for what Visibly has become and I am proud to have accomplished this with you.
Thank you to David Gwizdala , Henry Hamilton Clement , Louie Cordon , Brady Gent, CPA , Austin Eskeberg , Cliff Harshaw, and Jessica Scott-Bush for coming back to chase the dream again after we let you down once before. Your trust in our product and our direction reflects in our successes.
Thank you to Joel Stonedale , Josh Rich , Pann Pichetsurnthorn , Sha Alibhai , Craig Frey, Michael Vader, Victor Ahrin, Justin Snell, Will Bast, and Deb Rostorfer for bringing new energy and ideas to this company. Your willingness to tackle this challenge with us after our past failures and knowing our history helped push us to operate at a new level that was critical to our success.
Thank you to Janice Hogan, Ryan Bouchard, Caitlin Black, Brian Rooks, Andrew Cittadine, Adam Zysk for your guidance in navigating the 510(k) process. This simply does not happen without each of you.
Lastly, thank you to our investors who provided the capital, support, and guidance needed to push this product through the process. Sach Chitnis and Peter J. Carroll at Jump Capital . Salen Churi and Daniel Epstein, J.D., Ph.D. at Trust Ventures . Adam Koopersmith at PGVC. Brian Hirsch at Tribeca Venture Partners . Shmuel Gniwisch at Kli Capital . Rob Chesney at Chicago Ventures . Infocus Capital Partners. Joseph Batcha . Corazon Capital . Monroe Capital Partners.
Experienced Leader in eCommerce & Backend I.T. Product Management
2 年So happy for you guys! Congrats again!
Way to go guys!
Co-Founder & CEO at Adaro Optics Limited
2 年Wow that is a serious rollercoaster ride! Never give up attitude delivered.. great story.
CEO Aloi Capital | Co-Founder KITS | Former Goldman Sachs Private Equity Portfolio Manager
2 年congrats, that's great news!!
Independent Corporate Board Member
2 年Congratulations!