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Photonicare ISO 13485 Certification

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PhotoniCare Announces ISO 13485:2016 Certification

Champaign, Ill. – December 20, 2021 – PhotoniCare, Inc.—a company revolutionizing frontline care with the OtoSight Middle Ear Scope that uses OCT technology to increase the objective accuracy of fluid assessment in the middle ear—announced that they have successfully completed their ISO 13485:2016 certification today.

ISO 13485:2016 is an internationally recognized quality standard that specifies requirements for a quality management system used by an organization demonstrating its ability to provide medical devices and related services that consistently meet strict regulatory and customer requirements. The Quality Management System PhotoniCare utilizes to design, manufacture, and service OtoSight Middle Ear Scopes has officially been audited and meets all ISO 13485:2016 requirements.

“ISO 13485:2016 is a very prestigious certification to have earned and helps us achieve our goal of being compliant with the US and global laws and regulations of the medical device manufacturing industry. This certification represents the commitment we have to the quality of our product.”

– Heather Hawkes Howard, Director of Manufacturing

I am incredibly proud of our small team for accomplishing something few medical device startup companies achieve. This certification shows our commitment to quality and embodies our core company pillars of Excellence, Empathy, and Innovation.”

– Ryan Shelton, CEO and Co-Founder

About PhotoniCare

Founded in 2013, PhotoniCare’s mission is to revolutionize healthcare by providing physicians better diagnostic tools starting with the [OtoSight Middle Ear Scope]. This is the first and only otoscope to produce non-invasive imaging of the middle ear using a novel application of Optical Coherence Tomography (OCT) to directly visualize and characterize fluid in the middle ear, a necessity for the diagnosis of middle ear infections. PhotoniCare has developed a patented imaging platform that provides growth opportunities beyond otology (study of the ear). Peer-reviewed studies show that the same handheld OCT technology can examine other areas, such as the anterior and posterior segments of the eye, the skin, and the mouth.

PhotoniCare has been recognized by numerous organizations, winning the 2021 Northwest Arkansas Tech Summit Pitch Competition, the 2018 MedTech Innovator Execution Award, and the 2018 AdvaMed Accel Virginia Shimer Rybski Memorial Award. The company was also a member of the 2016 Dreamit Ventures accelerator program and won 1st place at the 7th Annual Insight Product Development 2019 HealthTECH Startup Competition. PhotoniCare has received more than $6 million in support from the National Institutes of Health, most recently a Phase II SBIR award for work in artificial intelligence. In 2015, PhotoniCare was the winner of a grant from the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), an FDA-funded consortium led by Children’s National Hospital.

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