PhotoniCare Announces FDA Clearance for First-In-Class Technology for Imaging the Ear

mJOULE Launches in the United Kingdom Reports Sciton

"Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide." says Lacee J. Naik, Vice President of Marketing and Public Relations.

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

Irrimax Receives FDA Clearance for Irrisept

"This new clearance from the FDA further solidifies Irrisept as the market leader in wound irrigation," said Mark Alvarez, CEO of Irrimax.

January 6, 2020

PhotoniCare, Inc., a company dedicated to revolutionizing healthcare by providing healthcare providers with better diagnostic tools, today announced that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for its TOMi™ Scope for non-invasive imaging of the middle ear.

PhotoniCare notes using optical coherence tomography (OCT) high resolution depth imaging, TOMi Scope helps to determine the presence or absence of fluid in the middle ear and to characterize the fluid type.

“Current tools can only provide a view of the surface of the eardrum, forcing healthcare providers to make an assessment with very limited information, or to employ invasive surgical procedures to accurately identify middle ear pathologies,” said Diego Preciado, M.D., Ph.D. of the Children’s National Hospital in Washington, D.C., a lead investigator for clinical studies of the device. “TOMi Scope’s advanced light-based technology could dramatically alter the way children with ear problems are evaluated, enhancing our ability to inform optimal treatments.”

Middle ear infections are the leading cause of hearing loss, surgery and antibiotic use, especially in children. Affecting more than 80% of children, they are misdiagnosed up to 50% of the time using the current gold standard, examination via otoscope.[i] Children can suffer from recurring ear infections for six to 12 months before they are referred to an ENT specialist, and are often prescribed increasingly potent antibiotics during this time. More than one million tube surgeries are performed in the U.S. alone every year.

“Clinicians seeking to be more accurate and confident in their assessment of middle ear fluid and fluid type will find this new technology using light wave detection very helpful,” said Michael Pichichero, M.D., Director of the Rochester General Hospital Research Institute and Research Professor at the Rochester Institute of Technology in New York. “The fact that it works well even in the presence of significant wax build-up is of great value. Wax continues to be a huge problem in middle ear diagnosis.”

“At PhotoniCare we set out to solve the massive problem of frequent misdiagnosis of middle ear infections, and the overuse of antibiotics and referrals to surgery in children that result,” added PhotoniCare co-founder & CEO Ryan Shelton. “We thank the FDA for clearing our TOMi Scope under a new product code unique to our technology, and look forward to bringing this innovation to doctors and patients very soon.”

PhotoniCare expects to immediately launch the TOMi Scope in a limited release in select U.S. geographies, with a full national launch later in 2020.

spot_img

DON'T MISS

Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles