If you or your child have ever experienced ear infections, you know how difficult (and painful) they can be to diagnose and treat with existing procedures and antibiotics.
Today’s guest is Ryan Shelton, CEO and founder of PhotoniCare, whose team has developed TOMi Scope, a non-invasive handheld imaging platform that uses light to see through ear tissue. PhotoniCare’s TOMi Scope looks directly at the disease, not the eardrum.
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Some of the Episode highlights include:
- Middle ear infection is the leading cause of hearing loss, surgeries, and antibiotic use, especially in children.
- Traditionally, an otoscope is used that results in a 50% misdiagnosis rate.
- TOMi Scope looks like the otoscope, but optical coherence tomography (OCT) images of middle ear increase accuracy, eliminate subjectivity and speculation.
- TOMi Scope is simple to use by nurse practitioners, physician’s assistants, and technicians. It’s not anymore complicated than a flashlight or magnifying glass.
- Parents and patients feel helpless due to limitations of standard care for middle ear disease.
- MedTech startups experience challenges, obstacles, successes, and barriers with fundraising, compliance, regulatory, quality, design, and testing.
- Trying to avoid being on FDA’s radar? Embrace the regulatory landscape.
- A picture is worth a thousand words, a prototype is worth a thousand pictures.
Links:
National Institutes of Health (NIH) Grants
15 Steps to Getting Approval for IEC 60601-1
Greenlight Guru True Quality Roadshow 2019
Memorable Quotes from Ryan Shelton in this Episode:
“Middle ear infection is the leading cause of hearing loss, surgeries, antibiotic use, especially in children.”
“TOMi Scope looks directly at the disease, not the eardrum.”
“The Gold standard is an otoscope, which unfortunately has a 50% misdiagnosis rate.”
“The biggest way we’ve funded this company so far has been through NIH grants.”
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