San Diego-based Clarify Medical has received FDA 510(k) clearance for its core technology, a handheld, smartphone-connected phototherapy device for treating various skin conditions.
“This is a major milestone,” CEO James M. Sweeney said in a statement. “We look forward to offering Clarify Home Light Therapy to patients throughout the country, beginning in November. It offers an in-office therapy proven effective with skin diseases such as psoriasis, vitiligo, and eczema in a convenient form.”
The device can deliver narrow-band ultraviolet light, a treatment that has been studied and proven effective for certain skin conditions. Users need to have a prescription from their doctor to use the device, and the technology can connect a patient to their doctor, allowing the doctor to follow treatment progress as well as set a treatment schedule for the patient.
Clarify is set to begin shipping its handheld device in November. Customers can get the device for a $799 upfront payment, or can pay monthly installments as little as $25 per month. An additional $10 per month covers support from a Clarify Care Partner.
"We have completed a very successful digital reservation campaign, inviting people with psoriasis and vitiligo to make a reservation for the Clarify system after we received FDA clearance,” Sweeney said. “Patient response was extremely positive. We quickly received a thousand confirmed reservations, and are now in the process of turning those reservations into orders.”
The device itself is very simple: it can be operated with a single button, and a Bluetooth connection with a smartphone ensures the settings are correct while also giving the patient treatment instructions on a screen on the device. In the event of any uncertainty or confusion, the patient can contact their care partner via the app.
“For people with chronic skin conditions that respond to light therapy, the ability to receive medically supervised treatment when and where it is most convenient is a truly life changing development,” Clarify Chairman of the Board David F. Hale said in a statement. “We anticipate strong demand.”