Digital amblyopia therapy released to US market
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NovaSight announced that it is launching CureSight, its digital therapy for amblyopia, to the U.S. market this month.
The FDA granted CureSight 510(k) clearance in October, based on results of a randomized, controlled study that found the device to be noninferior to patching.
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NovaSight also announced in a press release the appointment of Drew Hopper to vice president of sales and marketing North America. He will be instrumental in the launch of the technology.
“We are excited to bring CureSight into the U.S. market and to begin the process of building out our U.S. based commercial capabilities,” Hopper said in the release.
NovaSight said a Physician Early Adopter’s Program, a monitoring center and three CPT codes are available to help clinicians integrate the technology into their practices.
The system is an eye tracking-based digital treatment for amblyopia that trains the visual system to use both eyes simultaneously over the course of 4 to 6 months, Healio reported previously.
Children watch streaming content of their choice on an eye tracking-based device at home, according to the release. Eye care providers can view treatment reports and monitor patient progress and compliance via a web portal.
The company explained in the press release that the early adopters can begin referring their patients to CureSight this month. In the first half of 2023, the next step of commercialization will involve hundreds of other clinicians already registered for the CureSight referral program.
NovaSight is aiming to obtain coverage from the top five U.S. insurance payers in 2023, the company said.
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