Tele: 561.316.3330
Breaking Medical Device News

Sunday, October 17, 2021
HomeNovaSightNovaSight Announces First-Ever Pivotal Study for Lazy-Eye Digital Treatment Against Gold Standard...

NovaSight Announces First-Ever Pivotal Study for Lazy-Eye Digital Treatment Against Gold Standard Patching

March 16, 2021

NovaSight (Israeli-based) specializes in ground-breaking vision care solutions based on AI and eye-tracking technology, notes they are on track to achieving FDA 510(k) approval for its CureSight™ lazy eye digital treatment device.

This is the first pivotal study of its kind in children against the gold standard patching treatment.

Amblyopia, also known as lazy eye, affects 3% of the population and if left untreated, can lead to acute visual impairment. To date, lazy eye has been treated with the patch, the gold standard for treatment, a method which comes with social stigma and low adherence. As a result, amblyopia can persist into adulthood.

NovaSight CEO Ran Yam explains, “We’re delighted with the initiation of this important trial, key in demonstrating how effective our lazy eye treatment is while being fun and engaging for the patient. Our CureSight™ treatment allows children to enjoy a wide variety of content like TV programs, movies, and social media from home while treating and improving their vision. This is another important step on our journey of bringing revolutionary treatment for lazy eye to children everywhere.”

In addition, NovaSight advises following a previous pilot trial conducted at Sheba Medical Center in 2019 with 20 children, ages 4-15, it was demonstrated that with CureSight™ amblyopia treatment, visual and stereo acuity improved significantly with 95% adherence. At the half-year follow-up, improvements remained stable.

The current trial is recruiting 90 children with amblyopia aged 4 to 9 and is taking place in six different medical centers across Israel, including Sheba medical center, ranked as one of the 10 best hospitals in the world reports NovaSight.

Prof. Tamara Wygnanski-Jaffe, department head of Pediatric Ophthalmology and Strabismus at Sheba Medical Center said, “We often see children diagnosed with amblyopia and have been very frustrated with current treatment options. We are very enthusiastic to be participating in this trial and hope to see positive results from this clinical study, which will build on our previous clinical data and will advance our knowledge in this field. This represents an opportunity to significantly improve patient care and outcomes. Our patients and their parents are very pleased with the possibility of additional improved treatment options.”

CureSight™ is an eye-tracking-based lazy eye treatment targeted towards children and intended to replace the eye patch. The treatment is carried out while the child watches any content of choice while the image undergoes real-time image processing according to the momentary gaze position. Perfectly positioned for telehealth, it treats children from the comfort of home under the remote cloud supervision of the physician. Feedback is provided to caregivers and physicians via the cloud as well as remote real-time monitoring to measure adherence.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy