iHealthScreen gets FDA 510( k) for AI-enabled eye screening system

iHealthScreen, maker of AI-enabled software application for retinal imaging, got FDA 510( k) clearance for its iPredict Eye Screening System that leverages AI to assist service providers identify if a client over 50 has age-related macular degeneration.

The iPredict System screens for AMD by utilizing AI to examine high-resolution pictures of a client’s eyes taken with a color fundus electronic camera. The test can be carried out in 5 minutes, and outcomes are offered within one minute.

The business is presently fundraising for a pre-Series A round of $5 million.

” This is a significant turning point for iHealthScreen. iPredictTM eye illness diagnostic tools can assist avoid loss of sight for countless individuals and conserve insurance providers many countless dollars in preventable health care expense,” Dr. Alauddin Bhuiyan, creator and CEO of iHealthScreen stated in a declaration.


In 2019, 19.8 million people in the U.S. coped with some kind of age-related macular degeneration, a boost of more than 2.75 times previous quotes, according to a research study in JAMA Ophthalmology

In 2021, iHealthScreen got CE accreditation for its iPredict System for the early medical diagnosis of diabetic retinopathy, glaucoma and age-related macular degeneration. A year later on, the U.S.-based business revealed it got approval from Australian Health’s Healing Item Administration.

Another business using AI to spot AMD is Optain, introduced previously this month by Aegis Ventures and Northwell Holdings, the financial investment arm of the New York-based health system. Optain utilizes AI-backed retinal imaging to capture early indications of the illness using innovation from the Australian business Eyetelligence. The partners supplied Optain with a preliminary seed financial investment of $12 million.

Like this post? Please share to your friends:
Leave a Reply

;-) :| :x :twisted: :smile: :shock: :sad: :roll: :razz: :oops: :o :mrgreen: :lol: :idea: :grin: :evil: :cry: :cool: :arrow: :???: :?: :!: