First Artificial Intelligence Based Medical Device Permitted for Use by the FDA

Artificial Intelligence Diabetic Retinopathy

With the ever-increasing development of artificial intelligence, there’s no surprise that the medical industry is catching up. In April of this year, the FDA has permitted the marketing and use of a medical device that uses artificial intelligence to detect diabetic retinopathy in adults with diabetes.

Diabetic retinopathy is an eye disease that affects many adults with diabetes. It commonly causes blindness to those living with diabetes and is also the leading cause of blindness and vision impairment among adults. It is caused when high levels of blood sugar damage the blood vessels of the retina. An early detection of retinopathy is essential in further managing the disease. However, according to the FDA, 50% of adults do not see their eye doctor on a yearly basis.

This novel medical device, called IDx-DR, is intended to be used in a primary care doctor’s office to provide a screening decision without the need for an individual to interpret the results or image. The IDx-DR analyzes images of patients’ eyes that are taken by a doctor using a retinal camera. The doctor will then upload the images to a cloud server.

The device’s Artificial Intelligence algorithm will then provide the doctor with one of the following 2 results:

  • Positive – more than mild diabetic retinopathy is detected; refer to an eye care professional
  • Negative – less than mild diabetic retinopathy is present; rescreen in 12 months

For patients that test positive, it is recommended that they should see an optometrist for further diagnostic evaluation and treatment (if needed).

For more information, please do not hesitate to contact Focal Point Research Inc.  We are leading North American Regulatory Consultants for Medical DevicesNatural Health ProductsOTC DrugsCosmetics, and other Consumer Products regulated by the FDA and Health CanadaFrom concept to product launch and beyond, we are scientific consultants with the expertise to put your product safely in the hands of consumers.