Hogan Lovells Advises on Groundbreaking FDA Grant of De Novo Request to Market a Novel Artificial Intelligence-based Device

Philadelphia / San Francisco, 16 April 2018 – IDx LLC, with assistance from Hogan Lovells, achieved a major grant of De Novo classification from the U.S. Food and Drug Administration for the novel artificial intelligence-based device IDx-DR. The product is the first device authorized for marketing that detects disease without the need for a clinician to also interpret the image or results, which makes it usable by health care providers who may not normally be involved in eye care.

IDx-DR detect greater than a mild level of the eye disease diabetic retinopathy in adults. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye. Diabetic retinopathy is the most common cause of vision loss among the more than 30 million Americans living with diabetes and the leading cause of vision impairment and blindness among working-age adults.

Due to its medical importance, the IDX-DR was granted Breakthrough Device Designation by the FDA.

The Hogan Lovells team was led by Janice Hogan and Yarmela Pavlovic, with support from Tammi Huynh and Megana Sankaran.

The de novo clearance was the first such clearance for a device since FDA implemented user fees under MDUFMA IV.  The clearance was obtained in 90 days, which is substantially faster than the average de novo review times, reflecting the expedited review designation and its medical importance.

Of the approximately 200 de novo clearances that have been granted by FDA since the process was created in 1997, Hogan Lovells has supported more submissions than any other entity.  Hogan Lovells has continued to support the innovative and groundbreaking medical technologies of our clients like IDx, with innovative approaches to regulatory approval pathways, fostering rapid approval of breakthrough technologies.

About Hogan Lovells

Hogan Lovells is a leading global legal practice providing business-oriented legal advice and high-quality service across its exceptional breadth of practices to clients around the world. 

“Hogan Lovells” or the “firm” is an international legal practice that includes Hogan Lovells US LLP and Hogan Lovells International LLP. For more information, see www.hoganlovells.com.

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