FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults| site |



(November 6, 2020) - - On November 6, 2020 the U.S. Food and Drug Administration (FDA) published the following information: Today, the U.S. Food and Drug Administration permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The device provides gentle vibration through touch based on an analysis of heart rate and motion during sleep. “Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need. Today’s authorization offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary re...

U.S. Food and Drug Administration Permits Marketing of Artificial Intelligence Algorithm for Aiding Providers in Detecting Wrist Fractures

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(May 24, 2018) - - Today, the U.S. Food and Drug Administration permitted marketing of Imagen OsteoDetect, a type of computer-aided detection and diagnosis software designed to detect wrist fractures in adult patients. “Artificial intelligence algorithms have tremendous potential to help health care providers diagnose and treat medical conditions,” said Robert Ochs, Ph.D., acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This software can help providers detect wrist fractures more quickly and aid in the diagnosis of fractures.” The OsteoDetect software is a computer-aided detection and diagnostic software that uses an artificial...

FDA Permits Marketing of Artificial Intelligence-based Device to Detect Certain Diabetes-related Eye Problems

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(April 11, 2018) - - The U.S. Food and Drug Administration (FDA) today permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. 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. “Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately scre...