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  • FDA authorizes Marketing of new Device designed to remove Dead Pancreatic Tissue

    FDA authorizes Marketing of new Device designed to remove Dead Pancreatic Tissue

    U.S. Food and Drug Administration authorizes Marketing of new Device designed to remove Dead Pancreatic Tissue | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 23, 2020) Today, the U.S. Food and Drug Administration authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially deadly condition which can occur several weeks after an episode of severe acute pancreatitis, often requiring tissue removal. “This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled-off pancreatic necrosis, which occurs in about 15 percent of patients with severe pancreatitis,” said Charles Viviano, M.D., Ph.D., acting director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the FDA’s Center for ...
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  • 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...
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  • FDA Permits Marketing of Artificial Intelligence-based Device to Detect Certain Diabetes-related Eye Problems

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



    (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...
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  • Staff Reporter 1
    FDA authorizes Marketing of new Device designed to remove Dead Pancreatic Tissue
    by Staff Reporter 1
    U.S. Food and Drug Administration authorizes Marketing of new Device designed to remove Dead Pancreatic Tissue | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 23, 2020) Today, the U.S. Food and Drug Administration authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially deadly condition which can occur several weeks after an episode of severe acute pancreatitis, often requiring tissue removal. “This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled-off pancreatic necrosis, which occurs in about 15 percent of patients with severe pancreatitis,” said Charles Viviano, M.D., Ph.D., acting director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the FDA’s Center for ...
    12-24-2020, 10:08 AM
  • Staff Reporter 1
    FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults
    by Staff Reporter 1
    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...
    11-08-2020, 05:54 AM
  • Staff Reporter 1
    FDA Permits Marketing of Artificial Intelligence-based Device to Detect Certain Diabetes-related Eye Problems
    by Staff Reporter 1
    FDA Permits Marketing of Artificial Intelligence-based Device to Detect Certain Diabetes-related Eye Problems



    (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...
    04-12-2018, 08:28 PM

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