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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 Authorizes Marketing of New Implant to Repair a Torn ACL

    FDA Authorizes Marketing of New Implant to Repair a Torn ACL

    U.S. Food and Drug Administration Authorizes Marketing of New Implant to Repair a Torn ACL | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 16, 2020) Today, the U.S. Food and Drug Administration granted marketing authorization—under the De Novo premarket review pathway—for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture. “Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon...
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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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  • U.S. Food and Drug Administration Allows Marketing of First Self-fitting Hearing Aid Controlled by the User

    U.S. Food and Drug Administration Allows Marketing of First Self-fitting Hearing Aid Controlled by the User




    (October 5, 2018) - - The U.S. Food and Drug Administration (FDA) today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider. “Hearing loss is a significant public health issue, especially as individuals age,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. “Today’s marketing authorization provides certain patients with access to a new hearing...
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  • U.S. Food and Drug Administration Permits Marketing of Artificial Intelligence Algorithm for Aiding Providers in Detecting Wrist Fractures

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




    (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...
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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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  • U.S. Food and Drug Administration Allows Marketing of Test to Identify Organisms that Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results

    U.S. Food and Drug Administration Allows Marketing of Test to Identify Organisms that Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results




    February 27, 2017


    Washington, DC - - (February 23, 2017) - - The U.S. Food and Drug Administration (FDA) today allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about which antibiotics the organism is likely to respond to (antibiotic sensitivity). The test also reduces the amount of time it takes to provide this important information, which can guide antibiotic treatment recommendations more quickly. "By identifying organisms and knowing earlier which antibiotics the organism is likely to respond to, health care professionals can treat patients with bloodstream infections more appropriately," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro
    ...
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  • U.S. Food and Drug Administration Allows Marketing of Test to Identify Organisms that Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results

    U.S. Food and Drug Administration Allows Marketing of Test to Identify Organisms that Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results




    February 27, 2017


    Washington, DC - - (February 23, 2017) - - The U.S. Food and Drug Administration (FDA) today allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about which antibiotics the organism is likely to respond to (antibiotic sensitivity). The test also reduces the amount of time it takes to provide this important information, which can guide antibiotic treatment recommendations more quickly. "By identifying organisms and knowing earlier which antibiotics the organism is likely to respond to, health care professionals can treat patients with bloodstream infections more appropriately," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro
    ...
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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 Authorizes Marketing of New Implant to Repair a Torn ACL
    by Staff Reporter 1
    U.S. Food and Drug Administration Authorizes Marketing of New Implant to Repair a Torn ACL | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 16, 2020) Today, the U.S. Food and Drug Administration granted marketing authorization—under the De Novo premarket review pathway—for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture. “Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon...
    12-17-2020, 03:06 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
    U.S. Food and Drug Administration Allows Marketing of First Self-fitting Hearing Aid Controlled by the User
    by Staff Reporter 1
    U.S. Food and Drug Administration Allows Marketing of First Self-fitting Hearing Aid Controlled by the User




    (October 5, 2018) - - The U.S. Food and Drug Administration (FDA) today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider. “Hearing loss is a significant public health issue, especially as individuals age,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. “Today’s marketing authorization provides certain patients with access to a new hearing...
    10-06-2018, 11:49 PM
  • Staff Reporter 1
    U.S. Food and Drug Administration Permits Marketing of Artificial Intelligence Algorithm for Aiding Providers in Detecting Wrist Fractures
    by Staff Reporter 1
    U.S. Food and Drug Administration Permits Marketing of Artificial Intelligence Algorithm for Aiding Providers in Detecting Wrist Fractures




    (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...
    05-25-2018, 03:44 AM

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