Devices

Don’t Use Uncleared, Unapproved Devices for Concussion: FDA

FDA says it is concerned that products that have not been cleared or approved by the agency are being marketed to individuals, including parents and caregivers, athletic coaches, and healthcare providers, for the assessment, diagnosis, or management of a head injury, including concussion. The agency issued a safety communication “to make the public and healthcare providers aware of the potential serious risks that may be associated with the use of unapproved or uncleared medical devices for the diagnosis, treatment, or management of a concussion.”

The agency says it has identified several manufacturers that were marketing medical devices for concussion diagnosis, treatment, or management without its approval or clearance. “The use of unapproved medical devices may lead to an incorrect diagnosis,” the communication says. “An incorrect diagnosis of ‘no head injury’ after an injury, for example, could lead a person with a serious head injury to return to their normal activities instead of getting medical care. Not getting needed medical care and returning to normal activities could lead to worsening of the injury.”

According to FDA, there are a limited number of medical devices that have been approved or cleared to aid in diagnosis, treatment, or management of head injury, including suspected concussion and other traumatic brain injuries. It also says that it has not approved or cleared any devices that can assess or diagnose a head injury, including suspected concussion and other traumatic brain injuries, without an evaluation by a healthcare provider.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome