Devices

Alert Update on Vessel Occlusion CADt Devices

An FDA update for healthcare providers has been issued to clarify that the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO) is to triage suspected findings of LVO based on the analysis of brain radiological exams. CDRH says it is working with LVO CADt device manufacturers to ensure that healthcare providers are informed about the intended use and design of these devices. “More generally, because postmarket performance in clinical practice may not match the premarket data, the FDA is also engaged in continuing efforts to evaluate the real-world performance of AI/ML imaging devices, including CADt devices,” the Center says.

As part of the update, a link has been added that references a recent real-world study assessing the clinical performance of certain radiological CADt devices for LVO. The testing of two CADt LVO detection algorithms “identified gaps in the detection and communication of potentially treatable LVOs when considering vessels beyond the intracranial ICA and M1 segments and in cases with absent and uninterpretable data,” the study found.

LVO is an obstruction of one of the large arteries in the brain and is a common cause of acute ischemic strokes. Because the software devices are intended to aid in prioritization and triage of time-sensitive suspected findings of LVO based on the analysis of brain radiological exams, the agency says the devices should not be relied on when making any diagnostic decisions. In addition, “health care providers should ensure that they understand which vessels the device was designed and tested to evaluate. If the device is used for diagnostic decisions or to evaluate vessels for which it was not designed, delayed or missed diagnoses may occur and result in worsened outcomes for patients.”

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