Devices

UltraSight Ultrasound Guidance Software Cleared

FDA has cleared an UltraSight 510(k) for its artificial intelligence-powered ultrasound guidance technology. The software is intended to assist medical professionals without sonography experience in obtaining cardiac ultrasound images at the point of care in multiple settings. UltraSight says its software will “enable hospital staff to advance patient triage and treatment with increased efficiency and clinical confidence. It can also increase access to care for chronic heart disease patients by bringing cardiac ultrasound into local communities, potentially increasing patient adherence to critical treatments.”

The AI software is indicated for use in two-dimensional transthoracic echocardiography, specifically in acquiring the 10 standard views of the heart. The FDA submission was based on UltraSight’s pivotal study, which “demonstrated that with real-time guidance of the ultrasound probe and feedback on the quality of the ultrasound image, medical professionals without prior ultrasound experience can acquire diagnostic quality images,” the company says.

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

Read more

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