Devices

DiA Imaging’s AI Imaging Software Cleared

FDA has cleared a DiA Imaging Analysis 510(k) for its LVivo IQS, a new artificial intelligence-based vendor-neutral software that the company says enables ultrasound users to acquire high-quality, interpretable cardiac images that can be used to make better clinical heart assessments.

The company says high-quality cardiac ultrasound imaging is difficult because of the constant beating of the heart and its deep location in the chest. “DiA’s new LVivo IQS - Image Quality Score provides real-time image quality feedback while scanning the left ventricle of the heart to assess the heart’s performance,” it says, adding that the software uses colors and numerical scoring to tag an image’s quality level as it is being scanned, which helps users to produce “optimal interpretable images.”

The clearance relied on data from a clinical study that demonstrated “high agreement between the LVivo IQS AI’s quality score feedback and the ability to obtain clinically interpretable images as evaluated by cardiologists specializing in echocardiography,” the company says, adding that 91% of images saved by point-of-care residents using LVivo IQS, were found to be clinically interpretable images.

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