Devices

Ultromics Gets Breakthrough Status for AI Device

FDA has granted Ultromics a breakthrough device designation for its artificial intelligence (AI)-supported platform for detecting cardiac amyloidosis. The EchoGo Amyloidosis uses AI to analyze echocardiograms and detect cardiac amyloidosis, a condition caused by abnormal protein deposits in the heart tissue. The process is completed using a single, commonly acquired heart ultrasound.

“The novel technology is designed to address the unmet need for earlier diagnosis of amyloidosis patients, which otherwise may go unnoticed until the disease has advanced, delaying treatment, and adversely impacting patient outcomes,” the company says. “Cardiac amyloidosis is a heterogeneous disease that can be difficult to diagnose, often requiring specialized expertise and testing. The disease is subclassified based on the specific protein involved, with the major subtypes being transthyretin amyloidosis (ATTR cardiac amyloidosis), caused by misfolding of the transthyretin protein, and a rarer form called light chain amyloidosis (AL cardiac amyloidosis), caused by accumulation of immunoglobulin light chains.”

The product module is being developed with data from “several leading clinical collaborators” and support from Janssen Biotech, the company says, and it is intended to run on Ultromics’ EchoGo Platform. It adds that an early 2024 FDA regulatory submission is expected.

In late 2019, FDA cleared an Ultromics 510(k) for its EchoGo Core, which uses AI to automate the analysis and quantification of ultrasound-based heart scans. The device uses AI to calculate left ventricular ejection fraction, left ventricular volumes and automated cardiac strain, Ultromics said at the time. Its AI algorithms were designed using thousands of images from a “carefully curated dataset,” it said.

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