Devices

FDA Clears Design Changes to Zio AT

FDA has cleared an iRhythm Technologies 510(k) related to prior design changes made to the Zio AT device under a letter to file. A 5/25/2023 Warning Letter noted that the device was cleared for long-term monitoring of arrhythmia events for non-critical care patients where real-time monitoring is not needed as reporting timeliness is not consistent with life-threatening arrhythmias. Marketing materials, the letter said, described different indications with changes to the device that would require a new 510(k) submission. The latest 510(k) clearance addressed those changes.

The prescription-only outpatient cardiac telemetry device includes the Zio AT patch, an ECG monitor that continuously records ECG data for up to 14 days, according to the company. It also features a wireless gateway that provides connectivity between the patch and the Zio ECG utilization software to transmit data during the wear period, and the company’s “deep-learning algorithm” that analyzes cardiac events transmitted by the patch device and gateway, it says.

“The Zio AT services provide event transmission reports during wear and a comprehensive end-of-wear report with preliminary findings to the treating medical professional for final clinical decisions,” iRhythm 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

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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