Devices

Acutus Expands Left-Heart Access Devices

FDA has cleared an Acutus Medical 510(k) for an expanded suite of left-heart access products to include the AcQCross Qx system for use with the TruSeal and FXD delivery system for the Watchman Left Atrial Appendage Closure device. “Gaining access to the left atrium requires physicians to cross the septum, a multi-step process that often involves the exchange of wires and needles while trying to achieve the proper angle and location on the septum,” the company says. “AcQCross is the first and only transseptal system engineered with an integrated needle and dilator to reduce these exchanges.

AcQCross features an assortment of catheters that are length-, diameter- and tip-matched and designed to lock into the hub of market-leading sheaths used in the vast majority of left-heart procedures, including delivery of the Watchman, Acutus says. “With the expanded product offering, physicians can utilize AcQCross with their preferred sheaths during virtually any left-heart access procedure,” it adds.

At the end of April, Acutus announced a definitive agreement to sell its left-heart access portfolio to Medtronic.

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