Devices

FDA Clears Trial Restart of Recurring Stroke Device

FDA has given Nobles Medical Technology II the green light to restart its pivotal clinical trial evaluating the NobleStitch EL system, a device-free, suture-mediated method for closing a patent foramen ovale (PFO) to reduce recurrent cryptogenic stroke. The trial was paused in 2023 over a protocol update to address observations made by FDA.

In a separate but related matter, the agency in 2024 issued a Warning Letter regarding deficiencies in the company’s monitoring and oversight of clinical studies. The letter cited the firm’s failure to obtain accurate financial disclosure information from investigators, raising concerns about the study's data validity and subject protection.

The company says the trial restart is intended to progress the company’s development program, which aims to demonstrate that PFOs — small openings between the heart’s upper chambers — can be safely and effectively closed without leaving behind a permanent implant.

NobleStitch EL is currently FDA-cleared for cardiovascular suturing and for PFO closure. It is manufactured and distributed by HeartStitch.

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