Devices

FDA Accepts Spectral PMA Module for Toraymyxin

FDA has accepted and reviewed a Spectral Medical pre-clinical module for Toraymyxin, an investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream. With acceptance of this module the company says it remains on track to complete its full PMA submission by the end of the year. “This particular section contains key pre-clinical data on the use of Toraymyxin for patients with septic shock, including the device's engineering and bench testing; sterilization and shelf life; packaging and transport details,” Spectral Medical says.

Toraymyxin is a direct hemoperfusion adsorption column that has been shown to be highly effective in removing endotoxin, the company says. Studies have shown that this medical device can remove up to 90% of an endotoxemic patient’s circulating endotoxin when administered twice within a 24 hour period, it says.

In a related event, Spectral has also submitted a separate 510(k) filing for a standalone pump that could facilitate treatment delivery in intensive care units and increase options available to clinicians, the company 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