Devices

FDA Updates Phillips Trilogy Ventilator Corrections

FDA has issued an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that could cause serious injury or death if the devices are not updated. The action affects several ventilator models in the Trilogy Evo platform, including the Trilogy Evo, Trilogy EV300, Trilogy Evo O2 and Trilogy Evo Universal devices manufactured by Philips.

Unlike a product removal, the action involves software corrections and updated instructions for use rather than pulling the devices from hospitals or patients’ homes. FDA said Philips has advised customers to update all affected ventilators to software version 1.05.15.00 before continued use and to review revised user manual guidance.

Philips first notified customers on 3/2 and later issued updated guidance on 4/24 concerning nebulizer use with the ventilators.

According to FDA, Philips identified three separate issues affecting the ventilators, primarily involving nebulizer use, internal flow sensor contamination and delayed obstruction alarms.

The affected ventilators are used to provide continuous and intermittent positive airway pressure breathing support for pediatric and adult patients requiring mechanical ventilation in hospitals, healthcare facilities, during patient transport and, for some models, in home-care settings.

As of March 6, Philips had reported three serious injuries related to the issues and no deaths, according to FDA.

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

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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