Devices

Phillips Resumes Making Defibrillators Under Consent Decree

FDA has asked a Massachusetts federal court to lift portions of a consent decree affecting Royal Philips and its Emergency Care and Resuscitation business to allow the company to resume manufacturing and shipping external defibrillators for the U.S. market. The 11/2017-ordered decree (see earlier story) suspended external defibrillator manufacturing at its Andover, MA, and Bothell, WA facilities. The decree followed inspections in 2015 and before that documented GMP issues, according to the company.

Earlier in 2017, Phillips recalled its HeartStart MRx Monitor/Defibrillator due to battery and electrical issues. The device is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to those with sudden cardiac arrest. An FDA recall notice said that the battery and electrical connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. The device may also unexpectedly stop pacing. “A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death,” the notice said.

Under the decree, defibrillator manufacturing was to cease until FDA certifies through inspection the facilities’ compliance with the Quality System Regulation. The decree allowed Philips to continue the manufacture and distribute certain automated external defibrillator models. Philips says it continues to comply with the terms of the consent decree, which remains in effect, and includes ongoing regulatory compliance monitoring and facility inspections of the defibrillator business and of Philips’ other patient care businesses by 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

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