Devices

SonarMed Recalls Airway Sensors

SonarMed is recalling its SonarMed Airway acoustic sensors due to a restricted inner diameter of the device resulting in difficulty passing a suction catheter through the sensor (2.5mm, 3.0mm, and 3.5mm). “Use of the affected SonarMed Sensors may cause serious adverse health consequences, including delays in treatment, low oxygen levels (hypoxia), air leaking into the chest cavity (pneumothorax), not enough air reaching the lungs (hypoventilation), harm to the tissues, slow heart rate (bradycardia), or even breathing problems leading to respiratory failure,” a recall notice says. To date, there has been one reported injury and no reports of death.

The SonarMed airway monitoring system is used with patients on ventilators and comprises a SonarMed monitor that is used along with a single-patient use SonarMed Sensor, connected via an external cable, and software that operates the Monitor and Sensor, the notice says. The device is intended to support the management of artificial airways in hospital settings such as intensive care units, operating rooms, emergency departments, and during intrahospital transport.

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