Devices

LifeWatch Gains Clearance on Vital Signs Monitor

FDA has cleared a LifeWatch AG 510(k) for its continuous Vital Signs Monitoring Service, a wireless patch intended to allow for early detection of vital sign changes. Notifications on vital sign changes can enable faster interventions as well as increased nursing efficiency and higher patient satisfaction, according to the company.

The device is a cable-free sensor worn on a patient’s upper chest. It is intended to be used on adult patients in a clinical environment for the continuous, non-invasive monitoring of ECG, heart rate, respiration rate, surface temperature, arterial blood oxygen saturation and body position. It will be available in two versions (with and without ECG) and it is connected through a wireless supporting system. “Although the system will initially be used in a medical facility (hospital, nursing home, etc.), the even larger ambulatory market should follow once the technology has been proven in the clinical environment,” 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