Devices

Masimo Acoustic Respiration Sensor for Infants Cleared

FDA has cleared a Masimo 510(k) for the RAS-45, an acoustic respiration sensor for its Rainbow Acoustic Monitor (RAM) for infant and neonatal patients. Previously, RAM was cleared to monitor adult and pediatric patients greater than 10 kg using RAS-125c and RAS-45 sensors. “With clearance of the RAS-45 sensor for infant and neonatal patients, acoustic respiration rate measurement is now, for the first time, possible for patients of all sizes, including neonates, in the United States,” the company says.

RAM continuously measures respiration rate using an adhesive sensor with an integrated acoustic transducer, the RAS-45 and RAS-125c, applied to the patient’s neck area or, for infant and neonatal patients under 10 kg, the chest. “Using acoustic signal processing that leverages Masimo Signal Extraction Technology, the respiratory signal is separated and processed to display continuous respiration rate (RRa) and an acoustic respiration waveform, a visualization of the vibrations caused by the patient’s airflow,” the company says. The acoustic sensor also allows clinicians to listen to the sound of a patient’s breathing, whether at the bedside, through a point-of-care device.

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

Read more

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