Devices

Medtronic Gets Ventilator EUA

Medtronic says FDA granted an emergency use authorization for its Puritan Bennett 560 ventilator that will soon be available in the U.S. A company statement says it expects the units, currently sold in 35 countries, to be available in the U.S. in May.

Also, Medtronic says it has released a new remote management capability for its Puritan Bennett 980 ventilator to two U.S. hospitals. The remote reportedly allows healthcare workers to adjust ventilator settings outside the intensive care unit, potentially reducing healthcare worker exposure to patients recovering from Covid-19. Medtronic says that if the feature is well received, it will be released to additional hospitals later this month.

The statement says Medtronic currently ships 300 ventilators worldwide each week and should be manufacturing more than 400 later in April and more than 700 ventilators per week by the end of May, with the ultimate goal of more than 1,000 ventilators each week by the end of June.

In addition, the company says, during the week of 3/30 it started publicly sharing design specifications for its PB 560 ventilator to enable participants around the world to evaluate options for rapid ventilator manufacturing at scale to help doctors and patients dealing with Covid-19.

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