Drugs

4DMedical Lung Imaging Tool Cleared

FDA has cleared a 4DMedical 510(k) for its XV Technology, a patented four-dimensional lung imaging process that is intended to rapidly and automatically analyze any functional lung impairment from a single X-ray. “It provides critical information about the functional and structural state of a patient’s lungs in the treatment of illnesses such as Covid-19, asthma, chronic obstructive pulmonary disease, cystic fibrosis and lung cancer,” the company says. The process uses proprietary algorithms to identify and quantify any functional impairment, and a ventilation report is then generated and sent to the hospital to enable clinicians to determine the most effective treatment. Total time to acquire a diagnostic report is about three hours.

4DMedical describes the device as a software-as-a-service (SaaS) diagnostic tool, which is available through a secure cloud subscription. It is not intended to replace molecular tests as the primary diagnosis method for Covid-19, but instead it provides quantitative support for diagnosis and follow-up examinations for patients with, or recovering from 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