On September 19, 2022, the FDA granted Advanced NanoTherapies a Breakthrough Device Designation (BDD) for its SirPlux Duo Drug-Coated Balloon (DCB) to treat coronary artery disease. Based on the press...
Mitral regurgitation typically requires a heart valve repair or replacement. Abbott’s MitraClip Clip Delivery System was approved by the FDA in 2013 as a heart valve repair device. However, on...
On September 6, 2022, the FDA shared that Philips recalled specific Philips Respironics masks for BiPAP and CPAP machines. The FDA’s news release shares that these devices have magnets in them,...
A study published in JAMA Network Open observed that tobacco use in younger patients is associated with reduced cognitive function and structural brain changes. Currently, the FDA is working on...
On Monday, July 11, Athos therapeutics announced its plans for a research collaboration with Lahey Hospital and Medical Center in Burlington, Massachusetts, for precision medicine in inflammatory bowel...
A study published this month in the Environmental International Journal found chemical exposure in exceedance of acceptable limits among a group of 98 men, threatening male reproductive health and...
The AMA’s press release urging the FDA to approve over-the-counter sales will revolutionize accessibility to oral contraceptives. Female contraceptives in the United States are offered in...
After obtaining FDA approval on May 31, 2022, the next-generation continuous glucose monitor (CGM) system FreeStyle Libre 3 has garnered another major win for its manufacturer, Abbott.
Clinical data...
The FDA, CDC, and state and local partners have been investigating a recent hepatitis A outbreak potentially linked to fresh organic strawberries in the United States and Canada.
Epidemiologic and...
GE Healthcare will invest up to $50 million in start-up Pulsenmore to accelerate the global adoption of ultrasound solutions and pursue FDA clearance and commercial expansion.
The companies will also...
FDA recently permitted the marketing of the first in vitro diagnostic test for the early detection of amyloid plaques associated with Alzheimer’s disease.
Adult patients aged 55 years and...
A nationwide shortage of baby formula intensified this month, leaving around 31% of stores out-of-stock and prompting the federal government to take action to accelerate production.
Abbott...
Pfizer will open the first United States sites in the Phase 3 study evaluating its investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne...
FDA recently warned the public of the risk of false results, inappropriate use, and interpretation of results with non-invasive prenatal screening (NIPS) tests.
NIPS tests look for signs of...
FDA recently cleared Neurogene’s Investigational New Drug (IND) application for its CLN5 Batten disease gene therapy, NGN-101.
NGN-101 is an adeno-associated virus (AAV) gene therapy and...
FDA recently placed a clinical hold on BioMarin Pharmaceuticals Phase 1/2 trial evaluating its AAV5-phenylalanine hydroxylase (PAH) gene therapy in adults with the rare disease, phenylketonuria...
