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Recent clearances and approvals of medical devices include not just new versions of existing products, but entirely different ways to provide care for both complex illnesses and common needs. Read More
This first European Edition of Quick Notes includes a PDUFA date extension for a chikungunya vaccine candidate, NICE approved AI technologies for radiotherapy treatment therapies, Novartis cited for claims made on an Entresto podcast and comments on the EU proposal for compulsory licensing. Read More
BD has received 510(k) clearance for both remediation and return to full commercial operations of its updated Alaris infusion pump system, which was subject to an FDA class I recall in 2020, the most serious type of recall as use of the device may lead to serious injury or death. Read More
The first wireless pulse-oximetry device for infants has received an FDA 510(k) clearance after first receiving a warning letter for selling the device without the agency’s clearance or approval. Read More
New FDA drug approvals in June include new gene therapies for ambulatory Duchenne Muscular Dystrophy and hemophilia A, a treatment for pediatric growth hormone deficiency and the first ever cell therapy for a severe form of type 1 diabetes. Additionally, the FDA approved a new device for skin repigmentation in patients with vitiligo. Read More
Following multiple years of development, the streamlined version of the ClinicalTrials.gov website officially launched Wednesday, providing users with a revised, simplified layout intended to enhance efficiency and usability. Read More
The FDA said this test is an example of the agency’s continued work with test developers that want to market their products beyond emergency use authorities. Read More