USA – Vagal nerve stimulator for stroke rehab nabs FDA nod
The first-ever vagal nerve stimulation system for chronic ischemic stroke rehabilitation has received approval through the US Food and Drug Administration’s (FDA’s) most stringent...
USA – Draft Guidance : Transition Plan for Medical Devices Issued Emergency Use Authorizations...
FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19)...
USA – US FDA Cybersecurity Alert: Risks found in medical device software components
The US Food and Drug Administration (FDA) has issued a cybersecurity alert to medical device manufacturers regarding vulnerabilities that have been identified in the...
USA – FDA eases UDI compliance requirements for some low-risk medical devices
The US Food and Drug Administration has exempted low-risk medical devices considered consumer health products from some Unique Device Identification compliance requirements in accordance...
USA – FDA aims to clarify device malfunction summary reporting requirements
In a new draft guidance issued on Thursday, the US Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit malfunction...
USA – FDA okays first-in-world valve to address congenital heart disease
The US Food and Drug Administration (FDA) announced Friday that it approved a first-in-world device to address pulmonary valve regurgitation in patients with some...
USA – Microspheres for knee osteoarthritis get breakthrough status
Varian announced today that it received FDA breakthrough device designation for its Embozene microspheres for treating knee osteoarthritis.
Palo Alto, California-based Varian, a Siemens Healthineers (ETR:SHL) company,...
USA – FDA OKs personal, Bluetooth-enabled ECG device
AliveCor announced the FDA has cleared its credit card-sized personal ECG device capable of delivering medical-grade, single-lead ECGs in 30 seconds...
USA – Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
The need for effective cybersecurity to ensure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and...
USA – FDA acknowledges shortcomings of Pre-Cert pilot in report
The US Food and Drug Administration (FDA) said it needs additional Congressional authority to move forward with its digital health precertification (Pre-Cert) program. While...
