We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, as the stricter requirement could lead to lost sales, AdvaMed says. Read More
In an effort to deepen Ohio’s biotech footprint, a state economic development initiative is pouring more $12.8 million into cutting-edge biomedical companies, startups and entrepreneurs to support innovation in the state. Read More
Medtech sponsors should balance the need to demonstrate safety and efficacy with the potential risks to patients when determining the size and duration of a clinical trial, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
The FDA will soon begin identifying candidates for a pilot program whereby manufacturers can opt to self-identify and correct possible regulatory violations and avoid FDA inspection. Read More
Sharplight Technologies, an Israeli maker of powered surgical lasers, received an FDA warning letter for failures with quality records and other documents. Read More
AtriCure is paying $34 million in stock for California surgical ablation devicemaker Estech, giving the Ohio-based company added clout in the atrial fibrillation market. Read More