Vena Medical recently announced it has received regulatory clearance from the US Food and Drug Administration (FDA) for the use of its flagship technology, the Vena MicroAngioscope system, in the peripheral vasculature.
According to the company, the Vena MicroAngioscope system is the world’s smallest camera for a live, full-colour view from inside the vasculature.
“This landmark regulatory achievement opens the door for international exporting, beginning with entry into the USA, the largest peripheral vascular market in the world with 2.5 million procedures annually,” Vena Medical notes in a press release. “It marks Vena’s most significant commercial expansion to date and the opportunity to impact patient care at meaningful scale.”
To support this commercial expansion, Vena Medical simultaneously celebrated the grand opening of its new US$4.5 million Manufacturing Centre of Excellence in Kitchener, Canada. The facility, made possible through strategic funding from the Life Sciences Scale-Up Fund (LSSUF), was officially unveiled with a ribbon-cutting ceremony led by the Honourable Vic Fedeli, Ontario’s Minister of Economic Development, Job Creation and Trade.
