Creo receives FDA clearance for new product
Creo Medical Group has received US Food & Drug Administration (FDA) clearance for a new endoscopy device.
It is the first in a number of expected regulatory clearances for a suite of new devices from the Chepstow-headquartered company.
“We are delighted to receive FDA clearance for our HS1 Haemostasis device, which is the first deployment of our unique non-stick haemostasis technology,” said Creo chief executive Craig Gulliford.
“The engineering team have worked incredibly hard for the last couple of years to get to this point with the HS1 device.
“They continue to work hard to close out regulatory clearances for our entire suite of advanced energy surgery products for the flexible endoscopy markets.”
Creo is also seeking ways to make its team of medical experts available to assist the NHS in managing the ongoing Covid-19 outbreak.
Charles Spicer, chairman, added: “I would like to congratulate Craig, Chris, Rich and all the team for achieving FDA clearance for our second key device so efficiently.
“This follows a period of enormous effort and excellent teamwork leading into the substantial disruption of Covid-19.
“We have a cogent plan to manage the business during these uncertain times.
“The board want to thank our colleagues, our customers, and our suppliers for all their support and, of course, wish them and their families the best of health.”