JustRight Surgical said today it won FDA 510(k) clearance for its JustRight 3mm pediatric surgery vessel sealing system.
The Boulder, Colo.-based company touted the win as the 1st and only from the FDA for an electrosurgical device designed specifically for pediatric patients.
“Pediatric surgeons have been requesting ‘right-sized’ surgical instruments and technologies for years. This pediatric indication for use of vessel sealing is the 1st of its kind. It further validates the truly unique technical advancements made by our development team. We are the only surgical device manufacturer to focus solely on pediatrics. Now surgeons and hospitals are recognizing the value we bring to caring for the smallest of patients,” CEO Russ Lindemann said in prepared remarks.
Data from testing of the device which was used in achieving regulatory clearance of the device was presented at the Society of American Gastrointestinal and Endoscopic Surgeons clinical congress in May, the company said.
The sealer is designed for use in extremely tight or small spaces found in teens, children, infants and neonates, JustRight said. The device allows for the permanent fusing of vessels, with low energy use designed to be safe for smaller patients.
In February, JustRight Surgical said it raised a total of $11.2 million in a Series B debt-and-equity round for its surgical stapler and sealing devices.
The Series B round, including $4.2 million in equity and $7 million in debt financing, is earmarked for furthering the U.S. and European commercialization of the company’s devices.
Founded in 2010, JustRight won 510(k) clearance from the FDA for the JustRight 5mm stapler in February 2014, billing it as “the smallest classic stapler on the market.” The company raised a $7.5 million round later that year, adding to the $10.5 million it drummed up in 2013.