FDA clears next-gen hemostasis system from HemoSonics

The Quantra hemostasis system (left) and QStat cartridge (right). [Images courtesy of HemoSonics]HemoSonics announced today that it received FDA 510(k) clearance for its Quantra hemostasis system with the QStat cartridge.

FDA clearance expands the Quantra system’s indications to include trauma and liver transplantation procedures.

Durham, North Carolina-based HemoSonics designed the next-generation system to increase Quanta’s overall diagnostic capabilities. It covers the broadest range of indications of any point-of-care hemostasis analyzer in the U.S., according to a news release.

“The Quantra Hemostasis System with QStat Cartridge is breaking new ground and leading innovation in the point-of-care and laboratory-based whole blood hemostasis testing market,” said Robert Roda, HemoSonics president and CEO. “Today’s clearance significantly expands the clinical indications of the Quantra System, creating the greatest opport…

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  • November 30, 2022
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Key Tech names next CEO as co-founder plans to retire

Key Tech co-founder and CEO Jenny Regan [Photo courtesy of Key Tech]

Key Tech co-founder Jenny Regan plans to retire as CEO of the product development firm at the end of August, making way for VP of Strategy Alex Flamm to take her place.

Regan has been CEO since she and her co-founders launched the Baltimore firm in 1998. The company said it now has 75 interdisciplinary medical product designers and hundreds of clients in the medical technology industry, including Becton Dickinson, GE, Thermo Fisher, HemoSonics, GenMark and Abiomed.

Regan, who led Key Tech’s transition to a fully employee-owned company in 2019, will join the Key Tech Advisory Board.

“I’m incredibly proud of what we’ve built and how much good we’ve been able to do,” Regan said in an announcement posted to the company’s website last week. “I’m confident in our new leadership and will always be inspired by the talen…

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  • March 28, 2022
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