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FDA clears HemoSonics’ remote viewer bleeding-management software

September 9, 2020 By Nancy Crotti

HemoSonics’ Quantra (Image from Hemosonics)

HemoSonics announced today that its Quantra desktop remote viewer software has received 510(k) clearance from the FDA.

The software enables access to blood coagulation results at the point of care. It works with the Charlottesville, Va.-based company’s Quantra QPlus system, which was designed to offer viscoelastic testing with rapid results, ease of interpretation and intuitive operation. The Quantra desktop remote viewer is a PC application that allows clinicians to see near real-time screens of any Quantra analyzer in their network.

“Managing acute bleeding in perioperative situations is a team effort, requiring rapid, accurate hemostasis results,” said HemoSonics president & CEO Bob Roda in a news release. “The Quantra desktop remote viewer enhances the revolutionary point-of-care efficiency of the Quantra system, allowing secure and rapid access to results regardless of where the instrument is located – in the operating room, ICU, or laboratory.”

The Quantra QPlus system, which includes a hemostasis analyzer, QPlus cartridge, Level 1 and 2 quality controls, and now the remote viewer software, is cleared for sale in the U.S. The Quantra system and its QPlus and QStat cartridges, respective quality controls and remote viewing software are commercially available in Europe and certain other countries. In the U.S., the QStat cartridge is available for investigational use only.

 

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