FDA granted a De Novo clearance to HemoSonics' point-of-care device for assessing coagulation status, the company said Wednesday.
HemoSonics developed the device, Quantra QPlus, to enable physicians to deliver timely information on a range of blood properties during cardiac surgeries and other procedures.
The device will compete with products including Instrumentation Laboratory's ROTEM and Haemonetics' TEG, which use different mechanisms to deliver similar data.
Physicians manage the risk of hemorrhage in cardiac surgery and other procedures by using devices to glean information about factors such as coagulation. Devices including Haemonetics' TEG and Instrumentation Laboratory's ROTEM use different methods to provide this information with some success.
HemoSonics thinks further improvements are possible. Whereas ROTEM detects changes in clot firmness mechanically, HemoSonics' Quantra applies ultrasound pulses to samples, captures the returning signals and analyzes them to characterize changes in the properties of the blood. Studies have found correlations between the results generated by these different approaches.
The popularity of ROTEM and TEG rests, in part, on their ability to generate information on multiple parameters relevant to surgeons from whole blood samples at the point of care. Quantra has similar selling points but HemoSonics thinks it has features that give it an edge.
HemoSonics' device generates data on a wider range of parameters than competing devices and does so within 15 minutes, around one minute of which requires the hands-on involvement of a healthcare professional. HemoSonics sought to reduce hands-on time by developing an automated, closed, cartridge-based system.
Rival tests can provide an early, reasonably reliable readout in under 15 minutes but take longer to deliver the final results. HemoSonics thinks the potential for its device to save time will lead to better outcomes.
"Faster results can mean better management of critical bleeding, more cost-effective treatment and ultimately better outcomes for patients," HemoSonics CEO Timothy Fischer said in a statement.
The De Novo decision clears HemoSonics to start making this pitch to physicians in the U.S. The device previously received a CE mark and came to market in the European Union.