Hemodynamic monitoring company LiDCO announced on Wednesday that it was granted clearance from the US Food and Drug Administration (FDA) under Section 510(k) of the Food, Drug and Cosmetic Act to market its new advanced hemodynamic monitoring platform LiDCOunity v2.
The AIM-traded firm said the US dynamic hemodynamic monitoring market was experiencing "significant growth" and was estimated to currently be worth in excess of $100m per annum.
LiDCO's US expansion plans were said to be progressing in line with expectations, with phase one now complete.
The clearance by the FDA meant the company could now accelerate its commercial launch activities, the board explained in its announcement.
It said the new LiDCOunity v2 monitor incorporated LiDCO's high usage programme software, which it said was a differentiated offering aimed at gaining market share in the world's largest hemodynamic market.
The new slim widescreen monitor platform, LiDCOunity v2, reportedly incorporated the core value proposition of combining the full suite of LiDCO technology into one offering.
LiDCO said the new monitor brought together LiDCO's non-invasive, minimally invasive and calibrated technologies, and enabled continuous hemodynamic monitoring, including monitoring of level of consciousness across the entire clinical pathway in one monitor.
In addition, it said it had a number of new additional features, such as an updated graphical user interface with a "more intuitive" menu system, internal battery for transportation and new clinical guidance protocols to aid users.
"The clearance by the FDA means that medical institutions within the United States now have the opportunity to benefit from the next generation of hemodynamic technologies, as well as having access to LiDCO's high usage pricing programme," said chief executive Matt Sassone.
"This is key to establishing LiDCO technology as a standard of care and gaining market share in the world's largest hemodynamic monitoring market."
Sassone pointed out that the announcement coincided with the conclusion of the first wave of its investment in additional US commercial resources, more than doubling the company's presence in the market.
"We look forward to what will no doubt be an exciting period ahead for LiDCO in the United States."