IBA expects that the FDA’s 510(k) approval will boost international interest in its Proteus ONE, a next-generation, single-room proton therapy system.
The system is smaller, less expensive, faster to install and includes the latest in targeted proton therapy technologies, including the company’s Intensity Modulated Proton Therapy (IMPT).
The Proteus ONE system has been created to allow more patients access to proton therapy globally.
IBA chief executive officer Olivier Legrain said: "We are delighted to have received marketing authorisation from the FDA for the ProteusONE Compact Gantry.
"This is an exciting milestone for our customers in North America, where the cost of healthcare is a major focus.
"The ProteusONE aligns with the US healthcare trend of providing the highest quality of cancer treatment possible at the best possible price. We are confident that ProteusONE will drive greater momentum in the adoption of this next-generation targeted cancer treatment internationally.
"The approval reaffirms our world-leading position in the delivery of highly targeted, safer cancer treatment solutions.
"We very much look forward to the first patients at the Willis-Knighton Cancer Centre in the US benefitting from our compact proton therapy offering later this year."
IBA has already sold five Proteus ONE systems in Louisiana, US, Nice, France, Taiwan, and two in Japan.
Willis-Knighton Cancer Centre Radiation Oncology director Lane Rosen said: "The complete clearance of the ProteusONE system, installed at Willis-Knighton, is yet another milestone demonstrating how IBA and WKCC partner for progress."
The company said that Proteus ONE is the brand name of a new configuration of the Proteus 235.
IBA is focused on the development of next-generation proton therapy technologies that provide oncology care providers with premium quality services and equipment.
The company’s proton therapy solutions are scalable and adaptable, providing universal full scale proton therapy centres, as well as next-generation compact, single room solutions.