Sphere Medical has received a regulatory sign-off to make its monitoring and diagnostic products, including the Proxima arterial blood analyser, at its manufacturing facility in Harston, near Cambridge, U.K., the company notes in a release.
The U.K. company is developing a range of monitoring and diagnostic products to help in patient management. Sphere expects its products to allow near real-time measurement of blood gases, various electrolytes, glucose and drug levels at the patient's bedside. This information can enable faster clinical decision-making and improve patient outcomes, the company notes on its website.
Sphere previously had IS13485 authorization for the design and development of medical devices at the Harston facility, Proactive Investors UK notes.
"The successful completion of the audit and certification by TÜV SÜD, our notified body, validates the excellent quality management system which we have at Sphere Medical. This scope extension is an important achievement and underpins our capability for commercial manufacture at our Harston facility," said CEO Stuart Hendry in a statement.