A UK firm has won a partnership with the Cleveland Clinic while another has received FDA 510(k) clearance for its clinical decision support software solution.
P3 Medical was chosen by Cleveland Clinic Ohio’s Cardiothoracic Anaesthesia department to develop an airway device aimed to improve patient safety.
The MK Airway – which is set to be brought to market by 2021 - is an intubating airway consisting of a rigid, non-crushable conduit and bite guard for endoscopic tracheal intubations.
It can be removed from a bronchoscope without disrupting the placement of an endotracheal tube- a complication that can jeopardise the procedure and patient safety.
Adrian Javes, sales director from P3 said: "P3 Medical products are used in operating theatres throughout the world so we were the ideal partner to deliver the hospital’s vision. It has been a fantastic opportunity to work with the Cleveland Clinic on a device that will dramatically change clinical care for patients around the world. It’s a great example of Britain and the US working together to improve global patient care.”
Directed Systems received 510(k) clearance from The U.S. Food and Drug Administration (FDA) for its Hypotension Decision Assist (HDA) software.
The software solution assists anaesthesiologists to manage blood pressure and the cardiovascular system during surgery. It can now be marketed for use in operating rooms across the United States.
Mark Leaning, CEO & Founder said: "We are delighted to receive FDA 510(k) clearance of Hypotension Decision Assist (HDA) which marks a true milestone for Directed Systems as a business. Not only does this allow us to now begin marketing and sales of HDA in the United States, but it is tremendous validation of our Product Development to date."
P3 Medical and Directed Systems are being supported with their US Strategy by the ABHI – a UK based trade association – and are part of ABHI US Accelerator programme in partnership with Dell Medical School.
Paul Benton, managing director ABHI, International, said: “The UK is a world leader in health innovation and digital tech like this really highlights why. It has been great to support P3 and Directed Systems with their US Strategies and to be able to showcase their software to senior US healthcare figures as a cutting-edge examples of British technology.”
