Ultomics says this milestone marks EchoGo Amyloidosis as the first device enrolled in the FDA’s Total Product Lifecycle Advisory Program (TAP) to achieve marketing authorisation. The device was among 15 breakthrough cardiovascular devices, to participate in the initial pilot launch phase of the FDA Total Product Lifecycle Advisory Program (TAP) which has since expanded with 55 companies currently enrolled.

This clearance makes EchoGo Amyloidosis the first commercially available software-only medical device to facilitate detection of Cardiac Amyloidosis using echocardiography. Requiring a single routinely acquired echocardiographic clip, EchoGo Amyloidosis needs substantially less clinical information to facilitate detection of the disease compared to current approaches.

Ultromics, a spin-out company from the University of Oxford (UK), has expanded its portfolio of FDA-cleared, AI-based Echo diagnostics to include EchoGo Amyloidosis.  

This development, in collaboration with Janssen Biotech, Inc., a Johnson & Johnson Company, and with support from Pfizer, motivated by their continued commitment to expediting the suspicion, diagnosis and clinical outcomes of Light Chain and ATTR Cardiac Amyloidosis, respectively. Janssen supported the development of the device, while Pfizer supported expediting the performance testing and validation ahead of the regulatory submission.