Houston : United Imaging, a global leader in advanced medical imaging and radiotherapy equipment, along with Myocardial Solutions, a medical technology company working to transform the cardiac and cancer care continuum, announced today FDA premarket clearance to market MyoStrain software on United Imaging’s uMR scanners. MyoStrain is a rapid MRI-based heart function test that quantifies the effects of disease, drugs, and ischemia across 48 heart segments in under 10 minutes. It can be used to direct curative cardio-protective therapy to protect the heart without interfering with the cancer treatment during or after cancer therapy.
“While more and more cancers are considered curable today, many available therapies can be toxic to the heart, leading to dysfunction and eventually heart failure,” said Jeffrey M. Bundy, Ph.D., CEO, United Imaging Healthcare Solutions in the U.S. “We believe this new test is a game-changer, providing information that will help oncologists everywhere reduce the risk of their patients developing heart disease due to therapy. Our 1.5T uMR scanners for MyoStrain are currently ready to ship from our Houston-based factory to customers.” United Imaging announced the opening of its factory in late July, just eight weeks after launching uMR OMEGA, a world’s-first 75-cm ultra-wide-bore 3.0T MR system; in short order, both those events and this new partnership have even further cemented its place as a significant U.S. imaging provider.
Heart failure is a common condition and can be often fatal when detected too late. MyoStrain provides a fast, non-invasive way to help doctors detect heart dysfunction before irreversible damage or even heart failure occurs. MyoStrain measures segmental strain to show cardiac effects due to cancer treatment, chronic diseases, and ischemia and allows physicians to monitor heart health over time.
“MyoStrain is the first diagnostic tool that enables physicians to detect the effects of cardiotoxicity early and manage cardio-protective therapy for optimal individualized care,” stated Peter Gaccione, President of Myocardial Solutions. “Our partnership with United Imaging makes a fast, easy, and patient-centric test available for providers and their cancer patients. This announcement marks the next major milestone for MyoStrain following the release of dedicated HCPCS codes from CMS which went into effect on July 1, 2020. Providers can now have access to MyoStrain through United Imaging and can support a cardiac oncology practice with designated Medicare reimbursement.”
“With this joint solution from Myocardial Solutions and United Imaging, oncologists and cardiologists will be able to monitor patient heart health before, during, and after cancer treatment,” said Abram Voorhees, Ph.D., Vice President of MR at United Imaging. “Together, United Imaging and Myocardial Solutions will deliver the diagnostic testing using MyoStrain software on a dedicated MR scanner for both cancer centers and cardiologists. The fast, MR-based technique is highly automated to deliver reproducible results.”
United Imaging is the preferred provider for MyoStrain, and the two companies have joined together to bring this dedicated solution to cancer centers and hospitals. The FDA’s 510(k) premarket clearance of the technology for United Imaging MRI machines marks the availability of this technology for the U.S. market.