Genetesis Applauds CMS’s MCIT Rule to Provide National Medicare Coverage for FDA Breakthrough Devices

New Pathway will Offer Beneficiaries Access to CardioFlux® for Patients with Symptoms Suggestive of Acute Coronary Syndrome

Partner News | Published: Wednesday, January 13, 2021 4:00 pm

The Centers for Medicare & Medicaid Services (CMS) announced the establishment of the Medicare Coverage of Innovative Technology (MCIT) pathway, to bring new and innovative technologies to beneficiaries sooner. This rule provides four years of coverage for medical devices designated as “breakthrough devices” by FDA. 

Last month FDA designated Genetesis’ CardioFlux® as a Breakthrough Device for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome. CardioFlux® met one of the criteria for Breakthrough Designation by demonstrating the potential for a more effective diagnosis of a life-threatening condition like myocardial infarction.  Genetesis has initiated the market authorization process with FDA and coverage for CardioFlux® can begin on the date when this process is successful.

“The Genetesis team commends CMS on the finalization of MCIT; this final rule provides Medicare beneficiaries with access to potentially lifesaving technologies like CardioFlux® in a more time-sensitive manner than ever before,” stated Peeyush Shrivastava, Co-Founder and CEO, Genetesis.

“We appreciate this opportunity to work collaboratively with both FDA and CMS to improve the prognosis and quality of life of patients. Accordingly, we are thrilled that the MCIT pathway will accelerate access of CardioFlux® in emergency rooms throughout the country.”





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