Noninvasive CAD staging system receives FDA breakthrough device designation
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Key takeaways:
- A noninvasive imaging-based CAD staging system has received FDA breakthrough device designation.
- The system was also accepted into the FDA’s Total Product Life Cycle Advisory Program Pilot.
Cleerly has received FDA breakthrough device designation for its coronary artery disease staging system, which was also accepted into the FDA’s Total Product Life Cycle Advisory Program Pilot, according to a company press release.
The CAD staging system is a noninvasive imaging-based software device that analyzes features of atherosclerosis, stenosis and ischemia and is designed to improve accuracy and personalization of risk assessment.
The breakthrough device designation is intended to expedite the development and review of devices intended to treat a serious condition in which preliminary clinical evidence indicates potentially substantial improvement over available devices.
Further validation of the system will be assessed in the TRANSFORM trial of asymptomatic patients with diabetes, prediabetes or metabolic syndrome, according to the release.
“As Cleerly continues to develop cardiovascular innovations to support patients and health care professionals, we are honored to have received breakthrough device designation and join the [Total Product Life Cycle Advisory Program] Pilot,” James K. Min, MD, founder and CEO of Cleerly, said in the release. “This designation from the FDA highlights the critical need for better heart disease risk assessment methods. Our approach to heart disease, inspired by the most successful preventive care paradigms in medicine — including mammograms, colonoscopies and lung CTs — enables personalized diagnosis and risk assessment and exemplifies our commitment to enhancing CAD evaluation, aiming to prevent heart attacks before they occur.”
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