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Pulse Medical receives FDA Breakthrough Device Designation for its μFR® system

Monday, May 29, 2023

Pulse Medical Technology, Inc. (Pulse Medical) has achieved a significant milestone with its latest generation μFR® system, receiving Breakthrough Device Designation from the FDA.

Pulse Medical, established in 2015 and headquartered in Shanghai, China, is a renowned developer dedicated to creating innovative technologies for accurate diagnosis and optimal treatment of patients with pan-vascular diseases. One of their notable breakthroughs is the development of the advanced μFR® algorithm, which enables rapid calculation of Fractional Flow Reserve (FFR) using multiple imaging data.

The μFR® system is an angio-based physiologic assessment tool that eliminates the need for pressure wires or hyperemic agents. It offers a broader range of indications and increased affordability compared to traditional methods. The μFR® system can be effectively utilized throughout the entire PCI (percutaneous coronary intervention) procedure, providing accurate physiologic assessment in pre-PCI, optimizing strategies during the operation, assessing outcomes, and evaluating microcirculatory function in post-PCI.

Receiving Breakthrough Device Designation from the FDA signifies that the μFR® system has demonstrated its potential to deliver more efficient treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. This designation streamlines the review process, expediting Pulse Medical's time to market.

"We are delighted that the FDA has granted μFR® Breakthrough Device Designation," said Bing LIU, President of Pulse Medical. "Cardiovascular diseases are a leading cause of global mortality, with millions of deaths reported annually. The μFR® system, as a physiological assessment tool, has the potential to provide clinicians with crucial information, enabling more patients to receive effective and precise treatment."

Clinical tests of the μFR® system have yielded significant benefits. The FAVOR III China representative clinical trial demonstrated a remarkable 35% reduction in the risk of major adverse cardiovascular events (MACE) based on a one-year follow-up. These positive outcomes were published in the reputable medical journal LANCET.

Pulse Medical remains dedicated to advancing the field of pan-vascular interventions, driving the development of intelligent and precise vascular intervention technologies.




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