Ivy Biomedical Systems, Inc. - FDA 510(k) Cleared Devices

Ivy Biomedical Systems, Inc. is a privately-held medical device company headquartered in Branford, Connecticut. The company is the market leader for precision cardiac gating monitors used for synchronization of radiographic image acquisition across major imaging modalities including nuclear medicine, computed tomography, magnetic resonance, positron emission tomography, and single photon emission computed tomography.

The company has received 27 FDA 510(k) clearances from 27 total submissions since its first clearance in 1986. Cardiovascular devices represent the dominant focus, accounting for 74% of submissions. Latest clearance in 2024 confirms the company remains actively engaged in FDA regulatory pathways.

Recent cleared devices include cardiac trigger monitors, ECG leads and cables, physiological measurement modules, and patient monitoring systems. These products support diagnostic imaging workflows and cardiac synchronization across clinical settings.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database.