GE HealthCare topped a list of AI-enabled medical devices to receive 510(k) clearance by the U.S. Food and Drug Administration (FDA) this year, at 72.
The company noted that the cleared devices include some from recently acquired companies BK Medical, Caption Health, and MIM Software, such as the following:
- Precision DL – deep learning-based image processing software engineered to provide increased small, low-contrast lesion detectability compared to the company’s conventional Time-of-Flight PET/CT scanner.
- Contour ProtégéAI+ (MIM Software) – software that automatically generates contours for radiation oncology treatment planning, which may reduce simulation to treatment times.
- Caption Interpretation Automated Ejection Fraction Software (Caption Health) – this processes previously acquired transthoracic cardiac ultrasound images, stores and manipulates them, and makes measurements on images to provide automated estimations of left ventricular ejection fraction, which can assist clinicians in cardiac evaluations.
- bkActiv (BK Medical) – this provides high-resolution images with anatomical details for visualization of structures and performing surgical procedures and includes Prostate Volume Assist to generate prostate volume measurements.
This is the third consecutive year that GE HealthCare has topped the list, the company noted.
