Ionic Health gains FDA 510(k) clearance for nCommand Lite

GE HealthCare announced that its Brazil-based partner Ionic Health received FDA 510(k) clearance for its nCommand Lite, which provides diagnostic imaging centers with real-time scanning, remote guidance and operational support, and the ability to view/review images remotely. 

Ionic’s software interacts with equipment like a local technician, enabling remote operation of MRI, CT and PET scans with the same effectiveness and precision. The technology is designed for low bandwidth consumption and can utilize multiple scanners. 

With 510(k) clearance, nCommand Lite is now available to go to market in the United States. 

Brazilian company Ionic Health aims to expand adoption in more regions through a partnership with GE HealthCare. 

“GE HealthCare is committed to continued investment in the rapidly growing space of remote operations through innovation and strategic collaborations that support the current and future needs of healthcare institutions. Our goal is to provide remote operations solutions that lead to increased access for patients, including patients who may require complex care and support from an off-site expert technologist,” Rekha Ranganathan, senior vice president and general manager of imaging platforms and digital solutions at GE HealthCare, said in a statement. 

THE LARGER TREND

GE HealthCare will be the distributor for Ionic’s nCommand Lite solution, which is in alignment with an exclusive distribution agreement made in November 2023.

The medical equipment manufacturer has received several 510(k) clearances, including in the imaging market.

In May 2023, the company received clearance for its deep-learning imaging processing software called Precision DL. The software improves screening time, enhances image quality and increases small lesion detection.

In August, GE HealthCare was given clearance for a smartphone-sized device for monitoring patient respiration rate. The device allows for continuous vital sign monitoring from home. 

The healthcare company received FDA clearance for Novii+, a maternal and fetal monitoring platform, in February. Novii+ allows for continuous patient monitoring during high-risk pregnancy. 

GE Healthcare acquired CT interventional guidance company IMACTIS in 2023 as the newly spun-off company’s first acquisition. The company also acquired AI-enabled ultrasound software producer Caption Health in 2023.