Rongtao Medical Releases Cybersecurity Framework for Legacy Ultrasound Systems

Rongtao Medical has published a framework to assess legacy ultrasound systems' cybersecurity needs, focusing on whether to patch, segment, isolate, or replace them. The analysis indicates that 90.1% of cleared ultrasound designs were approved before the 2023 cyber-device statute. The report highlights that many CISA advisories regarding ultrasound products had incomplete patch coverage. It emphasizes that hospitals should not wait for safety signals before deciding on system dispositions. The report also notes a lack of cybersecurity-related adverse event reports in ultrasound systems since 2019. Frank Zhu, General Manager of Rongtao Medical, stated that hardware and software support timelines are separate, necessitating independent service strategies. The framework is based on FDA clearance records, CISA advisories, and OEM support notices.

Key Points: • 90.1% of ultrasound systems cleared predate the 2023 cyber-device statute. • CISA advisories show incomplete patch coverage for ultrasound product lines. • Zero adverse-event reports related to cybersecurity have been filed for ultrasound systems since 2019.