The agency also clarified its description of the Portrait Core Services software issue, which can result in patients being removed from monitoring or alarm settings resetting during software updates.
An analysis finds nine in 10 cleared ultrasound system designs predate the US cyber-device statute—and all four CISA advisories naming ultrasound lines had incomplete patch coverage.
Boston Scientific reports no new unauthorized activity since Aug 25, while new cardiac device remote monitoring activations remain disrupted.
The solution combines a 1.5T MRI platform with MR-compatible mapping, monitoring, and catheter technologies to support radiation-free cardiac procedures.
