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MyCardium’s quadruple regulatory cleared cardiac AI platform
MyCardium AI is a rapidly growing UK-based company delivering advanced core-lab services, now with two CE-marked and FDA-cleared AI medical devices - 1CMR Pro and EchoConfidence - built on decades of leading academic research. With Hardian Health as a strategic partner, MyCardium navigated complex regulatory pathways with exceptional speed and success. How did they do it?
Sanome becomes the UK’s first certified AI tool tackling hospital-acquired infections
Sanome has reached a landmark moment with the CE Marking of its AI-powered clinical decision support tool, MEMORI, as a Class IIb medical device. This makes it the first UK-built AI tool certified to tackle hospital-acquired infections—a major step forward for clinical AI and infection prevention.
Rethinking regulation, with Neuronostics
Hardian supported Ross Parkman, Technical Director at Neuronostics, a company on a mission to improve the lives of people with epilepsy to gain their initial CE mark.
How Hardian helped Koios convert their FDA approval to CE marking
The US FDA and the EU MDR, while ostensibly serving the same purpose of vetting and clearing novel medical devices, do so in subtly different ways. What got you here, won’t get you there - learn more about converting from one regulatory system to another.