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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.
UCL spin-out achieves double FDA Breakthrough Designation with Hardian
Guided by Hardian Health’s regulatory expertise, UCL spin-out Guildford Street Laboratories (GSL) has achieved a landmark milestone with their blood-based test, PD Predict, receiving FDA Breakthrough Device Designation
How Hardian helped Envisionit gain FDA clearance
With Hardian Health’s support, Envisionit Deep AI® became the first ever African-founded company to receive FDA clearance for an AI device. In this article, we share Envisionit’s journey to 510(k) clearance.
Building a Go-To-Market Strategy with AlphaBiomics
We supported AlphaBiomics' co-founder and CEO, Anthony Williamson, to develop a go-to-market (GTM) strategy to help them bring precision medicine to chronic inflammatory diseases.
Spotlab’s software IVD CE marking story
Hardian worked closely with Miguel, co-founder of Spotlab and Adriana, Spotlab’s biomedical engineer and regulatory affairs manager to assist them with CE marking for their software IVD.
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.