Nova Leah, the Dundalk headquartered medical device security company which recently announced 78 jobs, has announced a significant global customer win.
Fresenius Medical Care, the world's largest provider of dialysis products and services, which reported revenues of US$ 17.9 billion in 2016, has selected and will implement Nova Leah’s cybersecurity risk management tool SelectEvidence, the world’s first expert cybersecurity risk management system for connected medical devices.
Fresenius Medical Care, which employs over 100,000 people worldwide and is quoted in Frankfurt and New York, cares for more than 300,000 patients in its global network of over 3,600 dialysis clinics. It also operates over 30 production sites worldwide to provide products such as dialysis machines and dialyzers.
Nova Leah, which has opened an office in Boston, is initially targeting customers in the imaging and electro medical device sectors in the US, a market that is estimated to be worth $155 billion of which connected devices account for approximately $51 billion.
SelectEvidence is designed to guide medical device manufacturers implementing cybersecurity requirements and best practices over the lifetime of devices in compliance with US FDA (Food & Drug Administration) recommendations during premarket and post market activities.