A spinout company from the Irish software research centre Lero, has developed a new cybersecurity risk management software application for North American medical device manufacturers.
Cyber Concept
Nova Leah developed its new cloud based product, SelectEvidence, to help medical device manufacturers implement cybersecurity requirements and best practices to comply with FDA recommendations for information security threats.
The product was developed by Lero researcher Anita Finnegan following a five-year R&D programme.
Nova Leah is backed by Irish Government agency Enterprise Ireland and has recently opened an office in Boston to serve the North American market. The startup’s initial investors include venture capital company COSIMO Venture Partners and Enterprise Ireland
Nova Leah CEO, Anita Finnegan said: “The recent WannaCry ransomware attack on the UK’s NHS highlights the importance of cybersecurity in the health sector. Today’s medical devices incorporate high levels of software and are connected across networks, online or wirelessly. As a result, medical device manufacturers are facing two major challenges: ensuring compliance with stricter regulatory measures and minimising the probability of malicious breaches aimed at medical devices and healthcare IT networks.”
Rob Frasca of COSIMO Venture Partners said: “We believe that cybersecurity for medical devices will be a significant new market. A first of its kind, we are not aware of any other company worldwide that can provide medical device manufacturers with an automated solution to implement and maintain cybersecurity requirements across medical device product portfolios.”
Nova Leah states that data breaches in the US are estimated to cost healthcare providers $5.6 billion annually. The startup is targeting customers in the imaging and electro medical device sectors in the US, a market estimated at $155 billion.
Dr. Joe Healy, divisional manager, High Potential Start Up Division, Enterprise Ireland, added, “Enterprise Ireland’s mission is to partner with innovative Irish businesses and entrepreneurs with the drive and ambition to scale globally. We look forward to working with Nova Leah to continue to support their growth ambitions.”