CergenX

CergenX is proud to announce that we have achieved ISO 13485:2016 certification for our Quality Management System. Gaining ISO 13485:2016 certification at this early stage of our development ensures that the highest quality standards are integrated across our product development, production, and post-market processes. This milestone positions CergenX to deliver excellence in safety and quality as we scale. The journey to certification involved a steep learning curve, support from external regulatory experts, and a strong commitment from the entire team. Special thanks to Bernard Kelleher, Finola B., Paul Doherty and Sean Griffin for their dedication and hard work in reaching this goal. Achieving this certification is not just a requirement—it sets the benchmark for quality management in the medical device industry, reinforcing our commitment to delivering safe, high-quality products globally. #MedTechInnovation #HealthcareInnovation #AiForGood

It's #WorldCerebralPalsyDay 💚 ⁉ Did you know, an estimated 150 babies receive a Cerebral Palsy(CP) diagnosis in Ireland each year, and an estimated 3,000 children and young people and 9,500 adults are living with CP in Ireland? It is in fact the most common lifelong physical disability in Ireland. Earlier this year, we launched a new ground-breaking five-year research programme called ELEVATE - led by INFANT at University College Cork, partnered with Royal College of Surgeons in Ireland (RCSI) University of Medicine and Health Sciences and Trinity College Dublin, as well as the tertiary-level maternity hospitals. ELEVATE is co-funded by Research Ireland (formerly SFI) and the Cerebral Palsy Foundation (CPF), and aims to improve the prevention, detection and treatment of early brain injury and cerebral palsy in Ireland. By fostering collaboration between clinical, academic, and industry partners, as well as involving individuals with CP and their families from the outset, Ireland is set to become a global leader in CP research and care. Ultimately this programme aims to provide hope and better outcomes for children and families impacted by CP. Read more about #ELEVATE here: https://lnkd.in/egPrWiK4

Yesterday, we attended MedTech Advance: Transforming Clinical Investigations in Ireland, organised by the HRB National Clinical Trials Office (NCTO) and hosted at Medtronic’s Customer Innovation Centre in Galway. A few thoughts and takeaways: 💡 We explored Ireland’s clinical trial landscape in numbers, discussing the practical steps, timelines, and common gaps that can ease future applications. Dr Emer Sherry, Irish Medtech’s Senior Public Policy & Regulatory Affairs Executive, set the tone for the day in her opening address by highlighting the importance of high-level stakeholder relationships, influencing policy, and linking clinical research to market—demonstrating how these combined elements can drive impactful clinical research in Ireland and build strong relationships between regulators and trial sponsors. The message was clear from all involved, “We’re here to help”—supporting, facilitating, and guiding while maintaining the highest standards of safety, quality, and rigour. 💡 Trial sponsors from all sizes of industry, including Marianne Wanten (Medtronic), Annette Kent (FIRE1 ), and Dr Anne-Marie Byrne (Royal College of Surgeons in Ireland (RCSI)), shared real-world insights on setting up an impressive range of trials, both in Ireland and internationally. The consensus? While trial activation in Ireland can be slower and more admin-heavy than other regions, the quality of trials here is outstanding—high enrolment, quality data, strong communication, and excellent research infrastructure. 💡 Prof. John Kilmartin, Adjunct Professor at the Institute for Clinical Trials (University of Galway) & Independent MedTech Regulatory Advisor, shared valuable insights into the regulatory landscape, shedding light on both the challenges and the significant opportunities within Ireland’s MedTech sector. 💡A poignant moment came from patient Michael Mee, whose story of how a clinical trial gave him his life back was a powerful reminder of the real-world impact of this work. 💡 Finally, the event underscored why Galway is rightfully one of Europe’s premier MedTech hubs. The open and collaborative approach we witnessed—between academia, industry, healthcare professionals, and patients—drives its success. With eight of the world’s top ten MedTech companies having a presence in Galway, it's clear that the city remains central to global innovation in this space. Thank you to NCTO and Medtronic for this excellent event, showing that strengthening the connection between Ireland’s clinical trial investigators, sponsors, and medtech developers holds enormous potential for life-changing benefits. #MedTechInnovation #MedTechAdvance2024 #HealthcareInnovation Ibec Health Research Board (HRB) Health Products Regulatory Authority (HPRA)

This week, Oscar Gleeson visited the Enterprise Ireland offices in Boston. Huge thanks to Jennie Lynch and her team for a productive meeting (and for sharing that incredible office view!). Always great to connect with the EI team and continue expanding CergenX's reach in the US. #MedTechInnovation #HealthcareInnovation #AiForGood

The buzz around MedTech and Healthcare innovation eclipsed everything else at DisrupTech 2024. It’s such an exciting time for this industry in Ireland, with a vibrant display of new ideas reflecting the strong role and support of the Disruptive Technology Innovation Fund. Held at the Printworks, Dublin Castle, and hosted by DTIF, the event featured compelling panel discussions on both government and private funding. We heard from industry leaders, including: - Brian Shields , Co-founder & CEO of Neurent Medical Limited - Jenny Fitzgerald, Chief Experience Officer at Deciphex Limited - Fionn Lahart, Co-founder & CEO of LUMA Vision Limited Marina Niforos, European Innovation Council (EIC) Jury Member, shared invaluable insights into the EIC funding process, while Thom Rasche from Earlybird Venture Capital and Elaine C. from Atlantic Bridge offered their perspectives on what VCs look for in investment opportunities. Our CEO, Jason Mowles, took the opportunity to network with potential investors as we prepare for the next CergenX funding round. Special thanks to Minister Peter Burke for his opening remarks and to Minister Paschal Donohoe for his video message. It was a super day all round. We were delighted to hear the Department of Enterprise, Trade and Employment’s call to "Think Bigger"—a great motivator for Irish start-ups to aim high! #DisruptTech #MedTechInnovation #AIforGood  #DisrupTech2024

Great to see INFANT Research Centre being recognised in the Examiner! As a proud spin-out, CergenX is excited to see their groundbreaking work being highlighted. Congrats to Prof Geraldine Boylan and the entire team. #neonatology #healthcareinnovation

Team is everything! 💜 INFANT, UCC prides itself in having a multidisciplinary powerhouse, with over 100+ staff members and growing from healthcare practitioners, research scientists, engineers, and support staff. These moments of connection are key to getting to know new colleagues and building and fostering collaborative working relationships. We, as a team are working towards a shared mission, to be at the international forefront of innovative and impactful research in maternal and child health and these touch points are key. Thanks to our project partners CergenX for fueling our lunchtime networking!  🍕

We had the pleasure of attending the Enterprise Ireland USA Healthcare Seminar on Wednesday, held at the Enterprise Ireland HQ in Dublin. A huge thank you to Jennie Lynch for organising such a well-curated event and for the warm welcome. Bringing together this group of professionals with key executives from leading US healthcare systems made for an exceptionally worthwhile day. Looking forward to applying the insights gained and continuing the conversations sparked during the seminar.

We're thrilled to welcome Oscar Gleeson to the CergenX team as our Business Development and Commercialisation Manager! Oscar brings a wealth of knowledge and experience, having recently completed the University of Notre Dame ESTEEM Graduate Program—a prestigious Master of Science degree. During his time in the program, Oscar collaborated with CergenX on his capstone project, already demonstrating his talent for driving commercialisation efforts. Based in Boston, Oscar marks a milestone as our first US employee! 🇺🇸 We’re excited to have him on board and look forward to the contributions he will make as we continue to grow. Welcome, Oscar! #medtechinnovation #healthcareinnovation #braininjury #irishtechstartup

Team meetings with a view! ☀️ A beautiful day in Kinsale for a productive session with some of the CergenX team. Exciting developments are in progress, and we look forward to sharing more in the coming months... #MedTechInnovation #AiForGood #StartUpLife