A Brief Overview of Q4 2024

2024 was a year of dynamic change and remarkable achievements at Graylight Imaging. We successfully onboarded new business partners and delivered cutting-edge AI medical projects. Our R&D team continued to innovate, presenting their work at prestigious conferences like MICCAI and ESCC. We also restructured our organization, setting the stage for even greater achievements. Despite the busy year, we made time for team-building activities to foster a strong company culture. As we close this chapter, we're excited about the opportunities that lie ahead.

Graylight Innovations completes acquisition of Graylight Imaging

At the beginning of September 2024, Graylight Innovations acquired a majority stake in our company. Thanks to this venture, we can devote even more effort to research and development to improve cardiac diagnostic methods based on heart CT scans.

The new owners of our company are:

• Aniela Hejnowska , an expert in managing organizations in the e-commerce, health, and new technology sectors;
• Professor Maciej Banach , a world-recognized cardiologist, top cited scientist, President of the International Lipid Expert Panel, and academic lecturer at the Medical University of Lodz and Johns Hopkins University in Baltimore;
• Dr. Eng. Jaros?aw Bu?ka , PhD, an expert in AI, digital transformation, and telemedicine;
• Szymon Janota , former and current CEOs of Graylight Imaging;
• Ewa Kieczka -Baranowska, the former Head of Business and People.

The knowledge and experience of the ownership team, combined with the existing team of experts in computer science, medicine, and physics, create a unique environment for the development of innovative solutions in the healthcare sector, with a particular focus on cardiology.??

ISO 13485:2016 at GLI – Summary of 2024

In 2024, we conducted 8 internal audits to assess QMS compliance within individual teams. These audits focused on ISO 13485:2016, EN 62304:2006/A1:2015, and ISO 14791:2019 standards, with results demonstrating effective implementation and process adherence at GLI.

Our declarations regarding ISO compliance in medical software development require independent verification. Otherwise, they could be dismissed as mere boasts. With this in mind, we undergo an annual audit conducted by the notified body?TüV NORD, whose task is to assess whether processes implemented at GLI comply with the requirements of ISO 13485:2016.?

However, the 2024 audit was special. For the first time, we had the opportunity to host an external observer from the?Polish Center for Accreditation, whose task was to assess the work of the auditors. It was a valuable experience for us to see what such an “audit during an audit” looks like.

A new year brings new goals and challenges

1. Get ready for an exciting year ahead! In 2025, we'll be involved deeper into our product development. Our highly anticipated product launch is on the horizon, and we can't wait to share more details with you soon. Stay tuned for exclusive insights into the features and benefits that will set our product apart.
2. R&D activities will continue to be a significant part of our work. Development and research are firmly embedded in our company's DNA, so scientific activities and publications will be a constant presence in the coming months.
3. While we're busy developing new products, we haven't forgotten about our valued customers. We're committed to providing tailored solutions that meet their unique needs. Keep an eye out for case studies showcasing how our products have helped businesses like yours achieve success.
4. In addition to our product launch, we're also expanding our team! We have several new job openings available. If you're passionate about medical imaging or software development and want to be part of an innovative company, check out our careers page.

As you can see, we are entering this year with renewed energy and fresh ideas, ready to face new business challenges. And this is what we wish for all of you as well.