Navigating the new frontier: How regulatory leadership in AI development and commercialization can accelerate precision medicine

Executive Summary

 

In the complex and rapidly evolving landscape of AI-driven healthcare, regulatory expertise is a strategic asset. The combined, proven experience of Tempus and Paige in navigating global regulatory pathways de-risks development, builds clinical trust, and accelerates the delivery of trustworthy innovative diagnostic and therapeutic tools to clinicians, researchers, and patients.

Why regulatory leadership is non-negotiable in the AI era

 

Artificial intelligence (AI) and multimodal data are revolutionizing healthcare, offering the potential to deliver precision medicine at an unprecedented scale. From identifying novel biomarkers based on routinely stained pathology slides to predicting therapy response from genomic data, these technologies promise to make patient care more personalized, proactive, and effective.

 

However, translating a powerful algorithm from a research environment into a trusted clinical tool is a formidable challenge. It requires more than just innovative science; it demands robust validation and a deep and proactive understanding of a complex global regulatory landscape. At Tempus, we believe that regulatory leadership is a core competency, essential for realizing the full promise of AI in medicine. Together with Paige, a Tempus company, we have built an unrivaled track record of regulatory success that serves as the foundation for our partners and the broader healthcare ecosystem.

 

Charting the new territory of AI regulation

 

Bringing AI-powered software as a medical device (SaMD) to market involves navigating a framework that has unique challenges.

 

It's essential to provide robust evidence of analytical and clinical validity, demonstrating that an AI model performs accurately, reliably, and consistently across diverse patient populations and clinical settings. Additionally, a robust Quality Management System must be aligned with international standards such as ISO 13485 (Medical Devices) and ISO 27001 (Information Security), helping ensure AI applications meet stringent regulatory, privacy, and security requirements. It's also necessary to expertly navigate evolving frameworks, such as the EU’s comprehensive In Vitro Diagnostic Regulation (IVDR). Understanding and mastering these pathways—from Breakthrough Device Designation to 510(k) clearance and De Novo classification—is critical.

 

A legacy of regulatory firsts

 

Tempus and Paige have not just participated in this evolving regulatory environment; we have actively shaped it through a series of landmark achievements. Our combined portfolio of regulatory authorizations is a testament to our strategic, evidence-based approach.

 

From AI-powered pathology to companion diagnostics, we provide end-to-end expertise to navigate complex regulatory submissions:

Paige has achieved multiple historic regulatory milestones that have paved the way for the AI driven pathology industry. This journey of innovation includes securing the first and only FDA De Novo marketing authorization for an AI-based pathology product with Paige Prostate Detect, a true precedent-setting achievement. The FDA granted Breakthrough Device Designations to Paige Breast Lymph Node and Paige PanCancer Detect, enabling more collaborative Agency review for tools that can for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This leadership extends globally, with CE marking to IVDR requirements for Paige Prostate, making this powerful digital pathology solution available to clinicians and laboratories across Europe and the United Kingdom.

 

In addition to the regulatory legacy that Paige has, Tempus has also developed a robust portfolio of regulated products that integrate our Multi-omics platform with sophisticated AI to support clinical decision-making. Our xT CDx assay is a 648-gene tissue-based NGS-based test for molecular profiling of all solid malignant tumors, that also includes companion diagnostic (CDx) claims for colorectal cancer (CRC) patients. We have also secured multiple FDA 510(k) clearances for AI algorithms in cardiology, including ECG-AF for atrial fibrillation risk detection in certain patients, as well as for our xR IVD RNA-sequencing assay. Our regulatory expertise extends worldwide, with 10 CE-marked assays in the European Union, demonstrating our capability to meet international standards.

 

Beyond the approval: Turning regulatory expertise into strategic value

 

For our partners in biopharma and for the health systems we serve, our regulatory expertise translates directly into tangible value that accelerates the entire development lifecycle.

 

• Accelerate Innovation and De-risk Development: By integrating regulatory strategy into the earliest stages of product development, and leveraging our large repository of diverse data, we design studies and build evidence to meet health authority requirements efficiently. This proactive approach minimizes delays, reduces the risk of late-stage failures, helps demonstrate generalizability and accelerates the path from concept to clinic. For our biopharma partners, this provides a clear and proven pathway for developing and launching companion diagnostics.

 

• Build Clinical Trust and Drive Adoption: In a field where new technology can be met with healthy skepticism, these regulatory milestones may provide clinicians with the confidence to integrate new AI tools into their workflows and to help them make critical patient care decisions. This trust is the cornerstone of clinical adoption and the bridge between a novel tool and real-world patient impact.

 

• Enable Strategic Partnerships: Our regulatory and commercialization expertise is a key reason why Tempus is a must-have partner in AI-driven drug development. We offer an end-to-end solution, from model development and clinical validation to a proven ability to achieve regulatory authorization and deploy solutions at scale through our extensive clinical network.

 

Partnering for the future: From code to clinical impact

 

In the pursuit of precision medicine, innovation and regulation are two sides of the same coin, one cannot succeed without the other. The combined expertise of Tempus and Paige represents a unique and powerful capability in the healthcare industry—the proven ability to develop cutting-edge AI and multimodal applications and navigate them successfully through the most stringent regulatory channels in the world.

 

Our commitment to regulatory excellence ensures that the tools we build are not only powerful but also safe, reliable, and worthy of the trust that patients and providers place in them. This leadership de-risks the journey for our partners and clears the path for a future where data-driven insights improve the life of every patient.

 

Explore how our regulatory expertise can advance your drug development goals.

 

Contact us to learn more.

 

References

 

1. Tempus. (2022). Tempus CE Marks Its Broad-Panel Genomic Sequencing and Algorithmic Diagnostic Tests
2. Tempus. (2023). Tempus Receives U.S. FDA Approval for xT CDx, a NGS-Based In Vitro Diagnostic Device
3. Tempus. (2025). Tempus Receives U.S. FDA 510(k) Clearance for Tempus xR IVD, its RNA NGS In Vitro Diagnostic Device
4. Tempus. (2024). Tempus Receives U.S. FDA 510(k) Clearance for Tempus ECG-AF, an AI-based Algorithm that Identifies Patients at Increased Risk of AFib
5. Tempus. (2025). Tempus Receives U.S. FDA 510(k) Clearance for Tempus ECG-Low EF Software
6. Tempus. (2025). Tempus Receives U.S. FDA Special 510(k) Clearance for Updated Tempus Pixel Device
7. Tempus Pixel is US FDA cleared (K203744) for Cardio, Lung and Oncology applications. Also hosts 3rd party FDA cleared solutions from Infervision (K192880), iCAD (K203822), Therapixel (K211541), Quibim (K242683), Imvaria (K241891) and DeepLook (K202084).
8. Tempus Pixel is FDA-cleared (K203744) and CE Marked. Lesion detection and risk classification for clinically significant prostate cancer is powered by Quibim's QP-Prostate® CAD which is FDA-cleared (K242683) and CE Marked. Arterys Inc is the manufacturer of Tempus Pixel. Quibim is the manufacturer QP-Prostate® CAD.
9. Tempus Pixel is FDA-cleared (K203744) and CE Marked. Prostate gland segmentation is powered by Quibim’s QP-Prostate® (K203582). QC against PI-RADS v2.1 guidelines is powered by Quibim’s QP-Prostate® (K203582) and QP-Prostate® CAD (K242683). Lesion detection and risk classification for clinically significant prostate cancer is powered by Quibim's QP-Prostate® CAD (K242683). Arterys Inc is the manufacturer of Tempus Pixel. Quibim is the manufacturer of QP-Prostate® and QP-Prostate® CAD.
10. CE-IVDR for use with whole slide images visualized with the Paige FullFocus Image Viewer and digitized with Philips Ultra Fast Scanner, Leica Aperio AT2 Scanner, Leica GT450 Scanner, or Hamamatsu S360 Scanner. In the US, Paige Prostate Detect is FDA-authorized for clinical use.
11. Paige. (2023). U.S. FDA Grants Paige Breakthrough Device Designation for Cancer Detection in Breast Lymph Nodes
12. Paige. (2025). U.S. FDA Grants Paige Breakthrough Device Designation for AI Application that Detects Cancer Across Different Anatomic Sites
13. In the United States, FullFocus® is cleared for clinical use with Philips Ultrafast Scanner, Leica Aperio GT 450 DX, and Hamamatsu NanoZoomer S360MD Slide scanner system. Software intended for viewing and management of digital images of scanned surgical pathology slides as an aid to the pathologist to review and interpret these digital images. FullFocus is FDA cleared (K241273 and K201005) and CE Marked (Class A, EU IVDR).
14. U.S. Food and Drug Administration. (2021). Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan.
15. European Union. (2017). Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
16. Paige. (2021). Paige Receives First Ever FDA Approval for an AI Product in Digital Pathology. Press Release.