Elekta's Advanced Linac Receives FDA Green Light, Reshaping U.S. Radiation Therapy Landscape

Elekta has recently secured FDA 510(k) clearance for its Evo CT-Linac system, marking a significant milestone in advanced radiation oncology. This next-generation linac platform is now available to treatment centers across the United States, promising to transform how radiation therapists visualize and target tumors with unprecedented precision. The regulatory approval represents more than a product launch—it signals Elekta’s commitment to advancing personalized cancer care through cutting-edge linear accelerator technology.

Game-Changing Linac Technology Combines Precision Imaging with AI Innovation

The Elekta Evo linac stands apart by integrating high-fidelity CT imaging directly into the treatment apparatus, allowing clinicians to obtain real-time visualization of tumors and vulnerable tissues during every therapy session. At the core of this advancement lies Iris, an AI-powered imaging system that fundamentally changes how radiation oncologists approach treatment planning.

Unlike traditional cone-beam CT imaging methods, the Iris imaging technology embedded in Elekta’s linac uses advanced AI algorithms to dramatically reduce image scatter and enhance reconstruction quality. This results in sharper, clearer images with significantly fewer artifacts, enabling healthcare providers to identify soft tissue structures with greater confidence. Clinical validation from partners at the Medical College of Wisconsin confirms that this enhanced visualization translates directly into more accurate patient positioning and superior treatment adaptation as anatomy changes during the therapy course.

The versatility of this linac system extends beyond new installations. Iris can be retrofitted onto existing Elekta linear accelerators, allowing treatment centers to upgrade their current equipment without complete system replacement. This approach lowers the barriers to adoption while simultaneously extending the operational lifespan of installed infrastructure—a strategic advantage for clinics managing capital constraints.

Market Momentum: Radiation Therapy Linac Market Expanding Rapidly

The global radiation therapy sector is experiencing robust growth momentum. Market research indicates the radiation therapy market was valued at $8.64 billion in 2026 and is projected to expand at a compound annual growth rate (CAGR) of 9% through 2035. This expansion is driven by multiple converging factors: rising cancer incidence worldwide, escalating healthcare provider demand for advanced treatment solutions, and continuous technological innovation in linac systems and imaging capabilities.

Elekta’s FDA clearance arrives at an opportune moment, positioning the company to capture significant share of this expanding market. By offering a linac platform that combines advanced imaging with artificial intelligence integration, Elekta addresses a critical clinical need—enabling radiation oncologists to deliver more personalized, precise treatments while improving operational workflow and patient outcomes.

Stock Performance Reflects Market Confidence

The market has responded positively to Elekta’s regulatory achievement. Since the FDA announcement, EKTAY shares advanced 3.7% in trading. Over the preceding six months, the stock appreciated 38.4%, substantially outpacing both the broader medical device industry’s 12.2% gain and the S&P 500’s 12.8% performance. This outperformance underscores investor recognition that Elekta’s linac innovation positions the company for sustained competitive advantage.

With a market capitalization of $2.51 billion, Elekta now holds strategic assets in radiation oncology that extend well beyond immediate hardware sales. The linac approval unlocks recurring revenue opportunities through software upgrades, AI algorithm enhancements, and comprehensive service contracts—creating multiple pathways to long-term profitability.

Strategic Transformation Accelerates Operational Excellence

Beyond the product milestone, Elekta is simultaneously implementing a comprehensive organizational restructuring. The company is decentralizing decision-making authority while streamlining operational processes to accelerate product development cycles and enhance commercial execution. Management projects this transformation will generate annual cost savings exceeding SEK 500 million, with full financial benefits materializing in the first quarter of fiscal 2026.

Additionally, Elekta completed a rigorous second-level review of its order backlog, resulting in the cancellation of SEK 2,197 million in orders based on stricter order validation criteria. While this appears counterintuitive, the action strengthens predictability and positions the company for sustainable profitability by eliminating low-quality orders and improving order quality.

Linac Innovation Fuels Long-Term Growth Narrative

The convergence of FDA regulatory approval, advanced linac technology, and favorable market dynamics creates a compelling growth thesis for Elekta. By positioning its next-generation linac system at the intersection of precision imaging, artificial intelligence, and operational flexibility, the company strengthens its competitive moat while expanding its addressable market in radiation oncology.

Clinical adoption of the Evo linac across U.S. treatment centers will likely drive incremental revenue growth, deepen customer relationships, and create substantial upgrade and service revenue streams. As personalized, AI-assisted cancer treatment becomes standard practice, Elekta’s linac innovations establish a durable foundation for sustainable global expansion.