We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Elekta Wins FDA Nod for Evo CT-Linac, Boosting U.S. Radiation Oncology
Read MoreHide Full Article
Key Takeaways
EKTAY's Evo CT-Linac won FDA 510(k) clearance, making the CT and linac system available across the U.S.
The clearance supports U.S. expansion, as AI-driven Iris imaging enables more precise radiation therapy.
Strong adoption and upgrade-ready Iris technology lowers clinic barriers and extends system life.
Elekta (EKTAY - Free Report) recently announced that its Elekta Evo CT-Linac has received 510(k) clearance from the FDA, making the system available to radiation oncology professionals across the United States. Evo integrates high-quality CT imaging directly with linear accelerator functionality, allowing clinicians to visualize tumors and organs-at-risk with greater clarity during every treatment.
Per management, FDA clearance marks a critical step in Elekta’s strategy to expand its footprint in the United States. Elekta Evo CT-Linac positions the company to support more personalized and precise radiation therapy while improving operational efficiency for clinics of varying sizes. EKTAY emphasized that Evo’s versatility and AI-driven imaging capabilities enable providers to adopt advanced imaging and raise the level of cancer treatment in the United States.
EKTAY Stock’s Trend Following the News
Shares of Ektay gained 3.7% since the announcement on Friday. Over the past six months, the stock has risen 38.4% compared with the industry’s 12.2% growth and the S&P 500’s 12.8% gain.
In the long run, FDA approval paves the way for Evo CT-Linac’s United States commercialization and expands Elekta’s addressable market in radiation oncology. By offering a balance of advanced imaging, AI integration and upgrade flexibility, the company strengthens its credibility and competitive positioning against peers. Increased adoption in clinics can drive revenue growth, deepen customer relationships and support recurring upgrade and service opportunities. By offering advanced, personalized cancer care technology that improves clinical outcomes and efficiency, Elekta builds a solid foundation for sustainable growth worldwide.
EKTAY currently has a market capitalization of $2.51 billion.
Image Source: Zacks Investment Research
More on the Evo CT-Linac Clearance
During radiation therapy, doctors need clear, high-quality images to locate tumors and protect nearby healthy organs. Evo meets this need with Iris, a high-definition, AI-enhanced imaging capability, which helps clinicians find targeted areas for treatment and sensitive structures more clearly during each session. Elekta Evo is gaining strong adoption, with more clinics using the system and setting higher standards for radiation therapy through its advanced treatment features across Europe and other regions.
In contrast to traditional cone-beam CT imaging, Iris uses AI algorithms to minimize scatter and improve image reconstruction, which results in clearer images and more accurate visualization of anatomical structures, helping clinicians make better treatment decisions. Iris is designed to be easily added as an upgrade to existing Elekta linear accelerators, lowering barriers to adoption and extending the useful life of installed systems.
Clinical feedback from Eenas Omari, PhD, at the Medical College of Wisconsin, one of the development partners of Iris, underscores the system’s potential to deliver better image quality, resulting in clearer visualization of soft tissue and fewer artifacts. This enhanced image quality supports accurate daily patient positioning and allows clinicians to adapt treatment plans with greater confidence as anatomical changes occur over the course of therapy.
Industry Prospects Favoring the Market
Going by data provided by Precedence Research, the radiation therapy market is valued at $8.64 billion in 2026 and is expected to witness a CAGR of 9% through 2035. Factors like the increasing number of patients with cancer and increased demand from the medical sector, with the increasing number of new technologies, are driving the growth of the radiation therapy market.
Other News
Elekta has started implementing a new operating model designed to speed up product development, strengthen commercial performance and improve overall operational efficiency, enabling better service for customers and patients. As part of this transformation, the decision-making authority will be decentralized. This streamlined structure is expected to generate annual cost savings of at least SEK 500 million, with the full financial impact taking effect from the first quarter of fiscal 2026.
In addition, a second-level review of orders has been completed, leading to the cancellation of SEK 2,197 million in orders. This action is based on a stricter interpretation of order criteria and is intended to improve predictability and support long-term profitability.
AtriCure, currently flaunting a Zacks Rank #1 (Strong Buy), reported a third-quarter 2025 adjusted loss per share of 1 cent, 90.9% narrower than the Zacks Consensus Estimate. Revenues of $134.3 million beat the Zacks Consensus Estimate by 2.1%. You can see the complete list of today’s Zacks #1 Rank stocks here.
ATRC has an estimated earnings growth rate of 64.2% for 2025 compared with the industry’s 12.9% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 67.1%.
Veracyte, sporting a Zacks Rank #1 at present, reported third-quarter 2025 adjusted earnings per share (EPS) of 51 cents, which surpassed the Zacks Consensus Estimate by 59.4%. Revenues of $131.8 million beat the Zacks Consensus Estimate by 5.5%.
VCYT has an estimated earnings growth rate of 39.5% for 2025 compared with the industry’s 14.8% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 45.12%.
Intuitive Surgical, carrying a Zacks Rank #2 (Buy) at present, reported third-quarter 2025 adjusted earnings per share (EPS) of $2.40, which surpassed the Zacks Consensus Estimate by 20.6%. Revenues of $2.51 billion beat the Zacks Consensus Estimate by 3.9%.
ISRG has an estimated long-term earnings growth rate of 15.7% compared with the industry’s 12.6% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 16.3%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Elekta Wins FDA Nod for Evo CT-Linac, Boosting U.S. Radiation Oncology
Key Takeaways
Elekta (EKTAY - Free Report) recently announced that its Elekta Evo CT-Linac has received 510(k) clearance from the FDA, making the system available to radiation oncology professionals across the United States. Evo integrates high-quality CT imaging directly with linear accelerator functionality, allowing clinicians to visualize tumors and organs-at-risk with greater clarity during every treatment.
Per management, FDA clearance marks a critical step in Elekta’s strategy to expand its footprint in the United States. Elekta Evo CT-Linac positions the company to support more personalized and precise radiation therapy while improving operational efficiency for clinics of varying sizes. EKTAY emphasized that Evo’s versatility and AI-driven imaging capabilities enable providers to adopt advanced imaging and raise the level of cancer treatment in the United States.
EKTAY Stock’s Trend Following the News
Shares of Ektay gained 3.7% since the announcement on Friday. Over the past six months, the stock has risen 38.4% compared with the industry’s 12.2% growth and the S&P 500’s 12.8% gain.
In the long run, FDA approval paves the way for Evo CT-Linac’s United States commercialization and expands Elekta’s addressable market in radiation oncology. By offering a balance of advanced imaging, AI integration and upgrade flexibility, the company strengthens its credibility and competitive positioning against peers. Increased adoption in clinics can drive revenue growth, deepen customer relationships and support recurring upgrade and service opportunities. By offering advanced, personalized cancer care technology that improves clinical outcomes and efficiency, Elekta builds a solid foundation for sustainable growth worldwide.
EKTAY currently has a market capitalization of $2.51 billion.
Image Source: Zacks Investment Research
More on the Evo CT-Linac Clearance
During radiation therapy, doctors need clear, high-quality images to locate tumors and protect nearby healthy organs. Evo meets this need with Iris, a high-definition, AI-enhanced imaging capability, which helps clinicians find targeted areas for treatment and sensitive structures more clearly during each session. Elekta Evo is gaining strong adoption, with more clinics using the system and setting higher standards for radiation therapy through its advanced treatment features across Europe and other regions.
In contrast to traditional cone-beam CT imaging, Iris uses AI algorithms to minimize scatter and improve image reconstruction, which results in clearer images and more accurate visualization of anatomical structures, helping clinicians make better treatment decisions. Iris is designed to be easily added as an upgrade to existing Elekta linear accelerators, lowering barriers to adoption and extending the useful life of installed systems.
Clinical feedback from Eenas Omari, PhD, at the Medical College of Wisconsin, one of the development partners of Iris, underscores the system’s potential to deliver better image quality, resulting in clearer visualization of soft tissue and fewer artifacts. This enhanced image quality supports accurate daily patient positioning and allows clinicians to adapt treatment plans with greater confidence as anatomical changes occur over the course of therapy.
Industry Prospects Favoring the Market
Going by data provided by Precedence Research, the radiation therapy market is valued at $8.64 billion in 2026 and is expected to witness a CAGR of 9% through 2035. Factors like the increasing number of patients with cancer and increased demand from the medical sector, with the increasing number of new technologies, are driving the growth of the radiation therapy market.
Other News
Elekta has started implementing a new operating model designed to speed up product development, strengthen commercial performance and improve overall operational efficiency, enabling better service for customers and patients. As part of this transformation, the decision-making authority will be decentralized. This streamlined structure is expected to generate annual cost savings of at least SEK 500 million, with the full financial impact taking effect from the first quarter of fiscal 2026.
In addition, a second-level review of orders has been completed, leading to the cancellation of SEK 2,197 million in orders. This action is based on a stricter interpretation of order criteria and is intended to improve predictability and support long-term profitability.
Elekta AB Price
Elekta AB price | Elekta AB Quote
EKTAY’s Zacks Rank & Key Picks
Currently, EKTAY carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are AtriCure (ATRC - Free Report) , Veracyte (VCYT - Free Report) and Intuitive Surgical (ISRG - Free Report) .
AtriCure, currently flaunting a Zacks Rank #1 (Strong Buy), reported a third-quarter 2025 adjusted loss per share of 1 cent, 90.9% narrower than the Zacks Consensus Estimate. Revenues of $134.3 million beat the Zacks Consensus Estimate by 2.1%. You can see the complete list of today’s Zacks #1 Rank stocks here.
ATRC has an estimated earnings growth rate of 64.2% for 2025 compared with the industry’s 12.9% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 67.1%.
Veracyte, sporting a Zacks Rank #1 at present, reported third-quarter 2025 adjusted earnings per share (EPS) of 51 cents, which surpassed the Zacks Consensus Estimate by 59.4%. Revenues of $131.8 million beat the Zacks Consensus Estimate by 5.5%.
VCYT has an estimated earnings growth rate of 39.5% for 2025 compared with the industry’s 14.8% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 45.12%.
Intuitive Surgical, carrying a Zacks Rank #2 (Buy) at present, reported third-quarter 2025 adjusted earnings per share (EPS) of $2.40, which surpassed the Zacks Consensus Estimate by 20.6%. Revenues of $2.51 billion beat the Zacks Consensus Estimate by 3.9%.
ISRG has an estimated long-term earnings growth rate of 15.7% compared with the industry’s 12.6% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 16.3%.