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- Elekta's Evo CT-Linac system received FDA 510(k) clearance, enabling U.S. radiation oncology professionals to access integrated high-quality CT imaging with linear accelerator functionality. - The system features Iris, an AI-enhanced imaging capability that provides clearer visualization of tumors and organs-at-risk compared to traditional cone-beam CT imaging. - FDA approval positions Elekta to expand its U.S. market presence in the $8.64 billion radiation therapy market, which is expected to grow at 9% CAGR through 2035.
- RefleXion Medical's SCINTIX biology-guided radiotherapy platform demonstrated 100% local disease control in patients with lung and bone metastases during the nine-month follow-up period of the PREMIER trial. - The study showed that 41% of patients achieved complete or partial responses, with 47% of bone metastases patients and 35% of lung tumor patients obtaining these favorable outcomes. - SCINTIX represents the first precision radiotherapy system to combine PET imaging with a linear accelerator, enabling real-time biology-guided radiation delivery while maintaining excellent safety profiles. - The platform received FDA approval in 2023 and has secured Medicare reimbursement coverage, positioning it as a potential first-in-class treatment option for both localized and metastatic disease.
- Preliminary results from the ERECT trial demonstrate that Elekta Unity MR-Linac significantly reduces erectile dysfunction rates in prostate cancer patients compared to conventional radiotherapy. - The MR-guided radiotherapy system enables precise visualization of critical structures, allowing physicians to deliver therapeutic doses to the prostate while minimizing radiation exposure to erectile tissues. - At 18 months post-treatment, only 16% of patients treated with neurovascular-sparing MR-guided radiotherapy experienced erectile dysfunction, compared to 36% in the control group.