Artificial intelligence-based medical technology company, Median Technologies (EPA: ALMDT), is well on track for a formal submission to the US FDA in May.
Median announced the successful conclusion of its studies for its AI/ML-based computer-aided detection and diagnosis (CADe/CADx) software, eyonis Lung Cancer Screening (LCS).
Furthermore, the company has met a key requirement for regulatory submissions in the US and Europe. The company will file for US FDA clearance first, followed by a CE marking submission in Europe in June.
Based on standard review timelines, Median expects to receive FDA 510(k) clearance in Q3 2025 and CE marking in Q1 2026.
Median developed the eyonis LCS SaMD to enable early detection and characterization of lung nodules, classifying them as “probably benign,” “suspicious,” or “very suspicious” to aid cancer diagnosis and guide patient management.
The software helps radiologists detect, locate, characterize, and assess pulmonary nodules in medical images by generating a proprietary report that highlights and scores each nodule. Additionally, eyonis LCS supports the early identification of tumours. The means improving patient care while reducing unnecessary tests, procedures, and healthcare costs.
Final results from the RELIVE study confirm that Median’s eyonis LCS SaMD met all key endpoints. Consequently, this demonstrates statistically significant performance superior to the state of the art, along with proven device safety and efficacy. These results support the intended use of eyonis LCS, which Median shared with the EU Notified Body and discussed with the FDA during the Q submission phase. Regulatory bodies in the US and Europe require device efficiency and safety to match its intended use for marketing authorization.
Read more: Breath Diagnostics onboards new president and closes critical financing
Read more: Breath Diagnostics pioneers novel lung cancer breath test
AI will help with early cancer detection
Median Technologies plans to present pivotal study results at upcoming medical and scientific conferences. It will also submit scientific papers to peer reviewed publications in the coming quarters.
Early detection makes lung cancer highly treatable. AI-based Software as a Medical Device (SaMD) will help scale lung cancer screening programs worldwide. Median Technologies also developed eyonis LCS, an AI powered SaMD, to expand Low Dose CT lung cancer screening programs in the United States, Europe, and beyond. This technology aims to save lives, help medical professionals conduct more screenings, and reduce healthcare costs.
While Median Technologies is advancing AI powered lung cancer screening, other companies are also innovating early cancer detection. These efforts highlight the growing role of technology in improving patient outcomes.
Exact Sciences Corp. (NASDAQ: EXAS) is a leader in early cancer detection, specializing in molecular diagnostics. The company developed Cologuard, a non-invasive, DNA-based screening test for colorectal cancer.
Using advanced stool DNA analysis and biomarker technology, Cologuard detects precancerous and cancerous cells, allowing for earlier intervention. Exact Sciences is also expanding its portfolio with liquid biopsy tests. These tests analyze blood samples for multiple cancer types, further supporting early detection efforts.
Breath Diagnostics Inc., a Kentucky-based company, is pioneering a novel approach to lung cancer screening.
Its proprietary OneBreath technology analyzes volatile organic compounds (VOCs) in exhaled breath to detect lung cancer at an early stage.
Furthermore, this non invasive method provides a simple and cost effective alternative to traditional imaging techniques, making screening more accessible. By identifying metabolic changes linked to cancer, OneBreath offers a promising advancement in early diagnosis.
.
