FDA clears Median Technologies’ lung nodule evaluation software

The US Food and Drug Administration (FDA) has cleared a lung crab detection instrumentality connected Median Technologies’ eyonis, a suite of artificial quality (AI)-based bundle for aboriginal crab diagnosis.

The French medtech company’s eyonis lung crab screening (LCS) is simply a computer-aided detection and diagnosis (CADe/CADx) Software arsenic a Medical Device (SaMD) that is designed to analyse imaging information generated from CT scans to assistance radiologists successful detecting and characterising parenchymal pulmonary nodules connected the lungs.

Following the announcement of the FDA support earlier banal markets opened connected 9 February, Median’s Paris-listed banal climbed by 19% to €5.10 ($6.06) astatine marketplace unfastened versus a erstwhile adjacent of €4.28. By 15:00 CET, the company’s banal had risen by astir 50%. Median Technologies has a marketplace headdress of €156m.

FDA clearance for eyonis LCS was supported by information from Median’s RELIVE (NCT06751576) pivotal trial, which met its superior endpoint, demonstrating that erstwhile utilized alongside a radiologist, the diagnostic achieved a statistically important betterment of p=0.027 implicit a radiologist alone.

Meanwhile, according to Median, successful shaper show investigating for a lung crab screening notation population, eyonis LCS demonstrated 93.3% sensitivity, 92.4% specificity, and a 99.9% Negative Predictive Value (NPV).

Median Technologies’ CEO and recovered Fredrik Brag commented: “We judge eyonis LCS volition beryllium to beryllium a gamechanger for objective teams arsenic they negociate rising screening volumes and assistance healthcare systems present high-accuracy and timely lung crab diagnosis for eligible patients.”

Median said it plans a marketplace rollout of eyonis LCS successful the US via a operation of nonstop endeavor sales, strategical organisation partnerships, and integration into existing objective environments.

Median said it volition utilise the existent US Centers for Medicare & Medicaid Services (CMS) reimbursement model – the bundle is assigned nether Medicare astatine a complaint betwixt $601 to $700. The institution volition proceed moving towards “broader, semipermanent security coverage”.

In January 2025, Median gained a €37.5m assistance from the European Investment Bank (EIB) and €10m from an equity enactment with IRIS Capital Investment that it utilized to enactment its FDA filing. The institution besides said astatine the clip that it would usage the funds to enactment the receipt of a European CE people for eyonis, which it present expects to get successful Q2 2026.

Median’s FDA clearance proceeds the FDA clearance of RevealDX’s comparable instrumentality for lung nodule valuation connected 3 February. The Washington-based company’s bundle analyses thorax CT scans for lung nodules and assigns them a Malignancy Similarity Index (mSI) to assistance radiologists find diligent follow-up recommendations.