techUK

Event roundup: MHRA x techUK – introduction to software as a medical device (SaMD) regulation

In a member webinar hosted by techUK, experts from the Medicines and Healthcare products Regulatory Agency (MHRA) provided a ...
Finanznachrichten

Median Technologies to Showcase eyonis LCS, Its AI/ML-based Software as a Medical Device for Lung Cancer Screening, at the European Congress of Radiology

eyonis LCS commercial launch is ongoing in U.S. following FDA 510(k) clearance CE-marking regulatory process is on-going with a decision expected in Q2 2026 that could trigger commercial rollout of ...
Science Daily

Revealing the landscape of software as a medical device industry

There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...
Business Wire

Median Technologies to share positive pivotal data for eyonis™ LCS diagnostic software as medical device at the IASLC 2024 World Conference on Lung Cancer

eyonis™ LCS is a proprietary Software as Medical Device (SaMD) powered by artificial intelligence (AI) / machine learning (ML) for early detection and diagnosis of lung cancer eyonis™ LCS achieved ...
Finanznachrichten

Median Technologies: FDA Clearance Sets Stage for U.S. Commercialization of eyonis LCS Software as a Medical Device for Lung Cancer Screening; Oran Muduroglu Appointed ...

Oran Muduroglu, proven medical imaging entrepreneur, to lead U.S. launch of eyonis LCS Established U.S. commercial and clinical infrastructure combined with Medicare reimbursement pathway already in ...
Business Wire

Median Technologies to Showcase eyonis® LCS, Its AI/ML-based Software as a Medical Device for Lung Cancer Screening, at the European Congress of Radiology

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, “Median” or the “Company”), developer of eyonis®, a suite of artificial intelligence (AI)-powered ...
Morningstar

Median Technologies to Showcase eyonis® LCS, Its AI/ML-based Software as a Medical Device for Lung Cancer Screening, at the European Congress of Radiology

eyonis® LCS commercial launch is ongoing in U.S. following FDA 510(k) clearance CE-marking regulatory process is on-going with a decision expected in Q2 2026 that could trigger commercial rollout of ...