Business Wire

Median Technologies Announces Design Completion of its iBiopsy® Lung Cancer Screening End-to-end CADe/CADx Software as Medical Device (SaMD) with Outstanding Sensitivity ...

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (ALMDT:PA) announces outstanding performance of its iBiopsy LCS AI/ML tech-based end-to-end CADe/CADx Software as ...
Business Wire

Median Technologies Files FDA 513(g) Regulatory Submission for iBiopsy® Lung Cancer Screening CADe/CADx Software as Medical Device

513(g) submission is a key milestone that marks the initiation of Median’s interactions with the FDA. 513(g) submission will allow Median Technologies to determine the best FDA regulatory pathway for ...
Finanznachrichten

Median Technologies Announces Completion of the Q-Submission Phase with the FDA for its iBiopsy Lung Cancer Screening CADe/CADx Software as Medical Device

The Q-submission phase was initiated on May 2, 2022 with the FDA. The Q-submission phase aims at clarifying and implementing the FDA's expectations on key topics including pivotal study protocols.
PharmiWeb

Median Technologies Announces Onboarding of All Academic Sites Involved in the Pivotal Validation Plan for iBiopsy® LCS CADe/CADx SaMD

Kick-off meetings have taken place in all academic sites that will be participating in the pivotal validation plan towards regulatory approvals of iBiopsy® LCS CADe/CADx SaMD. World-class academic ...
Finanznachrichten

Median Technologies Is Moving Forward With the FDA Interactions for Its iBiopsy Lung Cancer Screening CADe/CADx Software as Medical Device

Median has received the FDA's feedback following the 513(g) regulatory submission for its iBiopsy LCS CADe/CADx Software as Medical Device. Median will proceed through a 510(k) submission to obtain an ...
National Institute for Health and Care Excellence

Artificial intelligence (AI)-derived software to analyse chest X-rays for suspected lung cancer in primary care referrals: early value assessment

The software included in this evaluation have AI‑derived algorithms to detect lung abnormalities for suspected cancer. All software technologies in clinical settings use fixed algorithms. They cannot ...