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 ...

SOPHIA-ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (ALMDT) announces today that the company has received feedback from the United States Food and Drug Administration (FDA) ...

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.

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 ...

New results, obtained on a very large cohort of 9,863 patients show drastically improved performance of the iBiopsy® LCS CADe/CADx Software as Medical Device (SaMD) with a sensitivity of 96.5% at ...

· 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 ...

Lung cancer is one of the most common types of cancer in the UK. It causes symptoms such as persistent cough, coughing up blood, and feeling short of breath. People in the early stages of the disease ...

In low- to middle-income countries (LMICs), most breast cancers present as palpable lumps; however, most palpable lumps are benign. We have developed artificial intelligence–based computer-assisted ...

Endoscopists' predictions of polyp histology were more accurate than those of a computer-aided diagnostic tool (CADx) in real-time colonoscopy, but overall accuracy was highest when the endoscopists ...