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

Further to the Q-submission phase completion, Median’s iBiopsy LCS CADe/CADx SaMD pivotal study protocols are now finalized and ready for study execution.

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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

United statesCade cadxLcs cade cadxRadiological computer assisted detection and diagnosis softwareSoftware as medical device saDrug administrationBiopsy cade cadx software as medical deviceMedian technologiesUnited states foodBiopsy lung cancer screeningMedical deviceFredrik brag

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

United statesFrance generalCade cadxEmmanuelle leyguesLcs cade cadxGhislaine gasparettoCaroline carmagnolRadiological computer assisted detection and diagnosis softwareHead of corporate marketing financial communicationsSoftware as medical device saAi software as medical deviceDrug administrationBiopsy cade cadx software as medical deviceUnited states foodBiopsy lung cancer screeningMedical device

Median Technologies Reports Full-Year 2021 Results and Business Indicators for the First Quarter of 2022

Record high revenue of €5.7 million in Q1 2022, up 9.2% compared with Q1 2021 Further growth in the order backlog to €62.3 million as of March 31, 2022, up 18.4% compared with March 31, 2021

United statesFrance generalEmmanuelle leyguesCade cadxLcs cade cadxGhislaine gasparettoCaroline carmagnolHead of corporate marketing financial communicationsImaging contract research organizationRadiological society of north americaBiopsy lung cancer screeningEuronext growthMedian technologiesFredrik bragAnnual meetingRadiological society

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

iBiopsy LCS CADe/CADx SaMD could significantly contribute to eliminating barriers to the widespread adoption of lung cancer screening programs and save the lives of millions of patients

United statesCade cadxCade cadx software as medical device saDrug administrationMedian technologiesUnited states foodBiopsy lung cancer screeningMedical deviceFredrik brag

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