Median Technologies Files FDA 513(g) Regulatory Submission for iBiopsy® Lung Cancer Screening CADe/CADx Software as Medical Device
03 Mars 2022 - 5:45PM
Business Wire
- 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 iBiopsy® LCS CADe/CADx Software
as Medical Device.
- Median aims to obtain a full device approval and market
authorization by the end of 2023, and proceed with subsequent
commercialization.
- 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.
Regulatory News:
Median Technologies (ALMDT)
announces today that the company has filed a 513(g) submission on
Feb. 17, 2022 to the United States Food and Drug Administration
(FDA) for its iBiopsy® Lung Cancer Screening (LCS) AI/ML
technology-based end-to-end CADe/CADx1 Software as Medical Device (SaMD).
The 513(g) submission will
allow Median Technologies to determine the best product
classification and choose between the De Novo or the 510(k)
regulatory pathways for iBiopsy® LCS CADe/CADx SaMD. The FDA is
expected to review the 513(g) submission and provide feedback
within 60 calendar days.
As next regulatory steps,
Median Technologies is preparing several Q-submissions for Q2,
2022.
“This first regulatory submission marks the beginning of our
interactions with the FDA. The FDA’s feedback will help us
determine the shortest and most efficient way to bring our product
onto the US healthcare market”, Fredrik Brag, CEO and founder of
Median Technologies said. “Lung cancer is the deadliest cancer, and
being able to detect it very early is of critical importance for
patients. Our innovative iBiopsy® AI/ML-based technology could have
a huge impact on saving patients’ lives by identifying lung cancer
onsets at their earliest stage, and could significantly improve the accuracy,
consistency, and adoption of lung cancer screening programs
worldwide”.
About iBiopsy®: iBiopsy® is based on the most advanced
technologies in Artificial Intelligence (AI) and Data Science (DS),
benefiting from Median’s expertise in medical image processing.
iBiopsy® targets the development of innovative AI/ML-based Software
as Medical Device, to be used in several indications for which
there are unmet needs regarding early diagnosis, prognosis and
treatment selection in the context of precision medicine. iBiopsy®
currently focuses on lung cancer, liver cancer (HCC) and liver
fibrosis (NASH).
About Median Technologies: Median Technologies provides
innovative imaging solutions and services to advance healthcare for
everyone. We harness the power of medical images by using the most
advanced Artificial Intelligence technologies, to increase the
accuracy of diagnosis and treatment of many cancers and other
metabolic diseases at their earliest stages and provide insights
into novel therapies for patients. Our iCRO solutions for medical
image analysis and management in oncology trials and iBiopsy®, our
AI-powered software as medical device help biopharmaceutical
companies and clinicians to bring new treatments and diagnose
patients earlier and more accurately. This is how we are helping to
create a healthier world.
Founded in 2002, based in Sophia-Antipolis, France, with a
subsidiary in the US and another one in Shanghai, Median has
received the label “Innovative company” by the BPI and is listed on
Euronext Growth market (Paris). FR0011049824– ticker: ALMDT. Median
is eligible for the French SME equity savings plan scheme
(PEA-PME), is part of the Enternext® PEA-PME 150 index and has been
awarded the Euronext European Rising Tech label. For more
information: www.mediantechnologies.com
1 A radiological CADe device is “intended to identify, mark,
highlight or otherwise direct attention to portions of an image
that may reveal abnormalities during interpretation of images by
the clinician.” A CADx device is “intended to provide information
beyond identifying abnormalities, such as an assessment of
disease.” Source: FDA
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version on businesswire.com: https://www.businesswire.com/news/home/20220303005636/en/
Median Technologies Emmanuelle Leygues Head of Corporate
& Marketing Communications +33 6 10 93 58 88
emmanuelle.leygues@mediantechnologies.com
Press - ALIZE RP Caroline Carmagnol +33 6 64 18 99 59
median@alizerp.com
Investors - ACTIFIN Ghislaine Gasparetto +33 6 21 10 49
24 ggasparetto@actifin.fr
Median Technologies (EU:ALMDT)
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