Median Technologies Is Moving Forward With the FDA Interactions for Its iBiopsy® Lung Cancer Screening CADe/CADx Software as Medical Device
05 Mai 2022 - 05:45PM
Business Wire
- 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
FDA device clearance and market authorization, targeted for end
2023.
- On May 2, 2022, Median initiated a Q-submission process,
composed of several submissions, to request feedback from the FDA
on various topics such as the pivotal study protocols.
Regulatory News:
Median Technologies (ALMDT)
announces today that the company has received feedback from the
United States Food and Drug Administration (FDA) regarding the
513(g) submission done on Feb. 17, 2022 for its iBiopsy® Lung
Cancer Screening (LCS) AI/ML technology-based end-to-end
CADe/CADx1 Software as
Medical Device (SaMD).
The aim of the 513(g)
submission was to determine the relevant product classification and
choose between the De Novo or the 510(k) regulatory
pathways2 for iBiopsy® LCS
CADe/CADx SaMD. The FDA has stated that the Median’s iBiopsy® LCS
CADe/CADx falls within 21 CFR 892.2090 (Radiological Computer
Assisted Detection And Diagnosis Software), a Class II type device,
which requires the submission of a 510(k) in order to obtain the
FDA clearance prior to marketing.
As next regulatory steps,
Median Technologies is preparing several Q-submissions for Q2 and
Q3, 2022. The first Q-sub has been submitted for FDA review on May
2, and focuses mostly on reviewing pivotal study protocols and
possible predicate devices. A meeting will be scheduled with the
FDA experts at their earliest convenience.
“After this first regulatory feedback of the FDA on the 513(g),
we want to keep having frequent and fruitful interactions with the
Agency in order to better tailor our device to the US market”,
Fredrik Brag, CEO and founder of Median Technologies said. “The
design of the pivotal studies will be a key part of showing the
unique performance of our iBiopsy® CADe/CADx Software as Medical
Device and how it could have an impact on saving patients’ lives by
identifying lung cancer onsets at their earliest stage”, Brag
added.
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 2 510(k) and De Novo pathways are the only
regulatory pathways available to bring a device of low to moderate
risk level on the US market. Compared to the traditional 510(k),
the De Novo classification is a risk-based classification process
which is allowed for devices which have not filled the conditions
to be submitted via a 510(k). Source: FDA
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220505005781/en/
Median Technologies Emmanuelle Leygues Head of Corporate
Marketing & Financial 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)
Graphique Historique de l'Action
De Fév 2024 à Mar 2024
Median Technologies (EU:ALMDT)
Graphique Historique de l'Action
De Mar 2023 à Mar 2024