LEUVEN, Belgium, Oct. 1, 2024 /PRNewswire/ -- Relu, a pioneer in
artificial intelligence (AI) assisted segmentation for dental labs
and software companies, proudly announces the dual achievement of
510(k) clearance by the U.S. Food and Drug Administration (FDA) and
CE Mark approval by an EU Notified Body. These regulatory
milestones authorize the commercial distribution of the Relu®
Creator, the cutting-edge dental tool that enables users to create
3D anatomical models from patients in just minutes.
FDA clearance signifies compliance with U.S. medical device
standards, while the CE Mark confirms adherence to EU regulations
for product safety and consumer protection. This dual recognition
underscores Relu's commitment to excellence in the oral health
sector.
"We are thrilled to have attained both FDA and CE approval for
the Relu® Creator," stated Adriaan Van
Gerven, CTO and Co-founder, of Relu. "These significant
achievements are a testament to Relu's dedication to creating
superior technology that meets the highest international safety and
quality standards. We're poised to revolutionize patient and
dentist experiences across both continents."
"This approval paves the way for our advanced technology to
enter US and EU dental markets with the highest potential for
growth. Having led strategy in Dental, AI and Orthodontic sectors,
I consider this achievement a key differentiator that sets Relu®
Creator apart. This is a major step forward in Relu's mission to
modernize dental care," said Bindu
Saran, former Global Head of Orthodontic Technology at
Straumann, former Sr. Manager of R&D at Ormco, and Board Member
at Relu.
The Relu® Creator integrates cutting-edge AI to deliver features
such as automated anatomical identification, and enhanced 3D
imaging for dental diagnostics and treatment planning. By improving
precision and increasing overall efficiency in dental procedures,
Relu® Creator is set to be an essential tool for modern dental
clinics.
About Relu
Relu is founded in 2019 with the dream of making dental
treatments safer and faster. They plug in advanced computer vision
and artificial intelligence to automate manual workflows. Their
Relu® Engine and Relu® Creator are used by dental lab and software
partners for more than thousands of orthodontic and implant
treatments every day. Relu is headquartered in Leuven, BE with an
office in Boston, MA, USA. Learn
more at relu.eu.
© 2024 Relu
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