SpineGuard Obtains FDA Clearance for Commercial Release of its new “DSG Connect” Platform in the USA
15 Februar 2021 - 11:30AM
Business Wire
Regulatory News:
SpineGuard (FR0011464452 – ALSGD) (Paris:ALSGD), an innovative
company that deploys its DSG® (Dynamic Surgical Guidance) sensing
technology to secure and streamline the placement of bone implants,
announced today the clearance under 510K #201454 by the FDA (Food
and Drug Administration) for commercial release of its DSG Connect
platform in the United States.
The FDA clearance allows for commercial launch in the USA of a
new generation of PediGuard probes and smart screws for spine
surgery, capable of transmitting their X-Ray free, real time
information thanks to the DSG Connect module. A wireless tablet
interface embedded with a dedicated software application receives
the signal sent by the DSG sensor and adds visual rendering to the
audio feedback in order to optimize its exploitation in the
operating room. It also allows for data recording for the purpose
of medical legal evidence as well as the performance of clinical
studies on the topic of bone quality. Ultimately, the commercial
status in the United States of this platform already used
experimentally to guide orthopedic surgical robots facilitates its
potential integration within robotic and navigation systems in the
market place.
Stéphane Bette, cofounder and deputy CEO of SpineGuard,
declares: " This FDA clearance opens the doors of the American
market to our X-Ray free real time surgical guidance, from now on
connected and more powerful thanks to new functionalities. It also
affirms SpineGuard's position as a significant player in digital
surgery. DSG has the potential to be deployed throughout the entire
orthopedic and dental fields, and in particular in robotic
applications."
About SpineGuard® Founded in 2009 in France and the USA
by Pierre Jérôme and Stéphane Bette, SpineGuard is an innovative
company deploying its proprietary radiation-free real time sensing
technology DSG® (Dynamic Surgical Guidance) to secure and
streamline the placement of implants in the skeleton. SpineGuard
designs, develops and markets medical devices that have been used
in over 80,000 surgical procedures worldwide. Sixteen studies
published in peer-reviewed scientific journals have demonstrated
the multiple benefits DSG® offers to patients, surgeons, surgical
staff and hospitals. Building on these solid fundamentals and
several strategic partnerships, SpineGuard has expanded its
technology platform in a disruptive innovation: the « smart »
pedicle screw launched late 2017 and is broadening the scope of
applications in dental implantology and surgical robotics. DSG® was
co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D.,
and Alain Vanquaethem, Biomedical Engineer.
For further information, visit www.spineguard.com
Disclaimer The SpineGuard securities may not be offered
or sold in the United States as they have not been and will not be
registered under the Securities Act or any United States state
securities laws, and SpineGuard does not intend to make a public
offer of its securities in the United States. This is an
announcement and not a prospectus, and the information contained
herein does and shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be any sale of the
securities referred to herein in the United States in which such
offer, solicitation or sale would be unlawful prior to registration
or exemption from registration.
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version on businesswire.com: https://www.businesswire.com/news/home/20210215005126/en/
SpineGuard Pierre Jérôme CEO & Chairman Tel.: +33 1
45 18 45 19 p.jerome@spineguard.com
SpineGuard Manuel Lanfossi CFO Tél.: +33 1 45 18 45 19
m.lanfossi@spineguard.com
NewCap Investor Relations & Financial Communication
Mathilde Bohin / Louis Tilquin Tel.: +33 1 44 71 94 94
spineguard@newcap.eu
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