BIOCORP Obtains 510(k) FDA Clearance for SoloSmart®, Sanofi’s Smart Cap for Disposable Insulin Pens
January 25 2024 - 1:30AM
Business Wire
- In addition to SoloSmart's CE marking (Sept 2022), the FDA’s
authorization reinforces BIOCORP's technological leadership in the
smart pens market.
- This is the second FDA clearance1 for Biocorp’s Mallya
platform.
Press Release
BIOCORP (Paris:ALCOR), a Novo Nordisk company based in France
and specialized in the design, development, and manufacturing of
innovative medical devices, announced today that they have received
510(K) clearance from the U.S. Food & Drug Administration (FDA)
to market SoloSmart®, Sanofi’s smart medical device that connects
SoloStar® insulin pens.
Eric Dessertenne, CEO of BIOCORP, said: "This approval is a
major achievement for SoloSmart and our commercial partner, Sanofi.
We have brought together our unique expertise in medical devices
and innovative therapies to allow the commercial launch of
SoloSmart in the United States, answering to patients’ needs to
simplify their treatment journey. It also illustrates BIOCORP's
ability to meet the highest regulatory requirements and reinforces
the Mallya platform as the best in class in the smart pen
market”.
Designed, developed, and manufactured exclusively for Sanofi by
BIOCORP, SoloSmart is a smart sensor that is directly attached to
Sanofi’s SoloStar insulin pen platform, upgrading the pens into
connected devices. SoloSmart automatically collects and records key
treatment information (selected insulin units, date, and time of
injection) and transmits it to a dedicated digital application. It
offers HCPs an easy way to follow patients in the case of a
multitherapy treatment, for instance when using basal and rapid
insulins.
ABOUT BIOCORP
Recognized for its expertise in the development and manufacture
of medical devices and delivery systems, BIOCORP has today acquired
a leading position in the connected medical device market thanks to
Mallya. This smart sensor for insulin injection pens allows
reliable monitoring of injected doses and thus offers better
compliance in the treatment of patients with diabetes. Available
for sale from 2020, Mallya spearheads BIOCORP's product portfolio
of innovative connected solutions. BIOCORP was acquired by Novo
Nordisk in 2023.
For more information, please visit www.biocorp.fr.
_______________
1 BIOCORP obtained 510(k) clearance for Mallya first
version in December 2022. See PR edited on Dec 7, 2022, on
Biocorp’s website www.biocorp.fr.
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version on businesswire.com: https://www.businesswire.com/news/home/20240124383162/en/
PRESS CONTACT BIOCORP Sylvaine Dessard - Senior Director
Marketing & Communication - rp@biocorp.fr - + 33 (0)6 88 69 72
85
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