BIOCORP
7.12.2022 07:31:39 CET | Business Wire | Press release
Regulatory News:
BIOCORP (FR0012788065 – ALCOR / Eligible PEA‐PME), a French company 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 Mallya, its smart medical device that connects insulin pens.
Eric Dessertenne, CEO of BIOCORP, said: "This approval is a major achievement for BIOCORP and all of our employees who have been heavily involved in this regulatory process. This approval marks a historic achievement for BIOCORP as it allows the commercial launch of our Mallya device in the United States and illustrates BIOCORP's ability to meet the highest regulatory requirements. This news has been eagerly awaited by all our industry partners to commercialize Mallya in the world's largest diabetes market and we are delighted that U.S. patients will soon be able to benefit from Mallya's services. This regulatory milestone will have a positive impact on our sales outlook in 2023 and positions BIOCORP as a leader in the field of smart pens.”
The Mallya medical device is a smart sensor that is directly attached to insulin pen injectors, making them connected devices. Mallya automatically collects and records key treatment information (selected insulin units, date, and time of injection) and transmits it to a dedicated digital application. Mallya becomes the first system approved in the U.S. capable of automatically connecting different types of insulin & GLP-1 drugs, with an initial version of Mallya compatible with SANOFI’s Solostar pen injectors.
Mallya is already the only device in its class to be CE marked as a Class IIb medical device. It offers the possibility to connect to different types of injection pens and thus to follow a patient in a multitherapy notably with a use of basal and rapid insulin.
BIOCORP has already signed major partnerships in the field with leaders of the diabetes space such as NOVO NORDISK, SANOFI AND ROCHE Diabetes Care.
BIOCORP's 510K approval will accelerate the submission of Mallya's future generations in the diabetes field and in other therapeutic areas where the company has signed partnerships.
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. The company has 80 employees. BIOCORP is listed on Euronext since July 2015 (FR0012788065 – ALCOR).
For more information, please visit www.biocorpsys.com.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221206005937/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Thales Builds Cryptographic Security for the Age of AI and Post-Quantum Computing14.9.2026 09:00:00 CEST | Press release
Thales launches Luna 8, a new hardware security module (HSM) to provide future-ready, quantum resistant security to protect critical data and applications Powered by a Thales designed cryptographic processor, it delivers unparalleled performance, enhanced protection and the flexibility to adapt to new security needs Drawing on decades of cryptographic expertise, Luna 8 combines trusted security with support for emerging technologies, including post quantum cryptography According to the 2026 Thales Data Threat Report, the threat of Harvest Now, Decrypt Later (HNDL) attacks was the top-cited risk, with 59% of organizations reporting that they are prototyping and evaluating post-quantum cryptography (PQC) algorithms to prepare for the quantum era. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804748922/en/ ©Thales To help organizations turn this readiness into deployment,Thales, a global leader in advanced technologies, tod
U.S. FDA Accepts New Drug Application Under Priority Review for Takeda’s Zasocitinib in Moderate-to-Severe Plaque Psoriasis, with Potential to Redefine Oral Treatment Expectations14.9.2026 09:00:00 CEST | Press release
Acceptance is based on pivotal Phase 3 data demonstrating rapid, durable and consistent skin clearance, including in high-impact sites, in a convenient once-daily pill Results from nearly 3,000 patients support potential for next-generation TYK2 inhibitor to redefine oral treatment expectations in psoriasis The Prescription Drug User Fee Act (PDUFA) target action date is in the first quarter of calendar year 2027 Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) under Priority Review for zasocitinib (TAK-279) for the treatment of adults with moderate-to-severe plaque psoriasis. Zasocitinib is an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, which demonstrated rapid, durable and consistent skin clearance in Phase 3 plaque psoriasis studies.1-3 Addressing unmet needs in psoriasis treatment “Despite progress in psoriasis care, there remains a need for highly
SWISSto12 and Mitsubishi Electric Corporation Announce Strategic Partnership14.9.2026 09:00:00 CEST | Press release
The Memorandum of Understanding (MoU) and additional contract signal a new phase of collaboration on market development in the Asia Pacific (APAC) region SWISSto12 today announced a memorandum of understanding (MoU) with Mitsubishi Electric Corporation (MELCO) (TOKYO: 6503) to pursue joint opportunities on advanced payloads, radio frequency (RF) products, and market development in Japan and the APAC region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914982179/en/ Masahiko Arai, Executive Officer and Group President, Defense & Space Systems, Mitsubishi Electric, and Dr. Emile de Rijk, Chief Executive Officer, SWISSto12 Joint opportunities will leverage MELCO’s extensive satellite system expertise and integration capabilities together with SWISSto12’s proprietary 3D-printing designs and processes that form the foundation of its next-generation payloads—smaller, lighter, highly performant, yet built in materially shorter
Focused Support Launches Cavok STRIKE to Expand Link-16 Participation Across the Joint Force14.9.2026 07:00:00 CEST | Press release
Extending Link-16 interoperability without platform-level hardware integration Focused Support LLC today announced the launch of Cavok STRIKE, an integrated software capability that expands the Link-16 tactical battlespace picture by enabling additional operational platforms to participate in the Link-16 network. Modern battlefields have increasing numbers of unmanned systems, sensors, and supporting platforms operating throughout the joint battlespace. The rapid proliferation of Group 1, 2, and 3 UAS, including both expendable and recoverable systems, has created a growing need to integrate these assets into the broader tactical network. Many of these platforms provide operationally relevant information but have historically remained outside the Link-16 network due to limitations in size, weight, power, platform integration complexity, or acquisition cost. Cavok STRIKE addresses this gap by enabling platforms to participate in the Link-16 network as non-command-and-control participant
Fujirebio Expands Access to Blood-based Neurology Testing in Brazil with ANVISA Market Authorization for Lumipulse® G NfL Blood and Lumipulse G pTau 217 Plasma14.9.2026 07:00:00 CEST | Press release
H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted market authorization for the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for use on the fully automated LUMIPULSE® G immunoassay platform in Brazil. “ANVISA authorization of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays marks another important step in our mission to expand access to reliable, clinically meaningful blood-based biomarkers for clinicians and patients worldwide,” said Christiaan De Wilde, CEO of Fujirebio Europe N.V. “By making both neurological biomarker assays available to laboratories on a single, fully automated platform, we are helping support more informed clinical decision-making across a broad range of neurological conditions and throughout the diagnostic pathway.” The Brazilian ANVISA authorizations are based on the already CE marked in vitro diagnostics (IVD) approvals of these two
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom