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
DEWA International Launched as a Wholly Owned Independent Subsidiary of DEWA to Develop Global Energy and Water Projects9.7.2026 18:07:00 CEST | Press release
HH Sheikh Ahmed bin Saeed Al Maktoum, Chairman of the Dubai Supreme Council of Energy, announced the establishment of ‘DEWA International’, a wholly owned independent subsidiary of Dubai Electricity and Water Authority (DEWA). The company aims to develop conventional and clean energy projects worldwide and export Dubai’s successful energy and water infrastructure model to global markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709099653/en/ DEWA International launched as a wholly owned independent subsidiary of DEWA to develop global energy and water projects (Photo: AETOSWire) HH Sheikh Ahmed bin Saeed Al Maktoum said: “Thanks to the vision and directives of His Highness Sheikh Mohammed bin Rashid Al Maktoum, Vice President and Prime Minister of the UAE and Ruler of Dubai, Dubai has become a global model for achievement and accelerated development. Through its world-class infrastructure, particularly in the energy
Echodyne Opens New Manufacturing Facility to Meet Surging Global Demand for Advanced MESA® Radar9.7.2026 15:00:00 CEST | Press release
New Washington State facility provides capacity to manufacture more than 30,000 radars annually, strengthening the U.S. defense industrial base As governments around the world accelerate investment in counter-unmanned aircraft systems (C-UAS) and short-range air defense, Echodyne today announced the opening of a new advanced radar manufacturing facility in Washington State, significantly expanding its manufacturing capacity to meet rapidly growing demand from U.S. and allied customers. With millions of drones manufactured and used by both sides in the Russian War in Ukraine, the need for enhanced safety for defense, national security, and critical infrastructure assets grows with every successful strike and interception. The low cost and high utility of drones dramatically alters the need for safety and security sensors. And as the low altitude economy takes off, hundreds of thousands of drones will perform a range of life-saving and commercial missions, requiring a sensor infrastructu
Orca Security Report: 99.9% of Fixable AI Vulnerabilities Remain Unpatched as AI Moves Into Production9.7.2026 15:00:00 CEST | Press release
Analysis of more than 1,200 production cloud environments provides a first-hand view into how organizations are embedding AI into business-critical workflows, exposing new security risks that traditional controls weren't built to address. Orca Security, a leader in cloud and AI security, today released its 2026 State of AI Security Report, offering a first-hand view into how AI is being deployed across more than 1,200 production cloud environments. The findings show AI is no longer limited to isolated pilots or developer experiments. Organizations are embedding AI into production applications, cloud services, and autonomous workflows faster than security programs can adapt. More than half (56%) of organizations have already deployed AI agents into production, while 51% use AI to build custom applications. At the same time, Orca found that 81% of organizations run vulnerable AI packages, and 99.9% of fixable AI vulnerabilities remain unpatched, highlighting how quickly AI has become ope
Viz.ai Expands into Neurodegenerative Disease with Cortechs.ai Collaboration9.7.2026 15:00:00 CEST | Press release
Cortechs.ai and Viz.ai partner to tackle multiple sclerosis and other neurodegenerative diseases across Viz.ai's health system network Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced a collaboration with Cortechs.ai, a global leader in neuroimaging and quantitative analysis solutions, to integrate Cortechs.ai's NeuroQuant and NeuroQuant MS suite into the Viz.ai platform, expanding access to quantitative neuroimaging for hospitals and health systems across the U.S. This partnership marks Viz.ai's expansion into neurodegenerative disease, growing Viz Neuro Suite beyond its already market-leading neuro offerings. The collaboration will begin with a focus on multiple sclerosis (MS), integrating quantitative MRI analysis from NeuroQuant MS directly into Viz.ai's care coordination workflow, giving clinicians both the quantitative precision and the coordination infrastructure needed to identify and manage MS patients at scale. “Viz.ai's co
SCP Standard Capital Partners AG: Fabian Becker Appointed Chairman of the Management Board and CEO9.7.2026 14:51:00 CEST | Press release
The Supervisory Board of SCP Standard Capital Partners AG (WKN: A12UPJ | ISIN: DE000A12UPJ7 | XETRA ticker: CAP) resolved today to appoint Mr. Fabian Becker as Chairman of the Management Board and Chief Executive Officer (CEO), effective as of 9 July 2026. Ms. Stephanie Schettler-Köhler will remain a member of the Management Board and will assume the role of Chief Operating Officer (COO). View source version on businesswire.com: https://www.businesswire.com/news/home/20260709982268/en/
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