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
Interactive Brokers Expands AI Integration Capabilities – Adding ChatGPT and Grok to Its Growing Suite of Agentic Trading Tools22.6.2026 16:00:00 CEST | Press release
Additional Asset Classes Available Including Options and Futures Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced the expansion of its agentic trading capabilities with the addition of ChatGPT and Grok, further broadening a growing ecosystem of AI platform integrations that began with Claude. Available through certified AI connector marketplaces across multiple leading platforms, these integrations allow clients to research, analyze, and generate instructions with speed and efficiency to uncover new trading and investing opportunities instantly. With this release, Interactive Brokers also extends the selection of products available for order instructions to include support for options, futures and futures options in addition to equities and ETFs. “We continue to see growing interest from investors in using artificial intelligence as a more natural way to interact with financial markets,” said Milan Galik, Chief Executive Officer of Interactive Brokers. “A
IQM Named Among Quantum Collaborators in HPE's New Hybrid Quantum-HPC Platform22.6.2026 15:22:00 CEST | Press release
The collaboration will advance practical and scalable hybrid classical-quantum applications. This follows IQM's first on-premises quantum computer installation in the United States, at Oak Ridge National Laboratory. IQM has sold 23 quantum systems globally to date and intends to list on Nasdaq in the United States by mid 2026. Hewlett Packard Enterprise has named IQM Quantum Computers among the companies collaborating on its hybrid classical-quantum computing platform, announced at HPE Discover Las Vegas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260622035759/en/ IQM Radiance quantum computer at HPE Discover Las Vegas 2026 IQM, a global leader in full-stack superconducting quantum computers, is contributing superconducting quantum processor technology to the effort, in which HPE is integrating multiple quantum modalities with its Cray supercomputing infrastructure. This collaboration strengthens IQM's global expansion p
Return Abuse Goes Mainstream as Nearly Half of Consumers Use AI in Return Claims, New Riskified Research Finds22.6.2026 14:30:00 CEST | Press release
New global study shows normalization of strategic returns, widening regional differences, and rapid AI adoption reshaping ecommerce post-purchase risk Riskified (NYSE: RSKD), a global leader in ecommerce fraud detection and risk intelligence, today released a new global report, “Rewriting the Rules on Returns”, exploring how consumer attitudes and behaviors around ecommerce returns are evolving in the age of artificial intelligence (AI). The Riskified-commissioned study, conducted by eTail Insights, is based on a survey of 2,091 consumers across seven countries, alongside in-depth interviews with senior leaders from many of the largest retail companies in the world. The research finds that return abuse behaviors are increasingly normalized, while nearly half of consumers already use generative AI tools to assist with return or refund claims. At the same time, merchants are responding by tightening return policies, shortening return windows, and deploying advanced AI detection to better
Forrester Unveils Agendas For 2026 Technology & Innovation Forums In North America And EMEA22.6.2026 14:00:00 CEST | Press release
The Forums will equip technology leaders with the capabilities needed to operationalize AI and build high-performing IT organizations that deliver measurable business outcomes Forrester (Nasdaq: FORR) today announced the full conference agendas for its Technology & Innovation Forum Central (Austin, September 14–15, 2026), Technology & Innovation Forum EMEA (London, September 30–October 1, 2026), and Technology & Innovation Forum East (New York City, November 4–5, 2026). This year’s theme, “The IT Singularity,” dives into the new AI era in which AI has become ubiquitous and no longer a competitive advantage on its own. To succeed, technology leaders including chief information officers, chief data officers, and chief AI officers need to integrate AI into their operating models, modernize software development and IT operations, strengthen data and governance practices, and align technology investments with business strategy. Across the Forums, tech leaders and their teams will learn how
AdvanCell Establishes U.S. Global Headquarters and Secures Flagship Manufacturing Facility in Greater Boston to Drive Growth Strategy22.6.2026 14:00:00 CEST | Press release
New 128,000-square-foot facility in Andover will serve as U.S. global headquarters and future manufacturing center supporting the development and commercialization of ADVC001 and the Company’s pipeline of Lead-212 targeted alpha therapies Expanding U.S. operations complement the Company’s established Australian R&D and manufacturing capabilities to create a global, vertically integrated platform for radiopharmaceutical development and commercial supply AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced the establishment of its U.S. Global Headquarters in the Greater Boston area, and the lease of a new 128,000-square-foot facility that will become the Company’s U.S. flagship manufacturing center supporting its long-term growth and commercialization strategy. The expansion marks an important milestone in the Company’s evolution into a U.S.-based radiopharmaceutical company with integrated operations spanning
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