BIOCORP
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
Quectel Takes Smart Meters to the Next Generation at Enlit 202519.11.2025 10:00:00 CET | Press release
Quectel Wireless Solutions, an end-to-end global IoT solutions provider, has announced it is attending the Enlit 2025 event in Bilbao, Spain on 18-20 November 2025 and will be at Stand 1.G86. Quectel is attending to showcase how its comprehensive range of modules, antennas and services are poised to assist continued massive uptake of smart meters and assist industry moves from first to second-generation devices. With deployments of smart meters, comprised of electricity, water and gas meters, exceeding 1.06 billion at the end of 2023 and set to continue in all regions, according to IoT Analytics, Quectel is seeing growth across all meter types and expansion of meter-based use cases. Smart electricity meters are being deployed in developing markets for the first time and mature markets are accelerating deployments of second-generation smart meters to help users optimize consumption and manage their own power generation via two-way metering communications. Growth is being experienced acr
Pacsun Successfully Implements Manhattan Active® Point of Sale, Unifying Commerce and Cutting Checkout Times19.11.2025 09:00:00 CET | Press release
Manhattan Associates Inc. (NASDAQ: MANH) today announced that Pacsun, a leading youth fashion retailer, has successfully deployed Manhattan Active® Point of Sale (POS), a cloud-native in-store sales and service solution that empowers associates to merge digital convenience with personalised retailing. Following a five-month project start to pilot phase, Pacsun rolled out Manhattan's POS solution across 300 plus stores in just eight weeks. Mobile checkout capabilities eased long in-store lines, while unified inventory management, powered by RFID integration, supported seamless fulfilment across Instagram, Amazon, TikTok and Pacsun’s own channels. During peak holiday season, Pacsun achieved record breaking revenue and streamlined operations, with 40% of online orders being fulfilled via stores, optimising inventory proximity, labour capacity and shipping costs that reduced logistics expenses by 25%. Stores are now critical drivers of retail differentiation, with industry research showing
Frontgrade Gaisler and DELTATEC Enable Advanced Space Computing Across Multiple Missions19.11.2025 09:00:00 CET | Press release
Frontgrade™ Gaisler Technologies a leading provider of high-reliability electronic solutions for space and national security missions, and DELTATEC,a very high-level design house specialized in advanced technologies are pleased to celebrate their successful collaboration in delivering high-performance computing solutions for space applications, with the GR712RC dual-core microprocessor at the heart of several flight-proven systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251119011567/en/ The GR712RC, developed by Frontgrade Gaisler and based on the fault-tolerant LEON3FT architecture, has been integrated into multiple Data Handling System (DHS) units designed by DELTATEC. These include one Payload Data Handling Unit (PDHU) and two On-Board Computers (OBCs) currently operating aboard ESA’s eSAIL mission, launched into Low Earth Orbit (LEO) in September 2020. Moreover, DELTATEC recently delivered the Flight Model of the
AGC Biologics and Repair Biotechnologies Partner on Novel mRNA Therapeutic to Combat the Leading Cause of Human Mortality19.11.2025 09:00:00 CET | Press release
Partnership leverages AGC Biologics’ cost-effective and dependable cGMP mRNA and LNP capabilities AGC Biologics today announced it is partnering with Repair Biotechnologies to tackle one of the world's most persistent health challenges and cause of mortality. The collaboration will focus on developing and manufacturing a novel mRNA therapy to rapidly stabilize and reduce the size of atherosclerotic plaques in major blood vessels. Rupture of unstable plaque and subsequent heart attack or stroke is the leading cause of death, accounting for 27% of all human mortality. “Developing a novel mRNA therapeutic as a part of the vital goal of curing atherosclerotic cardiovascular disease is a complex task, and robust manufacturing is critical to our progress,” said Reason, CEO and co-founder, Repair Biotechnologies. “We chose AGC Biologics because they have mastered the entire production chain for therapeutics of this class, eliminating critical risks and delays to provide a fast and reliable pa
Wasabi Introduces High-Performance Class and Expands into Silicon Valley to Take on AI’s Rising Data Storage Costs19.11.2025 09:00:00 CET | Press release
Wasabi Fire and AI-ready San Jose region give organizations a powerful alternative to hyperscalers, combining speed, simplicity, and predictable pricing for AI workloads Wasabi Technologies, the Hot Cloud Storage company, expanded further into artificial intelligence with the unveiling of Wasabi Fire, a high-performance storage class that supports AI workloads, available beginning in early 2026. Wasabi has also opened a new storage region in San Jose, Calif., as part of its relationship with IBM Cloud. The milestones reinforce Wasabi’s push to expand its role in AI infrastructure as demand for scalable, high-performance and cost-efficient cloud storage accelerates. “Object storage is the backbone of AI, but customers shouldn’t have to choose between speed and cost,” said David Friend, co-founder and CEO of Wasabi Technologies. “With Wasabi Fire, we’re delivering NVMe performance at disruptive prices, allowing organizations to cost-effectively store the critical data needed to train AI.
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