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
Samsung and Mistral AI Announce Strategic Partnership for Intelligence-Driven Semiconductor Infrastructure8.9.2026 18:15:00 CEST | Press release
Collaboration will focus on development and implementation of on-premises AI technologies across Samsung’s chip operationsSamsung makes lead investment in Mistral’s funding round Samsung Electronics Co., Ltd., today announced it has entered into a strategic partnership with Mistral AI to enhance its semiconductor engineering and manufacturing capabilities that will reinforce its leadership in AI chip technologies. The announcement of the partnership was made during the state summit held in Paris between South Korea and France. Under the agreement, Samsung will integrate Mistral’s AI services and solutions—including its flagship large language model, Mistral Large—across its semiconductor operations to develop customized on-premises AI models optimized for intelligence-driven infrastructure. Mistral’s powerful AI platform is expected to provide Samsung with a unique stack of tools that will transform how semiconductors are designed and manufactured. The on-premises enterprise solutions
Sensereo Airo Wins IFA Berlin Innovation Award8.9.2026 17:00:00 CEST | Press release
Prestigious Accolade Recognizes Sensereo’s Next-Generation Approach to Creating Healthier, Smarter Indoor Environments Sensereo, an environmental intelligence company developing next-generation sensing products for safer, healthier and smarter living, was presented with the prestigious IFA Berlin Innovation Award for its Airo modular indoor air quality system. The award was presented during IFA Berlin on Thursday, Sept. 4, recognizing Airo for its innovative approach to helping consumers better understand and manage the quality of their indoor environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260906292649/en/ Winner of a 2026 IFA Innovation Award, Airo is Sensereo’s flagship environmental intelligence platform, combining advanced sensing technology with a modular design that allows users to monitor multiple aspects of indoor air quality and environmental conditions through a single, consumer-friendly system. Desig
Verdantis Rebrands as the AI Super-Agent for MRO, Sets Sights on AI-Native Enterprise Asset Management8.9.2026 16:06:00 CEST | Press release
Nine AI agents now run the MRO decision chain for Fortune 500 plants; new tagline “Anticipate. Resolve. Learn.” Verdantis, the AI company for spare parts and MRO inventory optimization in asset-intensive industries, today unveiled its new brand identity as the AI Super-agent for MRO and announced it is building toward a fully AI-native Enterprise Asset Management (EAM) platform. Verdantis’s super-agent orchestrates nine specialized AI agents across the decisions that decide plant uptime: spare parts, criticality, demand, reorder, and work order planning. These decisions set working capital, maintenance spend, and whether a critical asset runs and, in most plants, they are still made in spreadsheets and disconnected systems. The positioning is for the teams who own uptime - maintenance, reliability, and MRO supply chain leaders in oil and gas, mining, utilities, chemicals, and manufacturing. And it reflects an AI-first architecture: agents decide and act by default; people supervise, ov
HyperLight Welcomes VentureTech Alliance to Series C, Deepening TFLN Integration Across the Semiconductor Ecosystem8.9.2026 16:00:00 CEST | Press release
HyperLight Corporation ("HyperLight"), a leader in thin-film lithium niobate (TFLN) photonics, today announced that VentureTech Alliance ("VTA") has joined its Series C financing round. VTA is a venture investment firm focused on the semiconductor industry, with a portfolio built across the semiconductor technology stack — including circuit design, foundry-adjacent process technology, EDA, advanced packaging, and photonics. VTA's participation extends the ecosystem alignment that defined the round, which brought together investors spanning silicon ICs, foundry manufacturing, electronics manufacturing services, networking, and global infrastructure capital. With VTA's addition, the syndicate now reaches further into the semiconductor manufacturing and design-enablement layers on which high-volume photonics production depends. "The transition to TFLN is not a component decision — it is an ecosystem decision," said Mian Zhang, CEO of HyperLight. "Getting TFLN into volume requires the proc
EcoOnline Appoints Conor O’Loughlin as CEO8.9.2026 16:00:00 CEST | Press release
O’Loughlin brings founder, product and commercial experience spanning startup growth, global SaaS scale and M&A EcoOnline, a global provider of software that transforms how organisations protect people and the planet, today announced the appointment of Conor O’Loughlin as Chief Executive Officer, effective immediately. O’Loughlin succeeds Tom Goodmanson and will lead the Company into its next chapter of growth and innovation, continuing EcoOnline’s mission of keeping employees safe across the globe and supporting more than 11,000 customers. O’Loughlin is an experienced, growth-oriented technology operator and founder. He co-founded fitness technology company Glofox, scaling it into a global SaaS business serving customers in more than 80 countries before its acquisition by ABC Fitness in 2022. Following the acquisition, he served as Platform President and later Global Chief Revenue Officer at ABC Fitness, leading strategy across the company’s revenue-generating activities. “Keeping peo
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