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
H2SITE Secures New Strategic Investment to Accelerate Industrial Deployment of Hydrogen Production and Separation Solutions25.6.2026 06:00:00 CEST | Press release
H2SITE, a leading industrial company in hydrogen production and separation solutions, has completed a second closing of its Series B round. The transaction brings in EIC Fund with a private investor who will support the company’s next phase of growth and increases H2SITE’s total funding raised in this round to more than €42 million. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260624444396/en/ H2SITE These new partners, join BEV, Suma Capital, Hy24, Crane, Enagás Emprende, Calderion and CRPV who participated in the first closing, further validating the confidence of the European innovation ecosystem in H2SITE’s ability to industrialize and deploy key hydrogen solutions at commercial scale. Over the past years, H2SITE has successfully demonstrated the maturity and scalability of its technology, achieving more than 50,000 operating hours with its membrane reactors and separators, establishing advanced manufacturing capabilit
FPT Expands Strategic Collaboration with Microsoft to Advance AI Frontier Innovation Across Asia25.6.2026 04:00:00 CEST | Press release
FPT Corporation today announced an expanded strategic collaboration with Microsoft aimed at accelerating enterprise AI adoption and co‑innovation across Asia, with a strong focus on ASEAN, Japan, and South Korea. The collaboration brings together Microsoft’s global AI platforms with FPT’s large‑scale delivery and regional market capabilities to support organizations as they move from AI experimentation to real‑world, scalable impact, with measurable business outcomes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260624200416/en/ Representatives of FPT and Microsoft at the signing ceremony, formalizing an expanded strategic collaboration to advance AI Frontier innovation across Asia The collaboration aligns with FPT’s AI‑First strategy and Microsoft’s vision for human‑agent collaboration, with the goal of enabling enterprises to redesign how work is done across engineering, operations, and business functions. Positioning FP
Murata Expands Product Information Management API Service to Cover All 73 Product Categories25.6.2026 04:00:00 CEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) now covers all 73 product categories in its Product Information Management (PIM) API Service. By using this API service, engineers, developers, and procurement specialists can retrieve up-to-date product information, enabling prompt responses to product status changes and reducing the risk of component obsolescence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260624146819/en/ [Murata Manufacturing Co., Ltd.] Murata expands Product Information Management API Service to cover all 73 product categories As digital transformation accelerates in the manufacturing industry, a wide variety of systems and platforms are being used across the entire workflow - from design and component selection through to procurement. Previously, Murata’s PIM API Service covered only surface-mount and leaded ceramic capacitors and inductors. This narrow service coverage required user
Swedish Court Further Reschedules Delivery of Judgment in PriceRunner Vs Google Antitrust Case24.6.2026 20:55:00 CEST | Press release
Klarna provides investor update Klarna Group plc (NYSE: KLAR) wishes to update investors that the Patent and Market Court in Stockholm, Sweden (Patent- och marknadsdomstolen) has again postponed publication of its judgment in the antitrust damages proceedings brought by PriceRunner, a Klarna subsidiary, against Google. The Court has rescheduled publication of its judgment from June 26, 2026 to July 1, 2026 at 13:00 CET. As with the Court's two previous notifications, the rescheduling is a procedural decision by the Court and relates solely to the timing of the judgment delivery. In its notification, the Court cited high workload as the reason for needing additional time to finalize the judgment. No inference about the outcome should be drawn from it. Important Notice The outcome of the proceedings is inherently uncertain. No assurance can be given that PriceRunner will succeed on liability or quantum. Any award would be subject to appeal by Google, to sharing arrangements with former P
Vertex Energy Announces 6,000 bpd Group III Base Oil Expansion Project24.6.2026 16:00:00 CEST | Press release
Vertex Energy, Inc. (“Vertex” or the “Company”) today announced it is advancing a project at its Mobile, Alabama refinery to produce crude-derived conventional Group III base oils through the Company’s existing hydrocracker and related processing infrastructure, providing lubricant manufacturers and blenders with an additional domestic source of high-quality Group III supply. The project is designed to add an incremental 6,000 barrels per day of conventional Group III production capacity and support production of 4 cSt, 6 cSt, and 8 cSt Group III base oils using an existing crude-derived hydrocracked vacuum gas oil stream produced at the Company’s Mobile, Alabama refinery. Combined with the Company’s existing re-refined Group III base oil production, this additional capacity is expected to make Vertex the leading Group III producer in North America. Vertex has completed preliminary design work and has procured a high-pressure lubricants hydrotreating unit. The Company plans to start pr
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