Portfolio company Biolinq Incorporated granted De Novo Classification by U.S. FDA for its lead product
AXA IM Alts, a global leader in alternative investments with over €188 billion of assets under management, is pleased to announce its portfolio company Biolinq Incorporated (‘Biolinq’) has been granted De Novo classification by the U.S. Food and Drug Administration for its lead product Biolinq Shine™.
Biolinq is a developer of precision multi-analyte biosensors to improve metabolic health. Fully autonomous and needle-free, its glucose sensor will be initially marketed to people with type 2 diabetes who are not dependent on insulin. The U.S. Food and Drug Administration decision to grant De Novo classification marks a significant milestone for the company and unlocks the potential for scalable growth of a new generation of wearable glucose sensors.
Directly aligned with the United Nations’ Sustainable Development Goal 3: Good Health and Wellbeing, the support from AXA IM Alts’ global healthcare private equity strategy and impact investments has boosted Biolinq’s development in the market.
Dr Zina Affas Besse, Deputy Head of Healthcare Private Equity at AXA IM Alts, comments: “We are proud to see Biolinq granted De Novo classification by U.S. FDA for its intradermal glucose sensor, which marks a major milestone in its mission to address metabolic health. This aligns with AXA IM Alts’ goals to invest in solutions that contribute to improve global health, while also aiming to generate attractive financial returns.”
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Notes to editors
All figures at end-June 2025.
Biolinq Shine™ device has received De Novo classification from the FDA, officially designating it as a Class II medical device and enabling its commercial availability for patient use under prescription. The De Novo pathway is a regulatory process used by the FDA to classify novel medical devices that have no existing predicate and are deemed to have low or moderate risk.
About AXA IM Alts
AXA IM Alts is a business unit of AXA Investment Managers, part of the BNP Paribas Group since 1st July 2025 following the closing of its acquisition.
AXA IM Alts is a global leader in alternative investments with over €188 billion of assets under management comprising over €80 billion of primarily private real estate, €96 billion of private debt and alternative credit, as well as over €12 billion in Infrastructure and private equity.
We take a 360° approach to real estate & infrastructure investing with over €126 billion of assets under management in direct opportunities, held indirectly through debt and listed equities and via long term private equity investments into operating platforms. ESG is fully integrated into our investment decision making processes with a particular focus on decarbonization.
AXA IM Alts employs over 990 people located in 17 offices around the world and serves the needs of over 600 clients from Europe, North America, Asia Pacific and Middle East. We are the number one property portfolio and asset manager in Europe, and one of the largest worldwide.
All figures at end-June 2025
Highest-ranked Real Estate Manager in the European Union according to IPE’s Global Top 150 Real Estate Investment Managers, based on total value of real estate assets under management, November/December 2024
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