GlucoModicum's Needle-Free CGM Achieves 11.5% MARD in 646-Patient Clinical Trial, Nears EU Regulatory Filing
核心洞察
GlucoModicum (搜索) completed a clinical performance study with 646 participants using its needle-free continuous glucose monitor, achieving 11.5% MARD accuracy that approaches the 10% industry benchmark.
The magnetohydrodynamic technology-based device samples interstitial fluid non-invasively and combines readings with AI algorithms to provide blood glucose measurements without skin penetration.
The Finnish company plans to submit regulatory data to FIMEA (搜索) before year-end 2025, positioning itself to potentially deliver the world's first commercially viable needle-free CGM solution.
Finnish medtech company GlucoModicum (搜索) has achieved a significant milestone in needle-free glucose monitoring, completing a comprehensive clinical performance study involving 646 participants that demonstrated its continuous glucose monitor (CGM) device achieved 11.5% mean absolute relative difference (MARD), approaching the 10% industry benchmark set by current needle-based systems.
The clinical performance study, conducted in Q1 2025 in accordance with European Union In Vitro Diagnostic Regulation (IVDR), included both individuals with type 2 diabetes (搜索) and healthy volunteers, representing one of the largest clinical evaluations of its kind in the CGM industry. Participants used GlucoModicum (搜索)'s next-generation needle-free CGM across standard multi-hour glucose tolerance tests and ambulatory conditions involving exercise and meals.
Magnetohydrodynamic Technology Breakthrough
The CGM device, known as Talisman (搜索) and developed with Phillips-Medisize (搜索), utilizes magnetohydrodynamic (MHD) technology to non-invasively sample interstitial fluid—the body fluid between blood vessels and cells—for glucose levels. The reading is combined with other sensors and an artificial intelligence algorithm to provide blood glucose measurements. Like other CGMs, it is worn on the arm and transmits data wirelessly to a smartphone or other device, but crucially does not require a needle to pierce the skin.
"GlucoModicum (搜索) has solved the technical and manufacturing challenges that have long held back needle-free CGMs and done so at low cost, putting us at the forefront of the field and within reach of delivering the world's first truly needle-free continuous glucose monitoring solution," said Jokke Mäki, the company's chief executive.
Commercial-Scale Manufacturing Validation
All sensors used in the study were produced using GlucoModicum (搜索)'s proprietary mass-manufacturing blueprint, validating the company's commercial-scale production capability. The achieved 11.5% MARD corresponds to the best performing system using one-point calibration (n=208), though GlucoModicum's first commercial product is intended to be calibration-free.
"To the best of our knowledge, no other needle-free technology designed for use in the general diabetic population has passed beyond early lab-stage concepts," Mäki added. "GlucoModicum (搜索) is entering TRL 8 - the final stage before market launch. We believe our technology has enormous potential to make continuous glucose monitoring accessible to millions more people worldwide."
Regulatory Progress and Timeline
The positive clinical results follow key regulatory milestones achieved by GlucoModicum (搜索). In Q1 2025, the company successfully completed an ISO 13485 audit conducted by Eurofins Electric & Electronics Finland (搜索), a Notified Body designated by the European Commission according to the Medical Device Regulation (MDR). The audit concluded with zero non-conformities and zero deviations, establishing a foundation for the final stages of regulatory approval.
In Q2 2025, Finland's medicines agency FIMEA (搜索) granted GlucoModicum (搜索) authorization to initiate a new clinical investigation under Article 62 of the EU MDR, enabling the company to generate clinical data about the device's safety and performance required for CE marking and market entry.
The full study results will be reported to FIMEA (搜索) as part of the regulatory process, anticipated in the second half of 2025, with submission planned before the end of the year.
Clinical Impact and Market Potential
Compared to traditional finger-prick glucose testing, CGM devices can help people with diabetes (搜索) achieve better control of blood sugar levels, reducing the risk that levels can move out of safe ranges, causing hypoglycemia (搜索) or hyperglycemia (搜索), and potentially helping to prevent long-term complications like eye and nerve damage. The needle-free approach could significantly expand access to continuous glucose monitoring by eliminating the barrier of skin penetration that deters some patients from using current CGM technology.