Medipin News

Recent news and clinical updates for Medipin (the UK-based medical device company) highlight significant progress in the early detection of diabetic neuropathy and expanded clinical validation through late 2024 and 2025.

1. Breakthrough Clinical Evidence (October 2024 – 2025)

A major clinical study published in Primary Care Diabetes (Stacey Fisher et al.) provided high-level validation for the Medipin device.

• Superior Detection: The study involved nearly 400 participants and found that Medipin was significantly more sensitive than the traditional 10g monofilament test. It identified an elevated risk of neuropathy in 38% of patients, compared to only 14% identified by the monofilament method.

• Small-Fiber Targeting: Researchers concluded that Medipin’s ability to target small-fiber nerve function (the first to be damaged in diabetes) allows for much earlier intervention before permanent "Loss of Protective Sensation" (LOPS) occurs.

2. Launch of Home-Testing Initiative

Following the clinical success, Medipin has pivoted toward empowering patients with home-use kits.

• "Diabetic Toes Test": The company introduced a 12-pack monthly home-testing kit designed for self-monitoring.

• Compliance: The device is now actively marketed as a tool for patients to track their own neuropathic health between clinical visits, utilizing a "Verbal Analogue Scale" to quantify sensory loss.

3. Regulatory & Safety Updates

• Standards Compliance: Medipin remains a fully compliant Class I Medical Device under UK MHRA and EU MDR regulations. It is also FDA-listed in the United States.

• Infection Control Enhancements: Recent updates to the product design emphasize its "SuperSafe" disposal mechanism. The plastic point is designed to be neutralized by simple compression against a hard surface, eliminating the need for sharps bins in non-clinical environments (like homes).

4. Strategic Market Positioning

• NHS Study Participation (ODIN): The device is currently being utilized in a specific NHS-funded study (ODIN) to further refine the "Analogue Pinprick Comparison" technique.

• UK & International Distribution: Medipin has strengthened its distribution partnerships within the UK (notably with MediBargains and Algeos) to increase availability for both professional podiatrists and the general public.

5. Product Characteristics & Visual Testing

News from technical trade journals highlights the device's dual-purpose design. Beyond pinprick testing, its spherical head and bright red color are increasingly being utilized by clinicians as a standardized aid for visual testing (checking for scotoma and peripheral vision loss).