Trajan expands US availability of Harpera Microbiopsy Punch for clinical skin sampling
FDA registration represents an important milestone in expanding access to the technology for healthcare professionals in the United States
31 Jul 2026
Trajan has announced that the Harpera™ Microbiopsy Punch is FDA-registered for marketing in the United States. This registration enables healthcare professionals across the US to use the minimally invasive skin microbiopsy device for a broader range of clinical skin sampling applications, alongside its established use in clinical research and wellness programs.
The expansion supports growing demand for patient-friendly skin sampling methods that maintain high-quality biological sample collection for modern molecular techniques.
Advancing minimally invasive clinical skin sampling
As healthcare and research organizations seek alternatives to traditional skin biopsy methods, the Harpera Microbiopsy Punch offers a minimally invasive, suture-free option for collecting cutaneous skin samples. The device is designed to help reduce collection burden while enabling access to high-quality biological samples suitable for dermatology, biomarker discovery, molecular analysis, translational research, and longitudinal skin sampling.
The Harpera tool uses a Microbiopsy approach that requires minimal pre- or post-procedure intervention. This design helps minimize disruption to patients and makes the device well suited for repeated sampling across research and clinical workflows, including precision dermatology and consumer health studies.
Supporting patient experience and sample quality
Healthcare professionals and researchers are increasingly focused on sampling approaches that improve the patient experience while maintaining or enhancing sample quality. The FDA registration of the Harpera Microbiopsy Punch in the US supports this shift by providing a clinically available option for minimally invasive skin sampling.
Since its introduction in 2021, Harpera devices have supported skin research globally and have been adopted by organizations advancing precision dermatology, consumer health, and translational research. FDA registration represents an important milestone in expanding access to the technology for healthcare professionals in the United States.
Quality, compliance, and intended use
The Harpera Microbiopsy Punch has been designed, developed, and manufactured in compliance with Trajan’s certified ISO 13485:2016 Quality Management System for medical devices and in vitro diagnostics. It is a manual surgical device intended to enable the collection of a specimen from the cutaneous skin surface by a healthcare professional and is FDA-registered for marketing in the US.
Outside of the United States, Harpera is made available as an investigational use only (IUO) product for use in performance studies.
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Frequently asked questions
What is the Harpera Microbiopsy Punch and how does its FDA registration impact clinical skin sampling in the United States?
The Harpera™ Microbiopsy Punch is a minimally invasive, suture-free manual surgical device from Trajan for collecting cutaneous skin specimens. Its FDA registration for marketing in the United States enables healthcare professionals across the US to use the device for a broader range of clinical skin sampling applications, expanding beyond its established role in clinical research and wellness programs.
How does the Harpera Microbiopsy Punch support precision dermatology, biomarker discovery, and longitudinal skin sampling?
The Harpera Microbiopsy Punch uses a minimally invasive Microbiopsy approach that requires minimal pre- or post-procedure intervention. This design reduces collection burden while providing high-quality biological samples suitable for dermatology, biomarker discovery, molecular analysis, translational research, and longitudinal skin sampling, making it well suited for precision dermatology and consumer health studies.
Who is Trajan and how does the Harpera device fit within its global life sciences and medical technologies portfolio?
Trajan is a global developer and manufacturer of analytical, life sciences, and medical technologies with more than 650 employees and sites across the Americas, Europe, Asia, and Australia.
The Harpera Microbiopsy Punch, designed under Trajan’s ISO 13485:2016 Quality Management System, is part of a broader portfolio spanning analytical science, sample collection, automation, and laboratory workflows to advance research and personalized, data-driven healthcare.