Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
White Paper: Evidence requirements for medical devices in the regional HTA program in Italy
Get insights from MTRC White Papers to advance your understanding of five rapid HTA reports from the Tuscany region
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Rapid HTAs of seven medical devices released in Tuscany in December 2025
The Tuscany Regional Healthcare HTA body issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With Regional Decree 27042 of December 23, 2025, Tuscany Regional Healthcare published seven new rapid HTA reports on medical devices in cardiovascular, neurosurgery, neuromodulation, orthopedics, urology, and surgical fields.
Some examples of evaluated technologies are provided below:
- Vycor ViewSite Brain Access System with Alignment Clip (VBAS AC) by Vycor Medical, for surgical access to deep brain lesions in patients with brain injuries and deep hemorrhagic lesions;
- VersaCross Steerable Access Solution (from Boston Scientific), a procedural kit with a radiofrequency guidewire and sheath designed to facilitate transseptal catheterization procedures, for patients with non-standard or anatomically complex atrial septum (thick, floppy, postcardiac surgery, or with a device in the atrial septum).
See the regional decrees and all assessments in Italian and English here.
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