Call for Papers on Early Feasibility Studies for Medical Devices

Clinical Therapeutics is inviting submissions for a special issue on Early Feasibility Studies for Medical Devices. This issue aims to delve into the characteristics, patterns, and growth of EFS studies, comparing regulatory systems between the US and Europe, and evaluating the impact of the FDA EFS Program.

Key Aspects

• Focus: Initial clinical safety and performance of medical devices in early development.
• FDA EFS Program: Established in 2013 to foster innovation and early access for American patients.
• Topics: Success in attracting early clinical investigations, safety issues, patient benefits, and feedback mechanisms.

Case studies on technologies that reached the market post-EFS are welcomed, as well as submissions with a focus on initial clinical safety and performance of medical devices in early development.

𝗚𝘂𝗲𝘀𝘁 𝗘𝗱𝗶𝘁𝗼𝗿𝘀:
Giuditta Callea, Associate Professor and Carlo Federici, Research Fellow, from SDA Bocconi, and members of the HEU-EFS coordination team.

𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗗𝗲𝗮𝗱𝗹𝗶𝗻𝗲: September 30, 2025
For more details, visit the Clinical Therapeutics journal page https://www.sciencedirect.com/special-issue/321847/early-feasibility-studies-for-medical-devices-goldmine-or-fool-s-gold.

Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe

#EFS #HealthcareInnovation #MedicalResearch #EvidenceGeneration