A pilot trial of the swissdamed database – an initiative designed to mirror the EU’s Eudamed – was successfully completed in June, allowing the regulator Swissmedic to confirm live implementation in January 2024. Work on two swissdamed modules is underway.
The Swiss authorities have made good progress in setting out the structures needed for the future Swiss Database on Medical Devices (swissdamed). This tool to regulate medtech in Switzerland was a provision of the national medical devices and IVD ordinances (MepV and IvDV).
A pilot project in June 2023 involved 17 companies who tested Module 1 (Modul ACT) on the registration of companies...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 30 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.
The firm’s dual-chamber leadless pacemaker system with is expected to be a growth driver for Abbott and already has acquired approximately 30%-40% of market share from Medtronic since its approval by the US FDA in July 2023, according to GlobalData.
Amferia is developing an antimicrobial peptide hydrogel dressing to combat infections in acute wounds in humans and veterinary contexts. Supported by €1.2m of new venture capital financing, the company is planning pivotal clinical studies to support an FDA application later this year and CE mark submission in 2026-2027.
