The ongoing failure of Swiss and European Commission decision makers to resolve the issue of Switzerland’s institutional agreement is hampering EU market access for Swiss innovators like IVDs company Abionic. More pressingly, the EU must address the wider issue of the MDR’s negative impact on innovation and start-ups, says Abionic co-founder Iwan Märki.
Swiss medtech innovators find themselves between two stools – one in Brussels and the other in Berne. Politicians on both sides are unable or unwilling to resolve the thorny issue of Switzerland’s institutional agreement with the EU, and for the medtech industry, the EU-Swiss mutual recognition agreement (MRA).
Lausanne-based Abionic SA has a pancreatic stone protein (PSP) test on its abioSCOPE platform to detect sepsis in the...
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.
