Germany's CDU leader Angela Merkel secured her fourth term as chancellor, but chastened by an election result that saw many of her 2013 voters turn to the liberals and far right, her hand is weakened. Indeed, the EU's rock of political stability has sprung many a surprise in delivering a 2017 election result that will give businesses a sense both of unease and promise, with the re-emergence of the liberal and business-focused FDP.
The most obvious loser on German election day 2017, CDU leader Angela Merkel saw her CDU/CSU coalition tumble to its second-worst showing in a national election since 1949. But the Martin Schulz-led center-left SPD went one better – achieving its worst showing since the founding of the Bundesrepublik.
For German medtech, it is all to play for and rather too soon to make any plans, given the coalition...
With the latest ruling in Germany, there is speculation that the Medical Device Regulation’s confusing Article 11 on software or the device’s timing of gaining its class I category may be to blame for the invidious position Dermanostic has found itself in.
Proposals for substantial changes to oversight of medtech notified bodies are likely to be part of the European Commission’s targeted evaluation of the MDR and IVDR, EU medtech lawyer, Erik Vollebregt, tells Medtech Insight.
How Germany, which has the EU’s largest medtech manufacturing base, is pressing for the MDR to feature on the mission letter for the new European Commission and could influence the pace of change.
MPs from across Germany’s political spectrum grilled a panel of national medtech stakeholders on the problems of the MDR and the EU regulatory system during an hour-long sitting of the Bundestag’s health committee on 5 June.
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.
