The European Chemicals Agency’s committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) are evaluating sector by sector the proposed REACH restriction on PFAS and more than 5,600 public comments, reaching provisional conclusions on cosmetics at their June meetings. A date has not been set to consider PFAS uses in medical devices, which are numerous, essential, and in many cases devoid of alternatives, industry says.
The European Union’s proposed restriction on per- and polyfluoralkyl substances (PFAS) could eliminate medical devices required for minimally invasive surgeries, among many others, to the detriment of millions of patients, according to MedTech Europe.
MedTech Europe’s views were among more than 5,600 comments submitted by 25 September 2023 to the European Chemicals Agency...
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TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.
Tim Schmid, executive VP and worldwide chairman of J&J MedTech, expects Shockwave, acquired in April, and Abiomed, purchased in late 2022, to be “long-term gems” for the company. Cardiovascular is among higher-growth segments where J&J has concentrated investments in recent years, along with robotic surgical systems.
The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
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.
US FDA has greenlighted Senseonics’ Eversense 365 continuous glucose monitor, which must be replaced just once a year. Capable of being integrated with compatible insulin pumps as part of an automated insulin delivery system, the fully implantable device lasts 185 days longer than the Eversense E3 sensor and far outstrips competing CGMs, which last only for 10-14 days.
