Bayer AG said Sept. 18 it will not renew a CE mark for its Essure permanent contraceptive coils for women in EU countries, effectively halting sales of the product outside the US. The firm says its decision was "unrelated to product safety or efficacy," and driven by its commercial strategy. Meanwhile, US FDA calls for warnings and black box labels for Essure in the US, and says a Sec. 522 post-market study it ordered Bayer to complete "will help us better understand" thousands of complaints about the device.
Bayer AG will not attempt to renew its CE mark for the Essure permanent birth control method, ending the product's use in EU and other countries outside the US, the firm said Sept. 18. Bayer says there is "not much patient interest" in Essure in Europe.
Meanwhile, US FDA still supports uses of the product by American women, albeit with a black-box on the label with...
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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The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation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The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation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.
