The International Medical Devices Database from the International Consortium of Investigative Journalists – an output of ICIJ's recent string of "Implant Files" stories that were critical of industry – offers information on more than 700,000 device recalls, field safety notices and safety alerts documented in 11 countries. While device-makers and shrewd consumers will discover a bevy of useful data in the public repository, it could prove confusing for laypeople. A recalls expert and an ex-FDA official weigh in.
Device-makers and industry-savvy consumers will discover a bevy of useful information in a new international database of product recalls and safety notices, but the public repository could prove confusing for laypeople, experts say.
The International Medical Devices Database (IMDD) from the International Consortium of Investigative Journalists is an output of ICIJ's recent...
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. 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.
Medical device regulatory reliance and recognition of third-party regulators’ approvals have been making news in the UK, but in certain other markets the practice is well established. International regulatory experts explained their experiences at the MedTech Forum 2024.
The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation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.
