There is considerable focus at present on how far notified bodies can go in helping position their clients to have as smooth a conformity assessment passage as possible. It is a fine balancing act for all involved, but a new document gives useful insights.
Team-NB, the EU industry association for notified bodies, has issued the latest version of its code of conduct under the Medical Device Regulation (MDR) and the IVD Regulation for its members. This is the fifth edition.
One particularly interesting update to the document is a page citing what can be and cannot be provided in the...
Dutch insulin pump maker ViCentra secured $85m to scale European manufacturing, preparing for the 2026 launch of its thinner, lighter Kaleido 2 pump and push into US market. CEO Tom Arnold said the pump has more than 3,500 users in Europe and expects “tens of thousands” in the next 18 months.
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A proposed rule from Medicare would impact essential devices for many beneficiaries. AdvaMed says the rule would reduce incentives for companies to innovate and criticizes CMS for not providing the necessary information stakeholders need to fully understand the proposal’s implications.
Israeli device firm Fairtility recently obtained US FDA clearance for the CHLOE platform, which uses AI to make embryo assessments performed as part of in vitro fertilization more transparent, efficient and reliable.
Salient's inflammatory bowel disease test, built on the start-up’s Signal platform, is planned to launch in March 2026. The company leverages rich data from existing wellness tests to develop signatures, focusing on conditions that are often misdiagnosed and disproportionately affect women.
