A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.
Eleven novel device or indication approvals were added to Medtech Insight's Approvals Tracker last week, including cardiology devices, soft-tissue repair products and the first standalone prosthetic iris.
Four of the approvals were accounted for by Stentys SAS's CE marks in Europe, for two catheters, a drug-eluting...
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After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.
The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.
Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.
