January brought 23 non-US approvals, including 13 CE marks, according to Medtech Insight's Approvals Tracker. The total for January 2018 also exceeds the 20 non-US approvals recorded a year ago.
[Editor's note: For sortable and searchable tables of all US and non-US approvals and clearances in 2017 and previous years, check out our Approvals Tracker/ For comprehensive tracking of company events and catalysts related to approvals and clearances, go to Meddevicetracker. Not a subscriber? Click here to request your free demo.]
2018 started off ahead of 2017 with 23 non-US approvals - including 13 CE marks - recorded in January by...
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.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
