Cardiovascular and diabetes device dominated September's list of medical device approvals from outside the US on Medtech Insight's Approvals Tracker. The 24 non-US approvals in September is below average for 2017, but one more than September of 2016 and keeps 2017 on a track to have about 40% more non-US approvals than 2016.
[Editors' 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.]
Abbott Laboratories Inc. leads September's list of approvals from outside the US, according to Medtech Insight's Approvals Tracker, with...
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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.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
