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Executive Summary
Here's a graphical look at the global device approvals in 2016. It was another record year for novel devices in the US, while trends remained relatively steady in other regions.
Trends in medical device approvals say something about the direction of industry and the performance of regulators. Here's a graphical look at some key data points linked to device approvals in 2016, in the US, Europe and beyond.
For an analysis of the US approval trend see "US Approvals Analysis: 2016 Another Record Year For Novel Devices." For a closer look at the numbers out of the US, see "OUS Approvals Analysis: 2016 Finishes Slowly, But Still Beats 2015."
For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out our Approvals Tracker.
Medtech Insight: global medical technology news & analysis
The US agency has relaxed its enforcement policy for X-ray, ultrasound and magnetic resonance imaging systems, as well as software for analyzing images, as US health care workers fight the novel coronavirus.
Topics Coronavirus FDA
Medtech Insight: global medical technology news & analysis
By Sue Darcey
The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.
Topics Approvals Clinical Trials Coronavirus Policy & Regulation
Medtech Insight: global medical technology news & analysis
As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.
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