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Approvals

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OUS Approvals Analysis: IVDs Lead A Slow Month

Only 10 approvals from outside the US were recorded in May in Medtech Insight's approvals tracker. Half of those were for in vitro diagnostics, including three for companion diagnostic for cancer drugs.

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OUS Approvals Analysis: IVDs Lead A Slow Month

Only 10 approvals from outside the US were recorded in May in Medtech Insight's approvals tracker. Half of those were for in vitro diagnostics, including three for companion diagnostic for cancer drugs.

Approvals Innovation

US Approvals Analysis: 510(k) Clearances Spiked In May

In May, US FDA achieved its highest monthly total of 510(k)s clearances in more than two years. Here's a snapshot of the agency's approval and clearance activity last month from Medtech Insight's Approvals Tracker.

Approvals Medical Device

FDA Go-Ahead For Sentinel TAVR Filter Could Drive Procedure Volumes, Firm Says

Claret Medical plans to start rolling out the TAVR accessory immediately at clinical trial centers, with full market release expected in 2018. The company is also trying to get a Medicare add-on payment.

Approvals Medical Device

Biomarker Is King In Latest US FDA Cancer Drug Approval

Accelerated approval for patients with microsatellite instability-high or mismatch repair deficient solid tumors is the first time the US regulatory agency has granted an indication that does not specify the location of the tumor – a change that precision-medicine researchers have been eager to make.

Approvals Innovation

Blue Earth Extends Global PET Reach With EU Approval

Blue Earth Diagnostics, a molecular imaging agent specialist spun out of GE Healthcare, has secured EU approval to market its PET tracer for detecting recurrent prostate cancer. Axumin, which was approved in the US a year ago, is said to be only PET imaging agent for this indication in the EU.

Diagnostic Imaging Cancer

OUS Approvals Analysis: Small Companies Dominate International Approvals In April

April was a return to a more typical volume of medical device approvals outside the US after a particularly busy March. And the big names in medtech were mostly quiet in April's OUS approvals, according to Medtech Insight's Approval Tracker.

Approvals Innovation

US FDA Ready To Accept 510(k) Devices To Expedited Access/Breakthrough Pathway

Manufacturers considering the Expedited Access Pathway for 510(k) devices should start the submission process, experts and agency staff say, although it still remains to be seen what types of 510(k) devices will qualify. The December-enacted 21st Century Cures Act added 510(k) devices to the program as part of its Breakthrough Device provision.

Regulation Medical Device

Number To Know…4

The US FDA signed off on four de novo clearances in April, bringing the total number of devices approved via this pathway to 11 this year to date.

United States Approvals

US Approvals Analysis: April A Big Month For Non-Invasive Neurostim

Two de novo go-aheads granted by FDA last month sent non-implantable neurostimulation devices to market, one for headaches and the other for tear production. Overall, the agency granted four de novos in April, continuing a strong trend this year for that marketing pathway, according to Medtech Insight's Approvals Tracker.

Approvals Innovation
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