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Approvals

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US Approvals Analysis: Abbott Leads Another Strong Month For Novel Approvals

Abbott Laboratories accounted for two of five original PMA approvals recorded by US FDA in August. That update and more from Medtech Insight's Approvals Tracker.

Approvals Innovation Research & Development
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Easier-To-Clean Duodenoscope Gets US FDA Clearance

The device from Pentax features a disposable distal cap, thus cutting the risk of infection transmission between patients. An earlier Pentax duodenoscope model was the subject of an infection-related safety alert in January.

Safety Approvals

Medtronic Launches Advanced Chronic Pain Management System

The next-generation Intellis could strengthen Medtronic’s grip on the spinal cord stimulation market, where it already holds a 30.2% share.

Medical Device Neurology

Australia Sees Surge In Level 3 Audits For Active Implantables

Australian regulators completed more Level 2 compulsory audits of applications to include class III and active implantable medical devices on the Australian Register of Therapeutic Goods in 2016-17.

Australia Approvals

Device Week, September 14, 2017 – Product Approvals Spotlight

On this week's podcast, we discuss Medtech Insight's August analysis of global device approval trends.

Approvals Device Week

OUS Approvals Analysis: Medtronic, MicroPort Lead August's Line-Up Of International Approvals

There were 16 CE marks and seven medical device approvals in regions outside of the US and EU in August, according to Medtech Insight's Approvals Tracker. Although 23 approvals in a month is below average for the 2017 OUS tracker, it's more than appeared in August 2016 or 2015, and keeps 2017 on track for 351 approvals from outside the US.

Approvals Innovation

First Anti-Addiction App Approved In The US

Pear Therapeutics' reSET mobile application to treat substance addictions in combination with outpatient therapy programs has been approved by US FDA. The agency approved the software after a multi-site clinical trial showed patients were significantly more successful remaining abstinent after using the app.

Regulation Approvals

US Approvals Analysis: Abbott Leads Another Strong Month For Novel Approvals

Abbott Laboratories accounted for two of five original PMA approvals recorded by US FDA in August. That update and more from Medtech Insight's Approvals Tracker.

Approvals Innovation

Siemens Unveils First 7-Tesla MRI Scanner For The Clinic

The company claims the images created by Magn etom Terra reveal fine details in anatomy and function that will help usher in the next era of precision medicine. The new system has earned a CE mark while a 510(k) is pending.

Research and Development Strategies Innovation

Creo Gets Early FDA Green Light For Endoscopy Device

Surgical endoscopy specialist Creo Medical has received the nod of approval to start selling its Speedboat RS2 device and CROMA platform in the US. The FDA cleared the use of the surgical endoscopy device ahead of schedule, processing the company's 510(k) application just 49 days from submission.

Approvals Commercial
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