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Approvals

Set Alert for Approvals

FDA Expands TAVR Indication To Low-Risk Patients

As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.

Approvals Clinical Trials Innovation
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Hong Kong Poised To Speed Up Device Approvals

The Medical Device Control Office is to launch a trial program for expediting the approval of certain classes of medical devices.

Approvals Regulation

FDA Approves CVRx’s Barostim Neo For Heart Failure On Expedited Pathway

The PMA approval is based on the results of the BeAT HF trial, which showed that baroflex activation therapy with Barostim Neo safely improves quality-of-life scores and exercise capacity in patients with heart failure and reduced ejection fraction.

Approvals Clinical Trials

Pediatric Scoliosis Device Nabs HDE Approval

The US FDA has approved Zimmer Biomet’s Tether device, which is the first device of its type cleared to treat children with a form of spinal curvature. It's also the first pediatric spinal device to net Humanitarian Device Exemption approval from the agency in 15 years, the company says.

Orthopedics Approvals

FDA Expands TAVR Indication To Low-Risk Patients

As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.

Approvals Clinical Trials

Device Week, 9 August 2019 – Safety Concerns With Cardiac Devices; User Fees Go Up

In this week's podcast, Medtech Insight’s Ferdous Al-Faruque chats with Elizabeth Orr about the the latest safety concerns over cardiac devices such as drug-eluting stents and implantable cardioverter defibrillators. They also discuss the agency’s recently released user-fee rates and how they’ve increased historically.

Device Week Regulation

Australia Clears Nexstim Neuromodulation Depression Treatment

Neuromodulation firm Nexstim has received regulatory clearance for its SmartFocus TMS system for treating major depressive disorder (MDD) in Australia.

Australia Approvals

Medtech Firms To See Significant User Fee Increases In FY 2020

Most categories of medical device user fee applications will be 6% more expensive starting in October. Establishment registration fees will see more than a 7% increase as well, regardless of whether a company is considered a small business.

Regulation Approvals

Global Approvals Snapshot July 2019

An overview of the global medical device approvals in July, as captured by Medtech Insight's Approvals Tracker.

Approvals Innovation

Angle Edges Closer To US FDA Clearance For Liquid Biopsy System

Angle is moving closer to becoming the first company to receive US FDA-clearance for a system that captures and harvests intact circulating tumor cells from patient blood for analysis.

Clinical Trials Research & Development
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