Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Approvals

Set Alert for Approvals

Global Device Approvals: Weekly Snapshot

A snapshot of global medical device and diagnostics approvals recorded in Medtech Insight's Approvals Tracker during the past week.

Approvals Innovation Research & Development
Advertisement

Latest From Approvals

Global Device Approvals, Weekly Snapshot: April 16-22, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

Approvals Innovation

Victory From The Jaws Of Defeat: Angel Med Wrests Approval For Implantable Heart-Attack Monitor

A US FDA advisory panel unanimously voted down the AngelMed cardiac monitor two years ago. But venture-backed Angel Medical Systems was able to engage with the agency after the panel, and the firm ultimately achieved approval of the device designed to help detect heart attacks earlier. It’s a lesson in firms leveraging all the data they have at their disposal.

Approvals Advisory Committees

Global Device Approvals: Q1 Snapshot

The first quarter of 2018 brought 90 approvals from outside the US, including 56 in Europe, according to Medtech Insight's Approvals Tracker. The biggest category of approvals was cardiovascular, with several new drug-eluting stents and heart-valves coming through during the first three months of the year. Check out our infographic spotlighting the Q1 trends.

Approvals Clinical Trials

US Device Approvals: Q1 Snapshot

An infographic to spotlight US FDA device approval trends during the first quarter, January through March.

Approvals Innovation

Global Device Approvals, Weekly Snapshot: April 9-15, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

Approvals Innovation

Global Device Approvals, Weekly Snapshot: April 2-8, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

Approvals Innovation

Device Debut: Curetis' Unyvero Infectious Disease Tester Earns De Novo Clearance

FDA granted de novo clearance to Curetis' Unyvero "sample-to-answer" diagnostic system and the Lower Respiratory Tract Infection Application Cartridge, the company announced April 3. Unyvero works with the Unyvero LRT Application Cartridge to provides rapid infectious disease testing directly from aspirate samples in less than five hours. The FDA decision comes a day after the Singapore Health Sciences Authority approved Curetis' Unyvero BCU Cartridge.

Approvals In Vitro Diagnostics

Cardiva's Vascade System Now Approved For Vein Closures After Cardiac Surgery

After receiving US FDA approval to help close arteries following cardiac surgery five years ago, Cardiva Medical says its Vascade system is now also approved to close veins that are typically larger with thinner walls after surgery.

Approvals Clinical Trials

Gottlieb Wants To 'Bring Medtech Manufacturing Home' In 2019 Budget Request

US FDA would use a proposed $128m, 39% budget authority increase in 2019 Center for Devices funding over the prior year to promote domestic device manufacturing, and let low-risk digital health products receive streamlined approvals, among other budget priorities, says FDA Commissioner Scott Gottlieb.
United States Approvals
See All
UsernamePublicRestriction

Register