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Approvals

Set Alert for Approvals

OUS Approvals: Edwards And Trinity Lead Spring Surge

With 50 non-US approvals recorded by Medtech Insight in March, there were almost twice as many medical device approvals outside the US last month as in February and more than any month in the last year. Cardiovascular devices were in the lead, together with IVDs, and highlights on March's list include several new peripheral vascular technologies, including PQ Bypass' peripheral bypass system.

Approvals Innovation Research & Development
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Latest From Approvals

Japan’s New 'Fast-Break Scheme' To Reduce Clinical Trial Burden For Medtech

Japan’s “fast-break scheme” is coming soon and will be the country’s fourth procedure for accelerating the approval of important medical devices.

Approvals Clinical Trials

Edwards Gets Early Present With FDA Clearance

While Edwards Lifesciences was hoping for a 510(k) clearance later in the year, the company got the greenlight to market its new hemodynamic monitoring system, HemoSphere, in the first quarter.

Cardiovascular Cardiology

ElectroCore's gammaCore Gets US Clearance For Cluster Headaches

The de novo clearance is the first US clearance for electroCore's non-invasive vagus nerve stimulation therapy. The company will market it through headache specialists as a non-pharmacological alternative to sumatriptan for patients with cluster headaches, which afflict about 350,000 people in the US.

Neurology Innovation

Device Debuts: Tryton, Myriad Genetics, Integra Lifesciences, Acelity, And Toyota

This edition of device debuts highlights a wide variety of innovative devices introduced into commercial markets since the beginning of March, including a new stent for side-branch coronary interventions, an assay that identifies which breast-cancer patients do not need chemotherapy, a full ankle prosthesis, improvements to a negative-pressure wound therapy system, and a robotic system that helps paralyzed people learn to walk again.

Research & Development Clinical Trials

Number To Know…50

50 is the number of non-US approvals in March, as recorded by Medtech Insight's Approvals Tracker.

Approvals Number to Know

OUS Approvals: Edwards And Trinity Lead Spring Surge

With 50 non-US approvals recorded by Medtech Insight in March, there were almost twice as many medical device approvals outside the US last month as in February and more than any month in the last year. Cardiovascular devices were in the lead, together with IVDs, and highlights on March's list include several new peripheral vascular technologies, including PQ Bypass' peripheral bypass system.

Approvals Innovation

US Approvals Analysis: Biotronik Making Its Interventional Mark

The German-headquartered firm is making a play to enter the US vascular intervention market, with two stents approved by FDA under original PMAs in the first quarter of 2017. Cardiovascular devices, in general, have gained the most novel-device approvals so far this year, followed by IVDs. Check out more from a Q1 look at US FDA approvals and clearances monitored by Medtech Insight's Approvals Tracker.

Cardiology Cancer

iCAD Touts PMA-Approved Tool As Time-Saver For 3D Breast Assessment

iCAD won US FDA approval for its PowerLook Tomo Detection computer-aided detection tool for the growing field of digital breast 3D tomosynthesis product. It's intended to address a key complaint by radiologists with tomosynthesis: the long time it takes to read 3D, compared to 2D exams.

Cancer Diagnostic Imaging

Pulse Biosciences' Shoots For US Clearance Of Nano-Pulse Platform

Pulse Biosciences' nano-pulse technology, PulseTx, precisely targets and kills cells with short electrical pulses that induce cell death and induce an immunogenic response. The company has submitted a 510(k) application to the US FDA for the technology, seeking a broad soft-tissue ablation indication, but it is developing PulseTx for immunoncology and dermatology indication.

Cancer ImmunoOncology
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