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Approvals

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OUS Approvals Analysis: Medtronic, Abbott, Abionic Lead 2017 Upswing

The 20 non-US medical device approvals in January, including eight in in vitro diagnostics, four in orthopedics, and three in cardiovascular devices. Big medtech players Medtronic and Abbott, accompanied by much smaller Swiss IVD firm Abionic, led the charge and bagged more OUS approvals than most.

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OUS Approvals Analysis: Medtronic, Abbott, Abionic Lead 2017 Upswing

The 20 non-US medical device approvals in January, including eight in in vitro diagnostics, four in orthopedics, and three in cardiovascular devices. Big medtech players Medtronic and Abbott, accompanied by much smaller Swiss IVD firm Abionic, led the charge and bagged more OUS approvals than most.

Approvals Research & Development

US Approvals Analysis: Slow 510(k) Month Includes Major Cardiac Assay Clearance

The number of 510(k) clearances in January by US FDA were lower than average, but there was at least one practice-changing advance deemed substantially equivalent last month: Roche's high-sensitivity Elecsys cardiac troponin assay. There were four original PMAs approved in January, but a lower-than-usual total of supplement approvals.

Approvals Innovation

Abbott Finally Joins MRI-Compatibility Club In US CRM Market

The firm’s Assurity MRI pacemaker and Tendril MRI pacing lead, acquired in its recent St. Jude Medical deal, gained US FDA approval after some delay. Lack of this designation has been a competitive challenge for the business in the past year.

Cardiology Approvals

To Alinity And Beyond: Abbott Dx Launches Into Its Next Phase

Abbott Laboratories' diagnostic business is rolling out its new line of Alinity systems across its core lab, point-of-care, and molecular markets. Executive VP Brian Blaser says the systems are the realization of an ongoing customer-centric shift by the business, and the firm highlights a turnaround for a diagnostics unit that, only a decade ago, Abbott was trying to wash its hands of.

Commercial Innovation

VolitionRx Gets Green Light For Nucleosome-Based Colorectal Cancer Test

Blood-based cancer diagnostics firm VolitionRx CE-marked a new colorectal cancer-screening test that has shown the potential to reduce unnecessary colonoscopies by up to 25% when combined with the fecal immunochemical test (FIT) score.

Cancer In Vitro Diagnostics

Abionic's New POC Sepsis Test On Rapid Move To Market

Swiss start-up Abionic has CE marked rapid tests for sepsis and iron deficiency, designed to run on its diagnostics platform abioSCOPE. The new sepsis test is based on a new biomarker PSP which has shown to be superior to current tests in detecting this life threatening condition early.

In Vitro Diagnostics Approvals

OUS Approvals Analysis: Slow Finish To 2016, But Still Ahead Of 2015

2016 finished with just two more non-US medical device approvals than 2015; December was by far the slowest month of the year for approvals from outside the US with just 11.

Approvals Europe

US Approvals Analysis: 2016 Another Record Year For FDA Novel Device Approvals

The agency approved a total of 91 original PMAs, panel-track PMA supplements and de novo classifications in 2016, outpacing last year's record for approvals of novel devices or indications, according to Medtech Insight's Approvals Tracker. Medtronic topped both the novel device approvals and 510(k) clearance lists for the year. Roche, Abbott, Siemens and GE also showed strong approval and clearance counts.

Approvals Research & Development

Infographic: 2016 Medical Device Approvals

Here's a graphical look at the global device approvals in 2016. It was another record year for novel devices in the US, while trends remained relatively steady in other regions.

Approvals Research & Development
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