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Approvals

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December 2019 Approvals Snapshot: Abbott Earns New Approval For CentriMag Circulatory Support System

December’s new medical device approvals include the FDA approval of Abbott Laboratories’ CentriMag circulatory support system for postcardiotomy patients, MicroVention’s FRED system for wide-necked intracranial aneurysms and an expanded indication for Foundation Medicine’s FoundationOne CDx cancer-drug companion diagnostic.

Approvals Innovation Research & Development

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US Senate Approves US-Mexico-Canada Agreement Championed By Industry

The US Senate overwhelmingly approved a bill on 16 January to implement the US-Mexico-Canada agreement, which includes a new chapter on the handling of medical devices supported by the medtech industry.

Policy Trade

FDA Revokes Emergency Authorization On Ebola, Zika Tests

Emergency Use Authorizations on two Ebola tests and one for the Zika virus have been revoked by the US agency because it cleared the tests via more permanent pathways.

Diagnostics Review Pathway

2020 Outlook: US Congress Will Address Surprise Billing, Ratify USMCA, Conduct More Medtech Safety Oversight

Congress was able to approve a permanent medical device tax repeal and pass a “LAB Act” bill favorable to the diagnostic industry in 2019. But what device-related legislation is ahead in 2020? Medtech Insight takes a look at some of the medtech bills and draft legislation likely to affect manufacturers pending in late 2019 that are likely to be reviewed – and perhaps approved – in 2020.

Policy Legislation

December 2019 Approvals Snapshot: Abbott Earns New Approval For CentriMag Circulatory Support System

December’s new medical device approvals include the FDA approval of Abbott Laboratories’ CentriMag circulatory support system for postcardiotomy patients, MicroVention’s FRED system for wide-necked intracranial aneurysms and an expanded indication for Foundation Medicine’s FoundationOne CDx cancer-drug companion diagnostic.

Approvals Innovation

QUOTED. 7 January 2020. Gaurav Singal.

Over the past year, next-generation sequencing (NGS) company Foundation Medicine has ramped up publishing research on genetic markers for cancer in peer-reviewed journals. Gaurav Singal, Foundation Medicine's chief data officer, says he’s particularly proud of the company's portfolio of solid tissue and liquid biopsy assays that complement each other to help diagnose and treat cancers. Check out his comment here.

Quoted Commercial

Partnerships Are Key To Foundation Medicine's Success

Since receiving approval for the first broad-panel diagnostic test as a combination product to detect cancer, Foundation Medicine has ramped up its partnerships with pharmaceutical companies and other stakeholders. The company expects to receive a similar approval for a broad-panel liquid biopsy genomic test in the first half of 2020.

Commercial Approvals

US FDA Exempts 200 Device Types From Premarket Notification

The US FDA has finalized regulations exempting hundreds of class I and class II medical devices from premarket notification requirements.

Regulation Review Pathway

Trump Signs Bill Bolstering US FDA Device Center Funding By 2% To $8M

The FDA’s device center is getting a 2% boost after President Trump on 20 December signed off on all appropriations bills for fiscal year 2020.

Policy Legislation

Tandem Wins FDA Clearance On First Stand-Alone Glycemic Controller

Tandem Diabetes Care received FDA clearance for its Control-IQ technology for use with Tandem's t:slim X2 insulin pump and Dexcom's G6 continuous glucose monitoring system, making it the first hybrid closed-loop system to deliver automatic correction boluses and adjust background insulin levels to help prevent high and low blood sugars.

Diabetic Care Regulation
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