Citeline Podcasts

On this week's Medtech Insight podcast: industry response to signals and policies from the Trump administration; US Supreme Court justice nominee Judge Neil Gorsuch has ties to a 2015 preemption case involving Medtronic; legal experts predict an uptick in false-claims cases; details on a new Meddevicetracker report on cardiac rhythm management.

US FDA has reportedly selected three cities that will be home to new agency divisions dedicated to coordinating inspections of device manufacturers under its “program alignment” inspection initiative. This development is just one of many that will touch quality and regulatory professionals this year, longtime industry insider Steve Niedelman says in this Medtech Insight podcast. Other hot topics: FDA’s recent string of new guidances; the 21st Century Cures Act.

US FDA has reportedly selected three cities that will be home to new agency divisions dedicated to coordinating inspections of device manufacturers under its “program alignment” inspection initiative. This development is just one of many that will touch quality and regulatory professionals this year, longtime industry insider Steve Niedelman says in this Medtech Insight podcast. Other hot topics: FDA’s recent string of new guidances; the 21st Century Cures Act.

US FDA has reportedly selected three cities that will be home to new agency divisions dedicated to coordinating inspections of device manufacturers under its “program alignment” inspection initiative. This development is just one of many that will touch quality and regulatory professionals this year, longtime industry insider Steve Niedelman says in this Medtech Insight podcast. Other hot topics: FDA’s recent string of new guidances; the 21st Century Cures Act.

On this week's Medtech Insight podcast: Executive orders signed by President Trump during his first week in office impacted the device industry, from hiring freezes at US FDA, to fallout from the beginning stages of ACA repeal, to industry concern over the scrapping of the Trans-Pacific Partnership.

On this week's Medtech Insight podcast: Executive orders signed by President Trump during his first week in office impacted the device industry, from hiring freezes at US FDA, to fallout from the beginning stages of ACA repeal, to industry concern over the scrapping of the Trans-Pacific Partnership.

On this week's Medtech Insight podcast: Executive orders signed by President Trump during his first week in office impacted the device industry, from hiring freezes at US FDA, to fallout from the beginning stages of ACA repeal, to industry concern over the scrapping of the Trans-Pacific Partnership.

The approval of Biogen’s Spinraza for spinal muscular atrophy is a model case for demonstrating FDA’s speed in getting a compelling new therapy to market, the value of a responsive sponsor, and engaging positively with patient advocates in the storm of a controversial approval decision by the neurology division on a different product.

The approval of Biogen’s Spinraza for spinal muscular atrophy is a model case for demonstrating FDA’s speed in getting a compelling new therapy to market, the value of a responsive sponsor, and engaging positively with patient advocates in the storm of a controversial approval decision by the neurology division on a different product.

The approval of Biogen’s Spinraza for spinal muscular atrophy is a model case for demonstrating FDA’s speed in getting a compelling new therapy to market, the value of a responsive sponsor, and engaging positively with patient advocates in the storm of a controversial approval decision by the neurology division on a different product.