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59 Total results for product and free and sample content found

Medtech Insight

Critical EU Authorities Meeting Next Week Could Be Make-Or-Break For Many Medtech Companies

By Sue Darcey 21 Sep 2018

The EU medtech industry is trying to put the brakes on the full application of the new Medical Devices and IVD Regulation as a logjam looms. What is it doing to succeed? And why is time running out?

Topic Medtech

Medtech Insight

Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary

By Ferdous Al-Faruque 30 Aug 2018

AdvaMed's top lobbyist says a new documentary critical of the medical device industry and US FDA's device review pathways is unlikely to result in Congressional action. However, the group is talking to members on Capitol Hill to make sure they fully understand the context within which devices are reviewed and marketed.

Topic FDA Medtech

Medtech Insight

Mock Audits: Has Ambiguity In EU Led To Unfair Advantage?

By Amanda Maxwell 22 Aug 2018

There's been confusion and conflicting opinions about notified bodies conducting mock audits on companies' documentation to prove conformity with the impending EU Medical Device and IVD Regulations. Has the lack of clarity led to different and unfair practices? Does it matter?

Topic Medtech

Medtech Insight

Canada Consults On Mandatory Reporting Of Device Incidents By Hospitals

By Vibha Sharma 22 Aug 2018

The Canadian government has made it mandatory for hospitals to report medical device incidents and serious adverse reactions in their control irrespective of where these incidents originate.

Topic Medtech

Medtech Insight

Kavanaug's Potential Rulings On ACA's 10 Essential Benefits Could Impact Medtech Coverage

By Sue Darcey 22 Aug 2018

An analysis of Supreme Court nominee Brett Kavanaugh’s prior rulings opposing the Affordable Care Act, and how his weight on ACA cases coming before the high court may remove some marketplace insurance for medtech products for preexisting illnesses and mental health that are currently covered. The third of a multi-part Medtech Insight feature series on what a more conservative Supreme Court could mean for future court decisions that impact the medical device industry.

Topic Medtech

Medtech Insight

Global Approvals Infographic

25 Jul 2018

Meddevicetracker recorded 62 medical device approvals from outside the United States in the first quarter for 2018, including 46 CE Marks from Europe.

Topic Medtech

Medtech Insight

US Starts Imposing China Medtech Tariffs, But Offers Path To Product Exclusions

By Sue Darcey 10 Jul 2018

Although the 25% tariffs initiated July 6 by the US Trade Representative will impact about $836m worth of medical technology entering the US from China, the administration late last week offered a process for gaining exclusions for specific products. AdvaMed members are “looking into” the process, the group said, and Medical Imaging and Technology Alliance members have already started to try to use it.

Topic Medtech Strategy

Medtech Insight

Brexit: Will UK Now Stockpile Devices? And Is It Certain The Country Will Continue With MDR?

By Amanda Maxwell 06 Jul 2018

UK starts to discuss emergency measures around devices as no-deal Brexit concerns mount. But it is still looking like the UK will continue to implement the Medical Device Regulation, in the short-term at least. Will it be a different matter for the IVD Regulation?

Topic Brexit Medtech

Medtech Insight

Mercy, J&J Partner To Evaluate Medical Devices

By Ferdous Al-Faruque 06 Jul 2018

As US FDA has been on a quest to encourage gathering more real-world data, companies like Medtronic and Johnson & Johnson seem to be hopping on the bandwagon with partnerships to gather and analyze how their products really perform.

Topic Medtech

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