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Medtech Insight

NZ To Replace Outdated And Piecemeal Device Rules

16 Jan 2019

There are significant changes in store for New Zealand’s medical device sector, including a new regulator and a set of pre- and post-market regulatory controls.

Medtech Insight

About Three Months Worth Of Carryover Device Fees Remaining FDAs Gottlieb Says

By David Filmore 16 Jan 2019

US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.

Medtech Insight

UK To Demand 'Responsible Person' Be Physically Located In Country Under No-Deal Brexit

By Amanda Maxwell 10 Jan 2019

The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.

Medtech Insight

2019 Will Be Testing Period For US FDAs Novel Pre-Cert Paradigm For Digital Health

By Ferdous Al-Faruque 10 Jan 2019

In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.

Medtech Insight

Global Approvals Infographic

07 Jan 2019

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

Medtech Insight

EU Regulatory Roundup November 2018

By Amanda Maxwell 05 Dec 2018

The medtech sector was already quite overwhelmed with the new EU regulations and Brexit uncertainties. Now add into the mix the impact of the global journalistic Implant Files investigation.

Medtech Insight

FDA Device Panel Delivers Thumbs Up For Breakthrough Heart-Failure Device

By Elizabeth Orr 05 Dec 2018

A US FDA panel overwhelmingly supported a heart-failure device designed to use cardiac contractility modulation to improve heart function. The Optimizer Smart system from Impulse Dynamics is apparently the first in FDA’s Breakthrough Devices program to go before an advisory panel.

Medtech Insight

Commissioner Says EU MDR/IVDR Implementation 'On Track,' But Fails To Convince Parliament

By Amanda Maxwell 31 Oct 2018

Elżbieta Bieńkowska, a European Commissioner, is "realistic and confident" when it comes to the implementation of the new EU medtech regulations. She says everything is going to plan. But that is not what members of the European Parliament are hearing.

Medtech Insight

Embrace The Digital Revolution, But On Your Own Terms, John Nosta Says

By David Filmore 31 Oct 2018

Digital health and innovation strategist John Nosta talks about the need for medical technology companies to stay true to their technology roots and not get too attached to the "patient centricity" bandwagon. Also: innovating organically and "failing smart."

Meddevicetracker, Medtech Insight

Neuromodulation Device Market Innovations and Trends Webinar

By David Filmore 29 Oct 2018

Join our presenters as they explore the area of neuromodulation, which is seeing significant growth at a time when other medical device markets are facing declining growth. The team focus on three targeted neuromodulation areas, including: spinal cord stimulation (SCS), deep brain stimulation (DBS) and vagus nerve stimulation (VNS).

Medtech Insight

Drug/Software Combo Pathway Coming Soon To US FDA, Gottlieb Says

By Derrick Gingery 26 Oct 2018

Under a new regulatory platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate pre-market device review.

Medtech Insight

Philippines Gets Moving On Reg Reform: Asian Medtech Associations Regulatory Networking, October 2018

26 Oct 2018

The Asian Medtech Associations Regulatory Networking discussions this month focus on regulatory reforms in the Philippines, where good progress is being made on embedding a new set of medical device, IVD and labeling regulations. Also, updates from Thailand, Hong Kong and India. This series is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).

Medtech Insight

Proposed 510(k) Changes Elicit Some Industry Skepticism

By Elizabeth Orr 18 Oct 2018

Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.

Medtech Insight

US FDA Shelves Proposal To Mandate Home-Use Device E-Labeling

By David Filmore 18 Oct 2018

A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.

Medtech Insight

Medtech Insight Awards 2018 Video

12 Oct 2018

The inaugural Medtech Insight Awards took place on September 23 in Philadelphia. It was an exciting evening of celebration, camaraderie and spirit, and the participation and enthusiasm of everyone present helped make the event a rousing success.

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