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EU MDR

Dexcom CEO touts unprecedented performance of G7 in clinical trial, awaits FDA decision

January 10, 2022 By Sean Whooley

Exciting new data for the next-generation Dexcom (NSDQ:DXCM) G7 continuous glucose monitor (CGM) surprised even the company’s leadership. Dexcom Chair, President & CEO Kevin Sayer — presenting clinical study results for the G7 at the 40th Annual J.P. Morgan Healthcare Conference — has previously lauded the expected impact of the wearable glucose monitor, and the new data […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance Tagged With: CGM, Dexcom, EU MDR, FDA

MedTech 100 roundup: On the rise again

June 1, 2021 By Sean Whooley

Last week provided a glimmer of light for medtech after a rough few weeks as the industry continues to push in the right direction. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (May 28) at 108.5 points, producing a 0.7% rise from the 107.74-point mark […]

Filed Under: Business/Financial News, Featured, Funding Roundup, MassDevice Earnings Roundup, Mergers & Acquisitions, Wall Street Beat Tagged With: Barclay's, EU MDR, Honeywell, MedTech 100 Index, Medtronic, Olympus, Rapid Medical, Titan Medical Inc.

MedTech Europe warns on ongoing regulatory issues

May 26, 2021 By Nancy Crotti

MedTech Europe welcomed the first wave of new E.U. medical device regulations this week, but said there’s work that’s yet to be done. The trade group noted that EU MDR — the new regulatory regime for medical devices — strengthens the system of notified bodies, or companies that conduct audits on each device whose manufacturer […]

Filed Under: Business/Financial News, Diagnostics, Regulatory/Compliance Tagged With: EU IVDR, EU MDR, MedTech Europe

EU MDR finally goes into effect

May 25, 2021 By Nancy Crotti

The E.U.’s Medical Device Regulation (MDR) takes effect tomorrow, changing the process to gain entry to the continental market. EU MDR replaces the EU Medical Device Directive (MDD) with more stringent requirements on the companies that perform the audits for each device, also known as notified bodies. The change affects not only devices that are […]

Filed Under: Business/Financial News, Featured, Regulatory/Compliance Tagged With: EU MDR

EU allows remote audits for medical devices during pandemic

January 12, 2021 By Nancy Crotti

The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively. In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic […]

Filed Under: Business/Financial News, Diagnostics, Featured, Regulatory/Compliance Tagged With: bsi, EU IVDR, EU MDR, European Commission, European Union, MedTech Europe

MedTech Europe gives proposed European Health Union a partial nod

November 20, 2020 By Nancy Crotti

MedTech Europe has endorsed a new plan to strengthen the EU’s response to future pandemics and public health emergencies, with a few caveats. European Commission President Ursula von der Leyen outlined the plan to create a European Health Union in her state of the union speech on Nov. 11. The plan is a response to lessons learned from […]

Filed Under: Business/Financial News, Clinical Trials, Diagnostics, Featured, Regulatory/Compliance Tagged With: coronavirus, COVID-19, EU IVDR, EU MDR, European Commission, European Union, MedTech Europe

MedTech 100 roundup: Stocks remain high after record-setting week

November 16, 2020 By Sean Whooley

Medtech stocks have been on the rise since positive news regarding COVID-19 vaccines broke last week, breaking a record in the process. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 98.99 (Nov. 13), marking a 1.4% uptick from the 97.62 points registered at the […]

Filed Under: Business/Financial News, Contract Manufacturing, Featured, Funding Roundup, Initial Public Offering (IPO), MassDevice Earnings Roundup, Mergers & Acquisitions, Pharmaceutical, Research & Development, Wall Street Beat Tagged With: 3m, Baxter, coronavirus, COVID-19, EU MDR, Joe Biden, MedTech 100 Index, Sotera Health, Stryker, Wright Medical

How major medtech companies are responding to the looming EU MDR

November 10, 2020 By Nancy Crotti

Medtech companies that sell products in the European Union have a major deadline looming — one that’s already been put off once. The EU Medical Device Regulation (MDR) will replace the current EU Medical Device Directive (MDD) on May 26, 2021. Companies whose products are approved for sale in Europe must decide if they want […]

Filed Under: Business/Financial News, Featured, Regulatory/Compliance Tagged With: AdvaMed, becton dickinson, bsi, EU MDR, Johnson & Johnson, Medline Industries Inc., MedTech Europe, Smith+Nephew

BREAKING: EU-MDR is postponed by 1 year due to coronavirus pandemic

April 17, 2020 By Nancy Crotti

The European Parliament voted today to postpone implementation of its new Medical Device Regulation (MDR) by one year, giving medtech companies a welcome reprieve from their scramble to comply. EU MDR, originally scheduled to go into effect May 26, 2020, will now take effect May 26, 2021, if individual member states approve. Get the full […]

Filed Under: Business/Financial News, Featured, Regulatory/Compliance Tagged With: coronavirus, COVID-19, EU MDR, European Commission, European Parliament, MedTech Europe

DeviceTalks Weekly: Ep. 3 – Deconstructing medtech’s alphabet soup – DPA, MDR, FDA are all in the news

March 27, 2020 By Tom Salemi

In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry. Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less […]

Filed Under: Business/Financial News, Contract Manufacturing, Device Talks Podcasts, Featured, Legal News, Regulatory/Compliance, Respiratory Tagged With: coronavirus, COVID-19, DeviceTalks Weekly, EU MDR, Fang Consulting, FDA, Hogan Lovells

European Commission to ask for EU MDR enforcement delay

March 25, 2020 By Sean Whooley

The European Commission is putting together a proposal to ask the European Parliament and Council to delay enforcement of the new Medical Device Regulation (EU MDR) by one year in light of the coronavirus pandemic. Medical device companies have been scrambling to meet the implementation of the new MDR, scheduled for May 26. (The in […]

Filed Under: Featured, Regulatory/Compliance Tagged With: coronavirus, COVID-19, EU MDR, European Commission

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