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European Commission

Medtronic offers EU concessions in $43 billion Covidien deal

November 11, 2014 By MassDevice Leave a Comment

Medtronic offers EU concessions in $43 billion Covidien deal

Filed Under: Mergers & Acquisitions, News Well Tagged With: Anti-Trust, Covidien, European Commission, Medtronic buys Covidien

Medtronic reveals leadership team after mega-merger with Covidien | The week in medtech M&A

October 15, 2014 By MassDevice Leave a Comment

Medtronic announces leadership roster for post-Covidien merger

October 10, 2014 by Brad Perriello

Filed Under: Mergers & Acquisitions, News Well Tagged With: Advanced Biologics, Allergan, Bioventus LLC, Covidien, European Commission, Smith & Nephew, Steris Corp., Synergy Health, Valeant Pharmaceuticals

EuroZone anti-trust regulators to rule next month on $43B Covidien buy

October 14, 2014 By Brad Perriello Leave a Comment

EuroZone anti-trust regulators to rule next month on $43B Covidien buy

Filed Under: Mergers & Acquisitions, News Well Tagged With: Anti-Trust, Covidien, European Commission, Medtronic buys Covidien

Medical device makers find new layer of regulation before earning CE Mark approval | Regulatory news for the week of August 4, 2014

August 5, 2014 By MassDevice Leave a Comment

Medical device makers face new obstacles to European approval

July 30, 2014 by Arezu Sarvestani

Medical device makers face new obstacles to CE Mark

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Cohera Medical Inc., EDAP TMS SA, European Commission

Medical device makers face new obstacles to European approval

July 30, 2014 By Arezu Sarvestani Leave a Comment

Medical device makers face new obstacles to CE Mark

Medical device makers looking to bring new products to the European market will find a new layer of regulation before they can attain CE Mark approval.

The European Commission’s new hazardous substances restrictions now apply to medical devices for the 1st time, requiring that all products coming to the E.U. market after July 22, 2014, meet materials standards before they get market approval.

Filed Under: News Well, Regulatory/Compliance Tagged With: European Commission

European regulators issue guidance on nanotechnology in medical devices

July 28, 2014 By MassDevice Leave a Comment

European regulators issue guidance on nanotechnology in medical devices

By Stewart Eisenhart, Emergo Group

The European Commission has published new guidance on how manufacturers, regulators and Notified Bodies should assess potential risks posed by nanotechnologies used in an increasing number of medical devices.

Filed Under: Blog, News Well, Regulatory/Compliance Tagged With: Emergo Group, European Commission, Regulatory

FDA wants another advisory panel hearing for BSX Watchman anti-stroke device | Regulatory news for the week of June 23, 2014

June 24, 2014 By MassDevice Leave a Comment

FDA wants another panel hearing on Boston Scientific's Watchman anti-stroke device

June 17, 2014 by Brad Perriello

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Boston Scientific, C.R. Bard, Emergo Group, European Commission, Johnson and Johnson, Medicines & Healthcare products Regulatory Agency (MHRA)

Scotland curbs use of transvaginal mesh amid global outcry

June 19, 2014 By Arezu Sarvestani Leave a Comment

Scottish regulators curb use of women's surgical mesh amid growing controversy

Scottish health regulators are looking to curb use of transvaginal mesh products while independent investigators look into claims that the medical implants hurt women.

Filed Under: Gynecological, Implants, News Well, Regulatory/Compliance, Women's Health Tagged With: Boston Scientific, C.R. Bard, European Commission, Johnson and Johnson, Medicines & Healthcare products Regulatory Agency (MHRA), Pelvic Mesh Lawsuits

Medtronic acquires Covidien in a $43 billion deal | Medtech Wall Street news for the week of June 16, 2014

June 19, 2014 By MassDevice Leave a Comment

Blockbuster: Medtronic in $43B deal to acquire Covidien

June 16, 2014 by Brad Perriello

Blockbuster: Medtronic in $43B deal to acquire Covidien

Filed Under: Food & Drug Administration (FDA), News Well, Wall Street Beat Tagged With: Allergan, Biomet, Boston Scientific, Covidien, European Commission, Pershing Square Capital Management, Valeant Pharmaceuticals, Zimmer Biomet

European Commission tables review of Zimmer’s $13B acquisition of Biomet

June 13, 2014 By Brad Perriello Leave a Comment

European Commission tables review of Zimmer's $13B acquisition of Biomet

The European Commission tabled its review of the pending, $13.35 billion merger between Zimmer (NYSE:ZMH) and Biomet, saying Zimmer’s submission for the June 3 review was insufficient.

Filed Under: Mergers & Acquisitions, News Well, Orthopedics, Wall Street Beat Tagged With: Biomet, European Commission, Zimmer Biomet

Judge cuts Biolase board of directors | Medtech legal news for the week of Mar. 31, 2014

March 31, 2014 By MassDevice staff Leave a Comment

UPDATE: Court cuts Biolase board, marketing VP under fire

March 24, 2014 by Arezu Sarvestani

Court halves Biolase board, marketing VP under fire

Filed Under: Legal News, News Well Tagged With: Alliant Enterprises, Biolase, Corporate Action Network, Ethicon, European Commission, European Union, Intuitive Surgical, Johnson and Johnson, Legal Roundup, Millennium Dental Technologies, Oracle Partners, Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Stryker, U.S. Justice Dept. (DOJ)

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