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Breast Implant Litigation - The Defense Wins a Couple
  • Reed Smith LLP
  • USA
  • January 21 2019

Wait a minute, you might be saying, breast implant litigation? Isn't that passé? I n a sense, we'd agree with you. This isn't your father's


Boston Scientific Exercises Option to Acquire Transcatheter Annuloplasty Ring Developer Millipede Inc.
  • Knobbe Martens
  • USA
  • January 20 2019

Global medical device company Boston Scientific has announced on December 27, 2018, that it exercised its option to acquire remaining shares of


Medical Research Organization NAMSA Announces Acquisition of Reimbursement Strategies Consultancy
  • Knobbe Martens
  • USA
  • January 19 2019

NAMSA, which describes itself as “the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated


Digital health: software as a medical device
  • Corrs Chambers Westgarth
  • USA
  • January 18 2019

With huge technological advances being made in the delivery of health products and services, it is crucial to keep an eye on any regulatory movement


FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices
  • Epstein Becker Green
  • USA
  • January 16 2019

On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the


HHS Releases Voluntary Cybersecurity Practices, Supplementing Existing Requirements
  • Burns & Levinson LLP
  • USA
  • January 15 2019

At the close of 2018, the Department of Health and Human Services (HHS) published Health Industry Cybersecurity Practices (HICP): Managing Threats


Turkey Aligns its Medical Device Regulation with the EU Regulation
  • ELIG Gürkaynak Attorneys-at-Law
  • Turkey, European Union
  • January 15 2019

In May 2017, Regulation (EU) 2017745 of the European Parliament and of the Council of 5 April 2017 on medical devices ("EU Regulation") entered into


FDA’s New Year Resolution: Breakthrough Barriers and STeP Up Device Innovation
  • Epstein Becker Green
  • USA
  • January 10 2019

On December 18, 2018 the Food and Drug Administration (“FDA”) finalized guidance on its existing Breakthrough Device Program and announced plans for


CJEU rules on 'tender shaping' practices in the medical device sector
  • Loyens & Loeff
  • European Union
  • January 10 2019

On 25 October 2018, the CJEU ruled in Case C-41317 on the margin of discretion of contracting authorities to establish technical specifications in


Life Sciences Bit: CJEU rules on "Tender shaping" practices in the medical device sector
  • Loyens & Loeff
  • European Union
  • January 9 2019

On 25 October 2018, the CJEU ruled in Case C-41317 on the margin of discretion of contracting authorities to establish