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Results: 1-10 of 2,395

Capitol Hill Healthcare Update
  • Baker & Hostetler LLP
  • USA
  • April 9 2018

Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised to examine the opioid


Hospitals Face Sizable Overpayment Liability for Not Reporting Medical Device Credits
  • Nelson Mullins Riley & Scarborough LLP
  • USA
  • April 9 2018

The Office of Inspector General (OIG) continues to unearth widespread noncompliance by hospitals with requirements for reporting the receipt of


Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar
  • Skadden Arps Slate Meagher & Flom LLP
  • USA
  • March 29 2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused


Connected medical device vulnerabilities continue to impact manufacturers, health care
  • Thompson Coburn LLP
  • USA
  • March 22 2018

Recently, Thompson Coburn’s Life Sciences Decoded blog described several FDA initiatives to increase the safety and reliability of the emerging


Minnesota Court Excludes Plaintiff Expert Opinions For Lack of General Acceptance
  • Reed Smith LLP
  • USA
  • March 21 2018

All of us - defense lawyers, plaintiff lawyers, and judges - tend to assume that the federal Daubert standard for admissibility of expert testimony is


Third Circuit Grants Express Preemption in “Hybrid” Medical Device Case
  • Bradley Arant Boult Cummings LLP
  • USA
  • March 6 2018

On March 1, the U.S. Court of Appeals for the Third Circuit, in Shuker et al. V. Smith & Nephew PLC, affirmed a District Court’s ruling that claims


FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical Devices
  • Morgan Lewis & Bockius LLP
  • USA
  • February 27 2018

The US Food and Drug Administration's new requirements for sponsors to follow Good Clinical Practices (GCPs) for ex-US device clinical trials will


What is software as a medical device?
  • Dentons
  • USA
  • February 23 2018

The US Food and Drug Administration (FDA) is considering changes to the regulatory pathways for software used as a medical device (SaMD). Members of


Top 7 Legal Challenges Facing Physicians and Hospitals
  • Jackson Lewis PC
  • USA
  • February 21 2018

The American Health Lawyers Association’s 2018 Physicians and Hospitals Law Institute in New Orleans focused on the legal challenges faced by


MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review
  • Knobbe Martens
  • USA, Israel
  • February 18 2018

Tel Aviv-based MedyMatch Technology recently announced it has received Expedited Access Pathway (EAP) designation from the FDA for its intracranial