The CDRH notes that the goal of the guidance is to put safe and effective advancements in the hands of healthcare providers and users more quickly to help increase the pace of medical device innovation in the U.S. and enable more personalized medicine.
New data presented at the Technology and Heart Failure Therapeutics (THT) Conference showed that hemodynamic monitoring can slow the progression of heart failure in patients with reduced ejection fraction.
The final guidance includes recommendations for various elements of animal studies, including the credentials for personnel conducting an animal study, and the study planning and conduct process, including selecting an appropriate animal model, study monitoring, and study evaluation.
“I am honored to welcome Thierry Bernard as the new chair of the AdvaMedDx Board. With his decades of experience, Thierry brings a clear vision of the work we can accomplish, and I look forward to working with him.”
On Monday, March 20, the EU MDR extension approved on March 7 came into effect following its official publication in the Journal of the European Union.
On May 16-17, device developers, regulatory affairs and regulatory intelligence professionals will come together in Washington, DC, for two days of education, discussion and networking to share strategies and best practices on navigating current and on the horizon regulatory requirements.
Unhappy with current textbooks and resources for regulatory professionals, Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston Scientific, authored his own book for industry and future regulators.
Hägen, who was a contributor to Medtech Intelligence, spent 28 years building BlackHägen Design to support clients in the development of “mission-critical” products. He was pivotal in the advocacy of human factors and good design practices for medical devices and was at the forefront of patient safety initiatives, helping to found the Industrial Designers Society of America (IDSA) Patient Safety Committee.
A new guide from the Healthcare and Public Health Sector Coordinating Council recommends cybersecurity strategies that manufacturers and health providers can implement for legacy medical technology as a shared responsibility in the clinical environment, and provides insights for designing future devices that are more secure.
The Gushu facility in Shenzhen, China, achieved the accreditation after meeting the rigorous audit requirements set by MedAccred subscribing members, including Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics and Stryker.
