Unpack the complexities of Section 524B, a key legislative directive aimed at fortifying cybersecurity measures within the ...
This week, FDA issued a safety communication connected to Zimmer Biomet’s CPT Hip System Femoral Stem after finding increased risk of thigh bone fracture — postoperative periprosthetic femoral ...
Examining the evolving dynamics between EU and FDA regulations for medical devices. The webinar will address the historical practice of obtaining a CE Mark in Europe first, contrasting it with the ...
The increasing use of technology in medicine has created cybersecurity vulnerabilities that threaten healthcare systems and patient outcomes. Medical devices are particularly susceptible to attacks ...
As medical technology becomes more sophisticated and interconnected, device security threats escalate to pose risks in patient health and privacy. The U.S. FDA has strengthened its cybersecurity ...
Duane Morris Silicon Valley office partner Agatha H. Liu, PhD, practices intellectual property law, focusing on IP analysis, portfolio management, and strategic counseling. Drawing on more than 20 ...
Fluid connectors that “talk,” or exchange data with each other can provide an elegantly simple solution for enhancing instrument function, tracking IVD consumable media, and preventing operator errors ...
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A camera-carrying pill may soon be available as a painless alternative to invasive gastrointestinal endoscopy. The disposable capsule, which will be marketed by Given Imaging Ltd. (Yokneam, Israel), ...
For nearly 10 years, Technical Committee 194 of the International Organization for Standardization (ISO) and its various working groups have been developing the documents known collectively as ISO ...