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 ...

In November 2023, B. Braun Medical initiated a correction of its Infusomat Space Large Volume Pump wireless, and Infusomat Space Large Volume Pump non-wireless battery pack after reports of faulty ...

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 ...

Unpack the complexities of Section 524B, a key legislative directive aimed at fortifying cybersecurity measures within the ...

The company said the cuts to its global workforce are a “one-size right-sizing of the organization”. Edwards Lifesciences said it will lay off 3% of its global workforce in a “one-time right-sizing of ...

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 ...

Fluid connector technologies are often a user’s primary interface with medtech products. They play an important role in successful fluid management — from providing reliable, leak-free performance to ...

The agency said it does not intend to authorize any medical device premarket submissions that use necessary data generated from these testing facilities.

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 ...