Tagged medical device

Robotic Medical Device Recalled Due to Software Issue

A major medical device manufacturer has recalled a robotic medical surgical device due to software issues that could put patients’ lives at risk. Issued by the device manufacturer Zimmer Biomet in September,... Read More...

The EU’s Medical Device Regulation (EU) 2017/745 – Are You Ready for Huge Sweeping Changes?

This article discusses the history of why the EU MDR came into existence. It goes into the critical dates to be aware of, many of the significant changes, and impacts on many of the players (Notified Bodies, manufacturers, etc.). Lastly, it details the key steps that device manufacturers should take to implement the provisions of the MDR.

U.S. FDA Posts MDSAP Stakeholder Presentations

The U.S. Food and Drug Administration (FDA) has now provided access to presentations from the recent MDSAP Stakeholder Day, giving interested parties insight into the latest developments in the Medical Device S... Read More...

FDA Updates List of Recognized Standards

The FDA has published an updated list of recognized consensus standards that can used in support of premarket medical device reviews conducted by the agency.

FDA Publishes Final Guidance on Software as a Medical Device

The U.S. Food and Drug Administration (FDA) has issued a final version of its Guidance on the clinical evaluation of software as a medical device (SaMD). Published in early December, the Guidance adopts the ... Read More...

FDA Warns Medical Diagnostic Company of Violations

The U.S. Food and Drug Administration (FDA) has put a medical device manufacturer on notice for its failure to obtain proper approval for several versions of the company’s blood testing systems. According to... Read More...

Engineers Receive Grant to Further Develop an Implantable System that will Detect Lung Cancer

Scientists are hard at work on an implantable system that could help to detect lung cancer.

The EU’s MDR and IVDR Are Published!

The European Union’s (EU’s) new regulations applicable to medical devices and in vitro diagnostic devices have finally been published.

The EU’s MDR and IVDR Achieve Final Approval

The wait is nearly over for the official publication of the European Union’s (EU) new regulations applicable to medical devices and in vitro diagnostic devices. According to a posting on the website of the E... Read More...

EpiPens Recalled Due to Defective Part

Meridian Medical Technologies, the manufacturer of Mylan’s EpiPen-brand of epinephrine auto-injectors, has announced a voluntary recall of selected EpiPen lots due to safety concerns. According to the compan... Read More...

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