The goal of the voluntary program is to streamline the submission process. The agency also announced that it has selected participants for its EtO Innovation Challenges.
The report also found that medical device companies are taking “huge gambles” in the area of risk management.
For too long this industry has lagged the pharma sector in terms of using data analytics to predict market trends. It’s time to change that.
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.
Stakeholders warn that more EtO facility closures could have a catastrophic result.
The White House issued a statement on the president’s intent to nominate Hahn, who is currently the chief medical executive at The University of Texas MD Anderson Cancer Center in Houston.
The agency continues to monitor the safety of the grafts manufactured by Endologix, while the company defends its safety.
Six medical societies sent a letter to the agency over concern that limiting EtO sterilization will also limit the availability of certain devices to patients.
All of the issues that ECRI calls out on its list are preventable, so device manufacturers and healthcare providers should take serious note.
URGENT/11 introduces risks to medical device and hospital networks, and could allow a remote attacker to take control of a medical device such as an anesthesia machine of insulin pump.