Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods.
The total $8.4 billion fiscal year 2023 budget request is 34% higher than the agency’s 2022 appropriated funding level.
The combination of medtech progress with strides in modern healthcare interoperability will enable preventive care in unprecedented ways.
New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
Some of the company’s V60 and V60 Plus ventilators were assembled with an expired adhesive, which could cause product failure.
2022 is now upon us, hopefully marking the end of a very disruptive couple of years. Global challenges, from supply chain shortages to remote services, have driven digital innovation and change in the way we work across all sectors. The medical device industry is no different and going forward, having learned from the experiences of 2021.
The findings suggest that manufacturers need to make user interface and user experience design improvements to certain wearable medical devices.
This year, the healthcare industry will step up its fight against cyberattacks because the costs and risks to patient care are becoming too great.
There is significant opportunity to develop therapies that create new standards of care and initiate a new wave of precision medicine.
Unauthorized access could allow an attacker to take full control of the host operating system.