While half of all medical devices in the US are sterilized with ethylene oxide, emissions from the gas pose potential environmental hazards that are attracting federal action.
An infection from a medical device could result in a more serious condition than the one the device is meant to treat, which is why ensuring devices are thoroughly sterilized prior to use is essential for patient safety.
There are many methods to clean devices, such as radiation, steam, dry heat, and vaporized hydrogen peroxide, but the most...
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.
Without change, the implementation of the MDR and IVDR could hit another wall.
J&J’s global head of MedTech Digital envisions AI-powered connected operating suites within a decade. In an interview with Medtech Insight, Shan Jegatheeswaran discusses how J&J, together with partners like NVIDIA and AWS, is laying the foundation for open platforms for standardized surgeries.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
The US’ foreign trading partners are not working hard enough to secure bilateral deals, says US President Donald Trump, who will introduce new reciprocal tariffs on Aug. 7. MedTech Europe stresses that patients will suffer if medtech is not excluded from the tariffs.
Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.
