Mindray says its entry into the ventilator market marks a significant step in expanding advanced respiratory care options for ...

Hypoglossal nerve stimulation therapy approved in the U.S. without complete concentric collapse contraindication or warning ...

The medical device industry and EPA have been in ongoing debate over balancing the need for sterile medical equipment with concerns about pollution near sterilization plants.

Perfuze states the Millipede88 is the first 088 aspiration catheter with patented corrugated technology cleared for standalone direct aspiration — no large-bore intermediary required — backed by ...

With its FDA approval, JenaValve intends to commence launch activity for the Trilogy System immediately with participating ...

The Urocross Expander System is designed to remodel the obstructing prostatic lobes during the six-month indwell time and is intentionally retrieved, leaving no permanent foreign material behind.

To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, and interfaces and communication protocols need to be established across ...

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. This dynamic which scrutinized ...

FDA final guidance titled Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.

According to multiple news agencies worldwide, a pro-Iranian cyber group, Handala, has claimed responsibility for a cyber attack on medical device giant, Stryker. The attack resulted with thousands of ...

The FDA launched The Adverse Event Monitoring System (AEMS), calling it a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.