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 ...
To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, ...
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 Revello™ Vascular Covered Stent is designed to combine the flexibility of a nitinol self-expanding stent with the radial ...
Abbott’s CardioMEMS™ HERO is a compact remote reader that is 60% lighter compared to its previous generation device for heart failure patients with Abbott’s CardioMEMS pulmonary artery pressure sensor ...
CE Marked and 510(k) pending, Philips says Rembra’s advanced image reconstruction technology delivers up to 106 images per ...
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.
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