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.
On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of ...
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 ...
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 ...
What is driving the need for increased transparency across the MedTech organization relative to product innovation, ...
CE Marked and 510(k) pending, Philips says Rembra’s advanced image reconstruction technology delivers up to 106 images per second and a high throughput of up to 270 patients per day [2] to support ...
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 ...
Cloud-based SaMD (Software as a Medical Device) designed to assist healthcare providers in predicting delivery date using ultrasound imaging ...
According to a company press release, RadNet, Inc. has acquired Gleamer SAS, a leading radiology AI company based in Paris, France. The acquisition will be integrated into DeepHealth, RadNet’s wholly ...
Quantum Surgical and NeuWave Medical, Inc. – both of which share an extensive focus on innovation to improve cancer patients’ outcomes – will operate as subsidiaries of Precision IO Group Inc., the ...
A comprehensive update on the combination products market shows significant industry partnerships, development challenges, and strategic imperatives for success in the sector characterized by dynamic ...
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