What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.
The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...
The designation also lines them up for priority FDA review. In 2023, more than 30 medical devices were given this same breakthrough designation, and almost 1,000 have been authorized total.
we will actively support the rapid market entry of innovative medical devices utilizing advanced technologies, including applying priority reviews under GMP (Good Manufacturing Practice ...
“Sunvozertinib’s priority review designation marks an important regulatory milestone in Dizal’s efforts to address unmet medical needs worldwide.” According to the release, sunvozertinib ...
Neurotech Pharmaceuticals’ eye cell therapy implant has faced a setback as the US Food and Drug Administration (FDA) has ...
Under revised standards, top priority would be ... of patients with the highest medical urgency currently include people fitted with a ventricular assist device. However, those categorized into ...