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How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
2025 Medical Device Cybersecurity Trends: What Will Shape The Industry?
What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.
Medical Design and Outsourcing10d
FDA’s Tarver pushes for mandatory medical device shortage reporting
The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...
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Korea designates 29 innovative medical devices, prioritizes GMP review for 2025
we will actively support the rapid market entry of innovative medical devices utilizing advanced technologies, including applying priority reviews under GMP (Good Manufacturing Practice ...
Neuralink’s ‘breakthrough device’ clearance from FDA does not mean they have cured blindness
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.
Healio26d
FDA grants priority review to oral non-small cell lung cancer drug
“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 ...
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FDA delays priority review of Neurotech’s eye cell therapy implant
Neurotech Pharmaceuticals’ eye cell therapy implant has faced a setback as the US Food and Drug Administration (FDA) has ...