Vulnerabilities in certain Contec and Epsimed patient monitors can allow people to gain access and potentially manipulate the ...
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...
On Dec. 23, Avita received FDA approval for a version of the Recell device that treats small-scale wounds. According to the ...
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Merit Medical Celebrates FDA Approval of WRAPSODY™An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...
The FDA has granted 510(k) clearance to a Bay Area commercial stage medical technology company for its novel large-bore ...
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...
MNT spoke with Eric C. Alcera, MD, chief medical officer and vice president at Hackensack Meridian Health at Carrier Behavioral Health in New Jersey, about this recent FDA approval. “This is a ...
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to raise awareness about cybersecurity vulnerabilities in Contec CMS8000 patient monitors and Epsimed MN-120 patient ...
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate ...
Medtech company DermaSensor has claimed FDA approval for a handheld device, powered by artificial intelligence (AI), that can be used to detect skin cancer at the point of care. The eponymous ...
This ensures transparency and contributes to medical knowledge. Future guidance and resources include: Clinical Trial Reporting and Data Sharing. Study close-out marks the final step of a clinical ...
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