The National Law Review6h
CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices
Contec Medical Systems (“Contec”), a global medical device and healthcare solutions company headquartered in China, sells ...
FDA tags Sentec/Percussionaire’s breathing circuit recall as Class I
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medtechdive6d
FDA labels recall of discontinued Olympus endoscope part as Class I
The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of ...
Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer
The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, ...
Acrivon Therapeutics Gets FDA Breakthrough Device Designation for Cancer Identification
Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...
JD Supra8d
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 ...
Obesity-drug maker Metsera posts largest gain as IPOs defy market swoon
Obesity-drug maker Metsera Inc.'s stock jumped 47% on Friday as the biggest gainer among three initial public offerings bucking a swoon in the equity market to rise in their stock-market debuts Friday ...
FDA approved the first new kind of pain medication in 27 years. Here’s how it works
The FDA just approved a new type of pain medication, and it's a non-opioid called suzetrigine that stops body pain at its ...
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.
CNN20d
FDA approves standalone use of J&J’s ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression ...
Medical Design and Outsourcing21d
Cortland Biomedical secures FDA registration
“This milestone underscores our dedication to maintaining world-class quality systems ... forward-integrated approach to medical device development. For more information about Cortland Biomedical and ...