The National Law Review1h
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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medtechdive5h
Former FDA head Gottlieb calls for less regulation of certain AI tools
Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st Century Cures Act.
FierceBiotech1d
FDA amplifies BD atherectomy safety alert following 4 deaths
The FDA is getting the word out on a high-risk issue related to artery-clearing catheters from BD’s Bard Peripheral Vascular ...
medtechdive5d
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 ...
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.
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FDA grants 510(k) clearance to GE HealthCare’s updated ultrasound systems
"FDA grants 510(k) clearance to GE HealthCare’s updated ultrasound systems" was originally created and published by Medical ...
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 ...