Hosted on MSN3h
FDA grants breakthrough designation for Acrivon’s endometrial cancer assay
The US Food and Drug Administration (FDA) has granted breakthrough device designation for Acrivon Therapeutics’ ACR-368 ...
dvm3601h
FDA notifies veterinarians of animal burn risk linked to human medical devices
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
Medscape10h
FDA Warns About Diabetes Device Smartphone Alert Settings
The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood ...
Hosted on MSN57m
Newronika secures FDA’s IDE to begin adaptive deep brain stimulation system trial
The trial will assess the efficacy and safety of the system in individuals with movement disorders such as Parkinson's disease.
JD Supra3d
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 ...
MedPage Today2h
FDA Warns of Possible Missed Phone Alerts From Diabetes Device Apps
Some patients with diabetes may be missing critical safety alerts on their phones, the FDA warned on Wednesday.
STAT13d
FDA purges material on clinical trial diversity from its site, showing stakes of Trump DEI ban
Following the Trump administration's DEI ban, the FDA's move to scrub webpages has ensnared many pages focused on ensuring ...
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.
The Taipei Times4d
‘Medical devices’ cannot be resold, the FDA says
Some products bought in pharmacies, including tampons and adhesive bandages, are listed as “medical devices” in Taiwan and ...
Monthly Prescribing Reference1d
FDA: Diabetes Device Alerts May Be Missed Due to Smartphone Settings
Health care providers are urged to inform patients to periodically check their smartphone settings and to confirm that they are able to receive alerts.
medtechdive21h
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 ...
medtechdive6d
FDA warns about patient monitor cybersecurity vulnerabilities
Vulnerabilities in certain Contec and Epsimed patient monitors can allow people to gain access and potentially manipulate the ...