medtechdive15h
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 ...
FDA labels recall of discontinued Olympus endoscope accessory 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 the device.
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.
JD Supra2d
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 ...
Pharmabiz29d
CDSCO seeks industry comment on updated classification list of four medical devices categories
The drug regulator has sought the industry to submit their comments ... as Class A comprising low risk devices, Class B for low moderate risk devices, Class C for moderate high risk products, and ...
Healio5d
FDA recalls Mercury Medical T-piece resuscitator due to ventilation control component
The FDA has recalled Mercury Medical’s Neo-Tee T-Piece Resuscitator, a gas powered resuscitator intended primarily for ...
Will These 5 Big Drug Stocks Surpass Q4 Earnings Forecasts?
Let's look at five pharma and drug companies, MRK PFE, LLY, AMGN and BMY, which are scheduled to release their fourth-quarter ...
FierceBiotech22d
FDA elevates Philips cardiac telemetry recall over unflagged ECG alerts, following 2 deaths
The FDA is elevating a recall from Philips related ... we proactively identified a software configuration issue and reported a medical device correction, offering clinicians the possibility ...
JD Supra23d
FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research
FDA Medical Device Regulation Over the Use of AI in ... indications that certain participants have a disease state; or (ii) a classification of the severity of participants’ disease state ...
MedPage Today9d
Limbo of Cardiac Device Recalls Has Physicians Ready for Change
A recent study identified 157 cardiovascular devices recalled from 2013 to 2022. Recalls were commonly attributed to device ...