pulmonologyadvisor9 天
FDA Alert: Pulmonology Drug Approvals and Recalls, Medical Device Updates
FDA drug alerts in pulmonology, including drug approvals/warnings, vaccine approvals, medical device recalls/updates, and ...
FDA proposes reclassifying hepatitis B assays
The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.
Med Device Online4 天
Improving Medical Device Testing With Robotic Automation
Recent high-profile failures and recalls of medical devices highlight concerns about patient safety. Robotic automation in ...
dvm3606 天
FDA announces Smiths Medical ventilator recall
The FDA's Center for Veterinary Medicine (CVM) announced Smiths Medical’s recall of the PneuPAC paraPAC Plus P300 and PneuPAC ...
FDA designates Class I recall of McGrath Mac laryngoscopes
The seriousness of this latest recall can be expected to have a noticeable effect on Medtronic’s laryngoscope sales.
FierceBiotech6 天
FDA elevates 3 recalls of Smiths Medical ventilators, tracheostomy tubes
The FDA is elevating three sets of respiratory hardware recalls from Smiths Medical, covering portable ventilators and ...
pharmaphorum11 天
The booming medical device sector: How well are suppliers adapting to new regulatory demands?
Medical device companies are dealing with the impact of increasing regulations in a number of ways, including the ...
MassDevice5 天
FDA has a new top medical device evaluator
Segan has a long history in the medical device industry. Prior to joining the FDA, he was the managing director and founder of Medical Scientific Advisors. He has held numerous roles of varying ...
TCTMD13 天
Little Pre- and Postmarket Testing for Most Recalled CV Devices
The majority of FDA-recalled devices made it to market via the 510(k) pathway, which doesn’t require new clinical or safety ...
health.economictimes.indiatimes11 天
FDA recall orders for McGrath Mac’s Medtronic laryngoscope may hurt device sales: GlobalData
According to GlobalData, the decision of the US regulator is likely to hurt Medtronic's sales, which currently occupies ...