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.
JD Supra3 天
FDA to Study Presence of Metals in Tampons: What to Know
Biocompatibility and Toxicology Program published a statement announcing its intention to commission an independent literature review and internal bench laboratory study to evaluate the presence of ...
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 ...
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 ...
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 ...
MedPage Today13 天
Are Regulators the Root of the Problem of Serious Device Recalls?
Short follow-up is another problem that often appears in the backstory of recalled cardiovascular devices, such as the ...
News Letter on MSN11 个月
Belfast firm receives 'landmark step' with FDA clearance for medical device to treat insomnia
Neurovalens, a global leader in non-invasive neuro-technology, gets medical device clearance from the US Food & Drug ...
Fortune11 天
The 6 best pulse oximeters, reviewed by medical experts
These small devices often clip onto your finger and use different wavelengths of light to determine how much oxygen is being carried in the blood, also called oxygen saturation (SpO2). ( 2 ) Pulse ...
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 ...
health.economictimes.indiatimes10 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 ...
GlobalData on MSN10 天
FDA lists Astellas’ digital health solution for heart failure management
The US Food and Drug Administration (FDA) has listed Astellas Pharma’s non-invasive digital health solution, DIGITIVA, ...