dermatologyadvisor5h
FDA Alert: Pulmonology Drug Approvals, Recalls, and Device Updates
FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.
JD Supra5d
510(k) RTA › FDA Approval › Medical Devices
It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found ...
Hosted on MSN2d
Merit Medical Celebrates FDA Approval of WRAPSODY™
An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...
Becker's Hospital Review9d
FDA's plan to tackle medical device shortages: 4 notes
To address these shortages, the FDA has put measures into place, including expedited review processes and the use of enforcement discretion. The FDA also now requires manufacturers to give at least ...
STAT29d
Save the Food and Drug Administration by breaking it up
The FDA is a top — maybe even the top — regulator in the world for approving new medicines. Trust in the FDA’s drug approval authority ... the-counter drugs, medical devices, diagnostics ...
Becker's Spine Review6d
Saluda Medical earns FDA approval for automated SCS platform
Saluda Medical earned FDA approval for its biomarker-based automated patient programming platform used in spinal cord stimulation.
PharmaTimes28d
FDA approves Sequana Medical’s Alfapump for ascites treatment
Sequana Medical NV has announced the US FDA approval of its Alfapump system for treating recurrent or refractory ascites due to liver cirrhosis. This approval marks Alfapump as the first active ...