With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...

Given that the FDA only mandates post-approval studies occasionally for medical devices approved through the PMA pathway, CMS plays an important role in incentivizing post-approval clinical ...

US FDA approves AVITA Medical’s RECELL GO mini disposable cartridge to treat smaller wounds: Valencia, California Friday, December 27, 2024, 18:00 Hrs [IST] AVITA Medical, Inc., ...

This week, the FDA issued recommendations for streamlining the clearance process for AI-powered medical devices ... Cardiovascular: The FDA has approved acoramidis (marketed by BridgeBio as ...

The US Food and Drug Administration (FDA) has approved Sequana Medical’s alfapump for the treatment of recurrent or ...

But with little financial incentive for companies to develop kid-specific treatments, pediatricians are often left to use adult medicines and medical devices off-label for their patients — or ...

The FDA has expanded the approval of Eli Lilly’s obesity medication Zepbound to include treating moderate to severe ...

Avita Medical has announced FDA approval for its new RECELL GO mini disposable cartridge. Spray-on skin The original RECELL platform received FDA approval in 2018 for severe burns ...

Signati™ Medical extends its deepest gratitude to the Principal Investigator, Dr. Matthew Mutter, whose expertise and dedication were instrumental in the success of this study. We also thank the ...

The TheraBionic P1 device is the first FDA-approved systemic therapy that utilizes radiofrequency ... Dr. Pasche is a respected medical oncologist who specializes in treating gastrointestinal cancers ...

Credit: Ionis Pharmaceuticals, Inc. The US Food and Drug Administration (FDA) has approved Ionis Pharmaceuticals‘ TRYNGOLZA (olezarsen), designed as an adjunct to diet for reducing triglyceride levels ...