Neuralink brain chip implant trials get FDA approval
Elon Musk’s brain chip interface company Neuralink announced that it has received FDA approval to begin conducting human trials.
Browsing Tag
FDA
Blockchain May Be Used in FDA Medical Reviews and Recalls
The Food and Drug Administration (FDA) may incorporate blockchain to improve drug and medical products reviews and recalls. In a speech at the Office of the…
FDA issues new draft guidance and more digital health news briefs
FDA draft guidance on BCI devices. The FDA signaled its interest in the development of implanted brain-computer interface (BCI) devices on Friday with the…
The New AI: Why The FDA Is Not Enough
The odds are good that radiologists want to believe in artificial intelligence (AI). The hype from vendors, professional societies and the media has been…
The FDA surprised Silicon Valley e-cig startup | Digital Asia
Digital Asia News Update
In a surprise visit, representatives from the Food and Drug Administration showed up at the headquarters of Silicon Valley…
The Bleeding Edge shows why FDA regulation needs to change | Innovation
Reece Armstrong looks into Netflix’s latest documentary, The Bleeding Edge and examines the FDA’s regulatory approvals for medical devices and why it needs to…
FDA to use ISO 13485 for medical device quality | Innovation
To help streamline regulatory processes for medical devices across the world, the FDA has decided to replace its current system with ISO 13485, the…
FDA clears Baxter’s prepackaged synthetic bone filler graft | Digital…
Baxter International received an FDA clearance for a new formulation of its Actifuse synthetic bone graft substitute, now deliverable via a prepackaged syringe…
FDA starts pilot to help sponsors use novel trial designs | Digital Science
The FDA has initiated a pilot program (PDF) to help drug developers use complex innovative trial designs (CID). Sponsors accepted into the four-year pilot will…
FDA warns Zimmer Biomet about Indiana manufacturing site | Digital Science
Zimmer Biomet received a warning letter from the FDA about quality violations found at a plant in Warsaw, Indiana. The agency had flagged the issues after a…