The Food and Drug Administration recently published draft guidance for regulating med device data systems here FDA Draft Guidance, opening a 60 day comment period. Proposed is further…Continue
Tags: health, apps, medical, FDA
Started by Scott Olson in Uncategorized Jul 8.
FDA Nanotechnology GuidanceToday the FDA released three guidance documents on nanotechnology in regulated products. The document applicable to devices identifies two points to consider that…Continue
Tags: FDA, nanotechnology
Started by Scott Olson in Uncategorized Jun 24.
FDA proposed rule aims to simplify medical app classificationLast week a group of US Senators…Continue
Tags: public, comment, regs, FDA, apps
Started by Scott Olson in Uncategorized Mar 26.
Shark Tank investors liked the pitch but hated the $10 million valuation Dr. Amy Baxter put on her consumer medical device company.She appeared on the show asking for a $500,000 investment to scale her business, which…Continue
Started by Scott Olson in Sample Title Mar 3.
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