The U.S. owns the lead in the critical categories of scientific quality and commercial know-how. However, Chinese development is faster, bigger and cheaper—and gaining on us. Which nation will ultimately prevail?
An alleged whistleblower working for Abbott, Kris Ghosh, claims to have evidence of Pacific Vascular Institute utilizing more products for atherectomy procedures than medically necessary.
Mercy Health-Lorain Hospital is suing the county after police revoked protection services for the Catholic facility, which refused to remove the baggie, citing safety concerns.
Some FDA-approved medical devices age more safely than others. That’s no less true of AI-enabled technologies than of any others. The agency spells out the ramifications in draft guidance issued this week.
The devices struggle to accurately read blood-oxygen levels in patients with darker and thicker skin. The FDA hopes that changes in design and improved clinical trials will improve clinical efficacy.
