medical-devices
5 stories tagged "medical-devices"
The FDA Is Building an On-Ramp for Medical AI That Can Hallucinate
The FDA has cleared more than 1,000 AI medical devices and not one large language model. Its new discussion paper starts building the pathway for the ones that can make things up, with faster delivery to market named as an agency priority.
Brain & AgingBerlin Physicists Bolted a Metamaterial to a 7-Tesla MRI, and the Living Eye Came Into Focus
It clips onto a 7-tesla scanner a hospital already owns, draws no extra power, and lifted the signal inside a living human eye by up to half.
Brain & AgingA 14-Patient Hand-Exoskeleton Study Lands in Science Advances, With a Headline That Outruns the Data
A Vienna-led team published a 14-patient feasibility study of a wearable hand exoskeleton with closed-loop electrical stimulation. The mechanism is genuinely novel; the headline is doing work the data cannot.
InvestigationsThe Hernia FAQ That Forgets to Mention the Implant
A polished hernia FAQ walks patients through recovery time, return-to-work, and lifestyle. It skips the question with 26,153 pending lawsuits behind it, and the no-mesh option the international guideline still keeps on the table.
Drugs & FDAAnother Clot Problem at Abiomed: The FDA Flags an Impella Introducer, and the Pattern Keeps Growing
FDA flags Abiomed's 14Fr Low Profile Introducer Kit after a higher than expected complaint rate of clots forming on the device during prolonged Impella CP support. Three serious injuries reported, no deaths. The pattern keeps growing.