briefs

Roundup: Nesa gets US FDA 510(k) for fibroid mapping tool and more briefs

Nesa obtains US FDA 510(k) for fibroid mapping tech Indian femtech Nesa Medtech has received the United States Food and Drug Administration 510(k) clearance for its fibroid mapping tool. Its Fibroid Mapping Reviewer Application assists in the diagnosis and planning of interventional procedures for patients with uterine fibroids. It generates a 3D model of the …

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Roundup: South Korean AI software for sepsis detection gets US FDA nod and more briefs

SpassMed scores US FDA 510(k) for AI sepsis detection software South Korean medical AI company SpassMed has received the United States Food and Drug Administration’s 510(k) clearance for its AI-powered sepsis detection software.  The AI solution called SpassageQ has been approved as software as a medical device for identifying sepsis, anaphylaxis, and hypovolemic shock.  South Korean …

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Roundup: Dozee, SURGLASSES get 510(k) clearances and more briefs

Dozee scores 510(k) for AI contactless sensor for RPM Indian medical device company Dozee has received the United States Food and Drug Administration’s 510(k) clearance for its proprietary contactless sensor for remote patient monitoring. The Dozee sensor sheet, which is placed under a hospital bed mattress, captures micro-vibrations from patients using Ballistocardiography. These vibrations are then …

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