fda clearance

Gadgets

Has ‘Wellness’ Lost Its Meaning in Health Tech?

The regulatory landscape for health wearables is unclear, creating tension between fast innovation and consumer safety as devices blur the…

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AI & Tech

FDA Clears AI-Powered Fetal Ultrasound by Biotics AI

The FDA has cleared an AI software from Biotics AI that analyzes prenatal ultrasounds to help detect fetal abnormalities, improve…

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Gadgets

L’Oréal’s New LED Face Mask Solves Common Skincare Problems

L'Oréal's upcoming LED face mask prioritizes a lightweight, flexible design for comfort and better light penetration, with brief 5-10 minute…

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Gadgets

From Taint Bandaid to Taint Zapper: The Evolution of Anal Care

The Mor device evolved from a crude prototype into an FDA-cleared medical product for male sexual health, specifically addressing premature…

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Business

Navigating Regulation to Build Venture-Backable Companies

Launching a startup in a regulated industry requires immense patience, capital, and strategic foresight to navigate complex government agencies and…

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Gadgets

Oura’s New App Redesign and Cumulative Stress Feature

Oura's app update introduces a new design with personalized tabs for daily insights, vitals, and long-term health management, including features…

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BigTech Companies

Apple Watch Hypertension Alerts Get FDA Clearance for All Models

Apple has received FDA clearance for a hypertension notification feature on compatible Apple Watch models, enhancing proactive cardiovascular monitoring for…

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