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Medical Devices & Diagnostics

Medical Devices & Diagnostics

Is Bebird’s EarSight Ultra X a glimpse into the future of consumer-grade otoscopy?

Bebird, the consumer-focused smart health technology firm, has officially launched the EarSight Ultra X, a next-generation ear care device featuring real-time 5G connectivity, 4K endoscopy imaging, and multiple safety enhancements tailored for family use. Positioned as a proactive wellness solution rather than a regulated diagnostic tool, the product aims to bring clinical-grade visualization into home

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Medical Devices & Diagnostics

BrainSpace wins FDA nod for automated brain fluid system—what this means for ICUs

BrainSpace, a U.S.-based medical technology company, has received 510(k) clearance from the U.S. Food and Drug Administration for Intellidrop, a fully automated cerebrospinal fluid (CSF) drainage and intracranial pressure (ICP) monitoring system. The cleared indication covers ventricular or lumbar use in patients requiring external CSF drainage and continuous pressure monitoring—making it potentially relevant across a

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Medical Devices & Diagnostics

Can Positron Corporation’s $2m raise unlock growth in cardiac PET-CT imaging?

Positron Corporation raises $2 million to fund PET-CT system expansion in cardiac and oncology imaging. Can it scale fast enough to compete?

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Medical Devices & Diagnostics

Intelligent Bio Solutions taps Syrma Johari to cut drug reader costs and prep for U.S. launch

INBS teams up with Syrma Johari to cut device costs, expand global output, and prep for a 2026 U.S. launch. Find out what this changes for fingerprint drug testing.

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Medical Devices & Diagnostics

Fulgent Genetics acquires Bako Diagnostics and StrataDx to expand AI pathology strategy

Fulgent Genetics acquires Bako Diagnostics and StrataDx to scale AI pathology, expand national reach, and advance precision medicine strategy. Read full analysis.

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Medical Devices & Diagnostics

Edwards Lifesciences’ SAPIEN M3 FDA approval marks a turning point for transseptal mitral valve therapy

Edwards Lifesciences’ SAPIEN M3 becomes the first FDA-approved transseptal mitral valve replacement system. Explore how it reshapes TMVR in 2026.

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Medical Devices & Diagnostics

Can Cataltheia’s Deseyne lens replace multifocal optics in age-related vision correction?

FDA clears Deseyne, the first EDOF contact lens for presbyopia. Find out how it could reshape non-surgical vision correction in the U.S. market.

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Medical Devices & Diagnostics

Can Establishment Labs shift the breast reconstruction standard in the U.S. with Motiva?

Find out how Establishment Labs is aiming to transform U.S. breast reconstruction with Motiva implants and FDA approval. Read what changes and risks lie ahead.

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Medical Devices & Diagnostics

Can PathoCare’s $1.75bn tender offer reprice the future of AI-driven diagnostics?

Find out why PathoCare's $1.75B valuation and expanded $50M financing round could signal a breakthrough moment for AI-powered point-of-care diagnostics.

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Medical Devices & Diagnostics

Vicarious Surgical bets on outsourced software execution to control costs and advance clinical timelines

Vicarious Surgical shifts software development to a global partner to cut costs and hit clinical trial milestones. Here’s what this means for its platform.

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