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eHealth - the new way to treat mental health?

About the author: Aline Noizet is a connector by heart. Founder of Digital Health Connector, she is passionate about digital health, innovation and connecting the right people to have an impact on...

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Roundup: CardieX files 510(k) for dual blood pressure, arterial health...

CardieX files 510(k) for dual blood pressure, arterial health monitorAustralia-listed health tech firm CardieX has filed a 510(k) premarket submission with the US Food and Drug Administration for its...

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ResApp gets 510(k) clearance for mobile sleep apnoea test SleepCheck

ASX-listed ResApp Health has received the US Food and Drug Administration's 510(k) clearance for SleepCheckRx, its mobile sleep apnoea screening app. Introduced two years ago, SleepCheck is an at-home...

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Thailand OKs South Korean startup JLK's AI brain image analysis solution

Medical AI company JLK from South Korea has received medical device approval from Food and Drug Administration Thailand for its AI brain image analysis solution.Founded in 2014, the startup offers a...

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Ceribell raises $50M for seizure monitoring and detection technology

Led by Ally Bridge Group and with the help of its existing shareholders, venture-backed Ceribell, Inc. has raised $50 million.The funding was structured as an extension of its $53 million Series C...

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Aetion, FDA partner on oncology real-world data

Aetion, a startup focusing on real-world evidence in healthcare, announced a five-year research collaboration with the FDA's Oncology Center of Excellence (OCE). The OCE will use Aetion's Evidence...

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FDA releases updated final guidance for its Breakthrough Devices Program

On Thursday, the FDA Center for Devices and Radiological Health released updated final guidance for its Breakthrough Devices Program, aimed at verifying medical devices on the market are safe and...

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Lunit receives $150M capital chip-in, doubles down on US market

Shareholders of KOSDAQ-listed Lunit have recently participated in the company's recent capital raise, paying-in $150 million to fund its development of "next-generation" products and further expansion...

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