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...
View ArticleRoundup: 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...
View ArticleResApp 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...
View ArticleThailand 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...
View ArticleCeribell 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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View ArticleAetion, 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...
View ArticleFDA 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...
View ArticleLunit 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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