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    FDA clears XO Cross microcatheters

    Transit Scientific this week announced that it has received FDA clearance for its hydrophilic-coated XO Cross microcatheters for guidewire support, exchange and contrast media...

    Vuno’s AI-based ECG analysis software gains breakthrough designation

    South Korean artificial intelligence (AI) developer Vuno has announced that the Korean Ministry of Food and Drug Safety (KFDA) has designated the company’s AI-based...

    FDA grants breakthrough designation to Magnus’ neurostimulation technology

    In a randomised trial, the neurostimulation technology relieved severe depression in 79% of people. The US Food and Drug Administration (FDA) has granted Breakthrough Device...

    FDA outlines best practices for healthcare AI, alongside Canada, U.K. regulators

    The FDA is joining hands with fellow regulators in Canada and the U.K. to present 10 principles outlining best practices in the development of...

    Cheek swab COVID-19 test receives CE mark

    Intelligent Fingerprinting’s saliva-based COVID-19 test now carries CE marking. The new VSS-GP COVID-19 Saliva Test uses a swab to collect saliva from just inside the cheek, providing...

    Trice Medical nabs first FDA go-ahead for disposable arthroscope with 25-degree view

    Though disposable needle arthroscopes have become increasingly popular due to their lower risk of contamination and less invasive profile, full-size reusable arthroscopes are still the...

    AI-powered ‘Test-To-Go’ system receives CE mark

    Clinical AI company Sensyne Health’s licence and development partner, Excalibur Healthcare Services, has received European regulatory certification, which includes the UK, for its ‘Test-To-Go’ COVID-19...

    Luminopia scores FDA De Novo for VR treatment for lazy eye

    The tool uses virtual reality to modify media content in order to help children boost their visual acuity. Massachusetts-based Luminopia landed an FDA De Novo...

    Kerecis Announces First-Ever Fish-Skin Implantable Medical Product for Surgery

    Fish graft used in human plastic and reconstructive surgery to reinforce soft tissue Kerecis®, the company pioneering the use of fish skin and fatty acids...

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