FDA clears Bendit’s steerable vascular microcatheter
Israel-based Bendit Technologies’ steerable microcatheter has gained clearance from the US Food and Drug Administration (FDA), providing US clinicians with …
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Subsense secures $10m to advance BCI R&D efforts
US-based Subsense has raised $10m, bringing the brain-computer interface (BCI) developer’s total funding to $27m since it emerged from stealth …
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Vesalio secures FDA clearance for enVast clot retriever
The Food and Drug Administration (FDA) has granted 510(k) clearance for Vesalio’s enVast clot retriever, paving the way for its …
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Guardant Health and Trial Library to expand access to US cancer trials
Guardant Health and AI technology firm Trial Library have formed a strategic partnership aimed at improving access to cancer clinical …
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FDA clears Flow Neuroscience’s at-home depression treatment in US first
The US Food and Drug Administration (FDA) has cleared Flow Neuroscience’s at-home, non-drug depression treatment, making it the first device …
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FDA greenlights Lumos Labs’ digital ADHD therapeutic
Lumos Labs has gained US Food and Drug Administration (FDA) clearance for LumosityRx, a prescription digital therapeutic (PDT) that aims …
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Impulse Dynamics raises $158m to advance clinical and technology pipelines
Impulse Dynamics has secured over $158m in funding aimed at supporting its commercialisation efforts and progressing its clinical and technology …
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First patient treated in Nitinotes’ trial of EndoZip system for ESG
Nitinotes has commenced its US investigational device exemption (IDE) Endoscopic Automated Sleeve Evaluation (EASE) clinical trial, with the first patient …
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Medical Device Network Excellence Awards 2025: Penumbra
Penumbra’s launch of the Ruby® XL peripheral embolization coil system won the Innovation award in the Vascular Solutions category and …
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FDA clears HeartBeam’s at-home arrhythmia assessment tool
HeartBeam has secured US Food and Drug Administration (FDA) clearance for its 12-lead electrocardiogram (ECG) synthesis software, setting the arrhythmia …
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Teleflex to sell trio of business lines in deals totalling over $2bn
Teleflex is selling its acute care, interventional urology, and original equipment manufacturer (OEM) businesses in two separate deals totalling over …
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Pulse Biosciences and MD Anderson to study nPulse for thyroid cancer
Pulse Biosciences has entered a research partnership with The University of Texas MD Anderson Cancer Center, US, to investigate the …
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Roche gains CE Mark for bacterial vaginosis/candida vaginitis assay
Roche has secured CE Mark approval for its cobas bacterial vaginosis/candida vaginitis (BV/CV) assay to support the diagnosis of infectious …
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Agentic AI in healthcare holds opportunity for European players to arise
Europe currently has a strong opportunity to become a key global player in agentic artificial intelligence (agentic AI) and its …
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Medline seeks $5.37bn in largest healthcare IPO of 2025
Medline has filed for an initial public offering (IPO) seeking to raise up to $5.37bn, a figure that would leave …
