May Health gains CE mark for infertility treatment
France-headquartered May Health has secured a European CE mark for its Anavi system to address infertility in women with polycystic …
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FDA removes patient-identifiable RWE requirement for device submissions
The US Food and Drug Administration (FDA) is removing a limitation on the use of real-world evidence (RWE), clearing the …
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FDA approves Dilon’s intraoperative margin assessment device
The US Food and Drug Administration (FDA) has granted approval for Dilon Technologies’ MarginProbe 2, a next-generation intraoperative margin assessment …
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Helio Genomics and LiverRight team up for early detection of liver cancer
Helio Genomics and LiverRight have entered a partnership to improve access to early liver cancer detection in the US. The collaboration …
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Medical Device Network Excellence Awards 2025: Advita Ortho’s Newton® Balancing Technology for Knee Replacement Surgery
Advita Ortho, a global medical technology company, has won the Innovation award in the 2025 Medical Device Network Excellence Awards …
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Medical Device Network Excellence Awards 2025: Advita Ortho’s Newton® Balancing Technology for Knee Replacement Surgery
Advita Ortho, a global medical technology company, has won the Innovation award in the 2025 Medical Device Network Excellence Awards …
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Olympus launches second VC fund with $150m commitment
Olympus Corporation has committed $150m to a new venture capital (VC) fund, aiming to deploy the capital to promising medtech …
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Philips doubles down on image-guided therapy with SpectraWAVE acquisition
Philips has signed a deal to acquire enhanced vascular imaging (EVI) product developer SpectraWAVE, expanding the Dutch medtech giant’s minimally …
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Vaxxas gains Australia’s TGA licence to manufacture HD microarray patch
Vaxxas has received a manufacturing licence from Australia’s Therapeutic Goods Administration (TGA) for its high-density microarray patch (HD-MAP) for clinical …
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FDA approves P&F’s transcatheter bicaval valve system trial
The US Food and Drug Administration (FDA) has granted approval to P&F USA to begin the randomised, controlled TRICAV II …
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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 …
