Medical Device Network

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 way ...
Medical Device Network

Helio Genomics and LiverRight team up for early detection of liver cancer

Helio Genomics and LiverRight have entered into a partnership designed to improve access to early liver cancer detection in the US.
Medical Device Network

FDA approves Dilon’s intraoperative margin assessment device

The FDA has granted approval for Dilon Technologies’ MarginProbe 2, an intraoperative margin assessment device for breast ...
Medical Device Network

Olympus launches second VC fund with $150m commitment

Olympus Corporation has committed $150m to a new VC fund, aiming to deploy the capital to promising medtech startups in the ...
Medical Device Network

Philips doubles down on image-guided therapy with SpectraWAVE acquisition

Philips has inked a deal to acquire enhanced vascular imaging (EVI) product developer SpectraWAVE, expanding the Dutch ...
Medical Device Network

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 ...
Medical Device Network

FDA approves P&F’s transcatheter bicaval valve system trial

The FDA has granted approval for P&F USA to begin the TRICAV II pivotal trial of the TricValve transcatheter bicaval valve ...
Medical Device Network

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 ...
Medical Device Network

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 ...
Medical Device Network

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 ...
Medical Device Network

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 ...
Medical Device Network

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 to improve attention span in adult patients with attention ...