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

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

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

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 ...
Medical Device Network

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 ...
Medical Device Network

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 ...
Medical Device Network

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 ...
Medical Device Network

Roche gains CE Mark for bacterial vaginosis/candida vaginitis assay

Roche has secured CE Mark approval for its cobas BV/CV assay to support the diagnosis of infectious causes of vaginitis.
Medical Device Network

Pulse Biosciences and MD Anderson to study nPulse for thyroid cancer

Pulse Biosciences has partnered with The University of Texas MD Anderson Cancer Centre to investigate the use of the nPulse ...
Medical Device Network

Lunit seeks FDA clearance for breast cancer risk prediction model

Lunit has announced the submission of a 510(k) premarket notification seeking clearance from the US FDA for its breast cancer ...
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 ...