Angel Medical Systems, a developer of continuous intracardiac ischemia monitoring technologies, has raised $27.5m in the financing round. In the round, Angel's existing venture capital, strategic partner and investors, as well as a ...
Tags: clinical trial, financing round, clinical technology, investment
US medical center, Mayo Clinic, has signed a pre-clinical research agreement with MagForce. Under the agreement, Mayo Clinic will begin a research program to investigate the preclinical efficacy of the MagForce's NanoTherm therapy in ...
Aptus Endosystems, a developer of endovascular aneurysm repair (EVAR) technology, has completed $25m series BB equity financing. Aptus will use the finance to expand commercialization of its HeliFX Aortic Securement system in the US and ...
Tags: Aptus Endosystems, endovascular aneurysm repair technology
Cartiva, a developer of orthopedic implants, has completed enrolling patients in its MOTION trial. The prospective, multi-center trial, which has enrolled 233 patients across Canada and the UK, is designed to assess the company's ...
Tags: Cartiva, clinical trial, clinical technology
Endosense, a provider of cardiac technologies, has completed enrolling patients in its Toccastar clinical study. The prospective, randomized, multi-center investigational device exemption trial, which enrolled 300 patients with ...
Tags: Endosense, Toccastar clinical study, cardiac technologies
Anaxsys has filed its respiR8 continuous respiratory rate counter's 510(k) premarket notification application with the US Food and Drug Administration (FDA) for regulatory clearance. Electrochemical respiR8 device comprises a patented ...
Tags: Anaxsys, Electrochemical respiR8 device, FDA
The US Food and Drug Administration (FDA) has cleared VuCOMP's premarket approval (PMA) application for new version of M-Vu computer-aided detection (CAD) system. The new CAD system, M-Vu version 2, is designed for use in digital ...
Tags: FDA, CAD system, clinical technology
BioControl Medical is set to commence the second phase of its INcrease Of VAgal TonE in Heart Failure (INOVATE-HF) study, following the US Food and Drug Administration (FDA) approval. The CardioFit system, which comprises a stimulator, a ...
Tags: BioControl Medical, INcrease Of VAgal TonE in Heart Failure study
The US Food and Drug Administration (FDA) has granted approval to Pulmonx to commence an investigational device exemption (IDE) pivotal clinical study of its Zephyr Endobronchial Valve (EBV) therapy, designed to treat emphysema. The ...
Tags: FDA, Endobronchial Valve therapy, emphysema, Zephyr EBV therapy
Abiomed has received US Food and Drug Administration's (FDA) investigational device exemption (IDE) to begin a pivotal clinical study of its Impella Right-side Percutaneous (RP ) pump. The percutaneous heart pump is implanted through a ...
Tags: percutaneous heart pump, Impella Right-side Percutaneous pump, FDA
ParadigmSpine has obtained premarket approval (PMA) for its motion preserving interlaminar stabilization device from the US Food and Drug Administration (FDA). The minimally invasive coflex device is designed for treating moderate to ...
NuVasive has gained premarket approval (PMA) for its cervical motion preserving system from the US Food and Drug Administration (FDA). The PCM cervical disc device, which is comprised of superior and inferior endplates, is designed for ...
Tags: cervical motion preserving system, PCM cervical disc device, FDA
Globus Medical has obtained premarket approval (PMA) from the US Food and Drug (FDA) for its articulating intervertebral disc replacement device, designed for patients with intractable symptomatic cervical disc disease (SCDD) between ...
Tags: FDA, articulating intervertebral disc replacement device
GeNO has received four additional US patents for its proprietary nitric oxide (NO) generation chemistry and delivery technology. The patent No. 8,211,368 describes the conversion of nitrogen dioxide (NO2) to NO where NO2 is stored as ...
Tags: US patent, clinical technology, clinical research, GeNO
Molecular diagnostics company Exact Sciences has submitted to the US Food and Drug Administration(FDA)the first module of the premarket approval(PMA)application for its stool DNA colorectal cancer screening test. The first modular ...
Tags: molecular diagnostics, Exact Sciences, PMA application