Endotronix Inc. reported positive data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella pulmonary artery pressure sensor system in New York Heart Association (NYHA) class III heart failure (HF) patients.
The French and German governments have just announced a major project to develop a digital platform for the early detection of new respiratory pathogen epidemics, and then monitor their spread and inform decisions on appropriate counter measures. The COVID-19 crisis has confirmed the need for a resilient multi-stakeholder surveillance and control system to manage current and future epidemics or pandemics.
Primary care doctors in England have been told by the National Institute for Health and Care Excellence (NICE) to prescribe a digital therapeutic instead of sleeping tablets for patients suffering with insomnia. Sleepio, an app developed by London-based Big Health Ltd. that uses an algorithm to provide personalized cognitive behavioral therapy (CBT), could benefit up to 800,000 people, according to NICE. It is recommending use of the app as an effective alternative to drugs such as zolpidem and zopiclone, after weighing evidence from 28 studies, including 12 randomized controlled trials.
Detecting the spread of cancer is a high priority for most health systems, but the U.K. National Health Service currently has a limited range of options when it comes to detecting breast metastases. That may change soon thanks to a review by the National Institute of Health and Care Excellence (NICE), which may endorse the use of the Sentimag system with Magtrace.
Robocath SAS presented results from the R-Evolution European clinical study assessing the safety and efficacy of its R-One robot for coronary angioplasty procedures. The study, which included 62 patients across six European centers, met all three primary endpoints, showing 100% clinical success, >95% technical success, and 84.5% average reduction in physician radiation exposure.
The European Commission (EC) has proposed new legislation directed toward formation of a European Health Data Space (EHDS), which is nominally intended to address some perceived gaps in the General Data Protection Regulation (GDPR). While this legislative proposal seems to interact with both the GDPR and pending EU legislation on artificial intelligence, the EHDS takes on the massive challenge of compulsory interoperability of electronic health records (EHRs). The EC unveiled the proposal with an emphasis on health data accessibility, although both the European Council and the European Parliament will now have their say over how the legislation will ultimately read.
Rennes University Hospital in France has just this April completed a surgical procedure in the operating room wirelessly, thanks to the 5G network. Cardiologist Erwan Donal performed a heart operation there on a simulation manikin, monitored remotely from Athens, Greece, by heart surgeon Alexandros Stefanidis, from the department of cardiology at the General Hospital of Nikea.
Apollo Global Management Inc. is taking a minority equity interest in European venture capital firm Sofinnova Partners, pledging to commit of up to €1 billion (US$1.04 billion) in managed capital to the latter’s investment coffers.
Getinge AB is acquiring 100% of the equity in fluorescence imaging company Fluoptics SAS, a company using the technology as an aid to surgery. Getinge will, through its subsidiary Getinge Infection Control SAS, acquire all outstanding shares in Fluoptics and will pay around $27 million in cash on closing the deal.
Germitec SA has raised €11 million (US$11.6 million) to finance commercial scale-up, as it prepares to submit for FDA 510k approval of its ultrasound probe disinfection system.
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