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BioWorld - Monday, January 12, 2026
Home » Topics » Europe, BioWorld MedTech

Europe, BioWorld MedTech
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Caredx secures CE mark for Alloseq HCT amid investor uproar

May 25, 2022
By Catherine Longworth
Organ transplant diagnostic company Caredx Inc. has received CE marking for its Alloseq HCT chimerism testing kit and Alloseq HCT interpretation software for use in patients who have received hematopoietic cell transplantation (HCT). The NGS-based solution is used to monitor engraftment and evaluate the success of a hematopoietic stem cell transplant by measuring the relative ratio of the recipient and the donor cell population post-transplantation.
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U.K. flag on stethoscope

NICE inks guarded recommendation for aortic root support for Marfan syndrome patients

May 24, 2022
By Mark McCarty
Those who are burdened with Marfan syndrome face a lifetime of multi-organ system issues including potential aortic aneurysm, but help may be on the way in the U.K. The National Institute of Health and Care Excellence (NICE) has issued a recommendation that these patients be treated with personalized external aortic root support (PEARS) to treat both aortic root expansion and aortic dissection, although the agency indicated that this procedure is not quite ready for routine use in the National Health Service.
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Patient holding Cordella reader over heart

Endotronix reports early data for heart failure sensor

May 24, 2022
By Catherine Longworth
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. 
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Consortium developing AI platform for early detection, monitoring of respiratory pathogen epidemics

May 23, 2022
By Bernard Banga
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.
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Clock with woman awake in bed in background

NICE recommends Sleepio digital app over sleeping pills for insomnia

May 20, 2022
By Nuala Moran
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.
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Sentimag device in office

Cost, site of service prompts new NICE endorsement of Magtrace and Sentimag

May 20, 2022
By Mark McCarty
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.
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R-One
EuroPCR

Robocath reports results from robotic coronary angioplasty study

May 18, 2022
By Catherine Longworth
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.
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European Commission headquarters

European Commission’s health data legislation starts with mandatory EHR interoperability

May 17, 2022
By Mark McCarty
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.
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5GTours

French university hospital experiments with a wireless 5G operating room

May 16, 2022
By Bernard Banga
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.
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3D Euro symbol

Biotech, pharma ‘dance’ ongoing as Apollo commits as much as €1B to Sofinnova

May 16, 2022
By Randy Osborne
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.
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