Grail LLC reported a new study with the U.K.’s NHS to assess the clinical utility of its Galleri multi-cancer early detection test (MCED) for reducing late-stage cancer diagnoses. Menlo Park, Calif.-headquartered Grail presented the study design during the American Society of Clinical Oncology (ASCO) meeting in Chicago. The randomized controlled trial will enroll 140,000 asymptomatic participants aged 50-77 living across England to determine if Galleri can find cancers at an early stage when they are less advanced.
Medtech Europe, the European trade association for the medical technology industry covering diagnostics, medical devices and digital health, has just adopted a new code of ethical business practice.
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.
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.
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.
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.
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.
LONDON – The confluence of Brexit and pandemic has hit regulators in Europe hard this year, with the workload of assessing COVID-19 vaccines and antivirals made all the more onerous by the loss of expertise suffered by both the EMA and the U.K. Medicines and Healthcare products Agency (MHRA) as their close relationship was severed.
DUBLIN – After a COVID-19-fueled funding bonanza, European biotechnology appears to have reverted to the mean in the second half of this year. Firms engaged in drug development raised a total of $1.886 billion in disclosed transactions during the third quarter (Q3) of 2021. That represents a 44% fall on the total raised in Q2, which was itself down 46% on the Q1 total. The sector has raised a total of $11.44 billion so far this year, meaning that last year’s highwater mark of $12.682 billion is still within reach – but only just. The funding momentum appears to have stalled for now.
PARIS – Biospectal SA has just closed a $4.3 million seed round to scale its Optibp smartphone blood pressure monitoring application and data platform technology worldwide.
