Organoids grown from cholangiocytes – the epithelial cells of the bile duct – are poised to be used in ex vivo cell therapy to increase the number of donated livers that are suitable for transplant, and also for direct bile duct repairs. The organoids have been shown to be effective in correcting defects in mouse models and in perfused donated livers. They are now being tested in large animal models.

If the SARS-CoV-2 virus has achieved anything useful in the world of in vitro diagnostics, it’s that the associated pandemic has shone a bright and unsparing light on the respective merits of diagnostic and surveillance testing. Harvard University’s Michael Mina, an assistant professor of epidemiology, was one of several academic researchers who took up the gauntlet yet again in opposition to what they characterized as a gross misunderstanding of the respective roles of these types of tests, a misunderstanding they said must be addressed if the pandemic is to be corralled.

In a Feb. 17 update to its guidance on managing clinical trials during the COVID-19 pandemic, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) said all sponsors of ongoing clinical trials for indications other than treatment or prevention of COVID-19 are required to evaluate the impact a COVID-19 vaccine may have on the trial.

LONDON – The EU is taking concerted action to detect new variants of SARS-CoV-2, investing €225 million (US$270 million) to increase viral genome sequencing to 5% of positive cases across Europe, and to carry out research on their evolution and transmissibility.

Cardiacsense Ltd.’s medical watch received CE mark for the detection of atrial fibrillation and heart rate variability monitoring. The watch provides continuous, long-term monitoring of heart arrhythmias without cumbersome external devices or invasive implants. The European clearance does not require a prescription for use and will enable the Caesarea, Israel-based company to begin distribution under a number of agreements the company signed in 2020.

Blue Ocean Spine GmbH has won a major investment from SHS GmbH, also from Tuttlingen in Germany, to develop its next-generation functional spinal implant. The two companies are declining to disclose the size of the series A investment.

LONDON – After a number of equivocal small studies, the U.K. Recovery trial has applied its heft to turn in statistically significant evidence that the rheumatoid arthritis treatment Roactemra (tocilizumab) reduces mortality in hospitalized COVID-19 patients.

PARIS – Ecential Robotics SAS has just secured $120 million series C funding in equity and debt financing, to support the manufacturing and commercial development of its robotic platform for spinal surgery. This is the largest financial transaction undertaken by any med-tech company in France.

LONDON – It began life as a legal tidy-up of post-Brexit regulatory issues, but the Medicines and Medical Devices bill that emerged from its final reading last week is in a significantly different form. Most notably, the bill legislates for the creation of a national register of all implantable medical devices and the appointment of a patient safety commissioner to act a single port of call and advocate for patients when devices fail.