French startup Affluent Medical SA has launched a European pilot study in humans of its native-like transcatheter mitral valve technology. The Epygon valve is designed to restore the normal blood flow vortex in the left side of the heart and treat left ventricle disease, particularly in so-called “functional” patients.

LONDON – Epidarex Capital announced the closure of its £102.1 million (US$126.3 million) third fund, which will invest in very early stage biomedical and med-tech spin-outs from high-class but “under-ventured” universities in regions of the country where venture money is in short supply.

PARIS – Stilla Technologies SAS, of Villejuif, France, is supplying a new, cost-effective approach for COVID-19 testing by combining its digital polymerase chain reaction (PCR) technology with the group testing method. “This approach greatly increases testing capacity and meets the highest quality standards,” Rémi Dangla, co-founder and CEO of Stilla Technologies, told BioWorld.

Lausanne, Switzerland-based Debiotech SA and Neokidney BV, of Amsterdam, have created Nextkidney SA to lead the development and commercialization of Neokidney, a lightweight, plug-and-play, home hemodialysis device.

PARIS – Agfa-Gevaert Group NV, of Mortsel, Belgium, has sold parts of its health care information technology (IT) business to Italy’s Dedalus Holding SpA for $1.1 billion. The divested interests include health care information solutions activities and integrated care activities in Germany, Austria, Switzerland, France and Brazil, as well as certain IT imaging activities in these territories. It represents about half of Agfa Healthcare’s business.

Medtronic plc, of Dublin, has gained CE-marking approval for its Minimed 780g system, a next-generation closed-loop insulin pump for people with type 1 diabetes between the ages of 7 and 80 years old. The advanced hybrid closed-loop system (AHCL) features an advanced autocorrection algorithm and Bluetooth connectivity.

PARIS – Robocath SAS, of Rouen, France, has secured a new $43 million funding round to boost roll-out of its R-One robotic system for treating vascular disease. This series C funding was led by Hong Kong-based Microport Scientific Corp.

LONDON – Base Genomics Ltd. has raised $11 million in an oversubscribed seed round to commercialize a new liquid biopsy technology for detecting DNA methylation, invented in the U.K. at the Ludwig Institute for Cancer Research at Oxford University.

PARIS – Uromems SAS, of Grenoble, France, reported the completion of a series B round of $17.5 million to advance development of its implantable mechatronic device for treating stress urinary incontinence.

The implementation date for the EU’s new med-tech regulatory framework has been pushed back a year, giving device makers much-needed breathing room for compliance work. At the same time, the International Organization for Standardization (ISO) has not fulfilled the planned May update of its device clinical investigations standard, ISO 14155.