PARIS – Robocath SAS has concluded an initial clinical study in Europe to demonstrate the safety and efficacy of robotic coronary angioplasty performed using its R-One platform. Sixty-two patients from six European hospitals participated in the R-Evolution clinical study. The study was aimed at assessing the safety and efficacy of the R-One robotic assistance platform.

Investors have backed Oxford University spin-off ONI Ltd. with $75 million to push commercialization of its nanoimaging technology. The startup’s flagship product Nanoimager is a desktop, super resolution microscope capable of visualizing, tracking, and imaging individual molecules in living cells with 20 nm resolution. The technology is already in use with biomedical companies to aid development of more efficient, targeted therapies.

The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) unveiled a proposal to overhaul its requirements for clinical trials for drugs and devices, just one of several significant regulatory proposals in recent months. One of the proposed changes would be to require more patient engagement in the design of trials, while another feature would allow sponsors to go through the MHRA process and an ethics review in a single application, thus potentially streamlining the up-front work required for these studies.

Clinisys Inc. has signed a deal to buy laboratory information company Horizon Lab Systems LLC and combine Sunquest Information Systems under the Clinisys brand. The resulting group will be one of the world's largest laboratory informatics organizations. Clinisys and Sunquest share the same parent company – Roper Technologies Inc., which trades on the NYSE stock exchange. The addition of Raleigh, N.C.-based Horizon provides Clinisys with expertise in the public health, environmental, water quality, toxicology and agriculture markets.

LONDON – Engitix Therapeutics Ltd. has raised $54 million in a series A round to advance early programs arising from its human extracellular matrix (ECM) target discovery platform towards the clinic with the support of new partner and equity investor Dompé Farmaceutici SpA.

PARIS – Healshape SAS is preparing a $6.8 million series A round to develop a 3D bioprinted breast implant obtained from the patients' own cells. Supported by Pulsalys SAS, Lyon Saint-Etienne’s technology transfer acceleration company, this startup from Villeurbanne, France, has already benefited from more than a million dollars of French public funding and subsidies.

Oslo-based med-tech company Observe Medical ASA has acquired ultrasound technology firm Biim Ultrasound AS for €18.5 million (US$20.9 million). The company’s combined portfolio includes Observe’s automated, digital urine meter, Sippi, and Biim’s wireless ultrasound probe, Biim, which received 510(k) clearance in 2018. The ultrasound technology is specifically used to guide needle and catheter insertions for dialysis and vascular access procedures and is currently in use at Fresenius Kidney Care’s U.S. dialysis centers.

PARIS – The new European regulation on medical devices came into force on May 26, 2021, one year later than planned, due to the COVID-19 pandemic. This European medical device regulation (MDR) modifies the conformity assessment procedure for medical devices in the 27 countries of the European Union, repealing two council directives implemented in the early 1990s.

Following Philip Morris International Inc.’s controversial takeover of respiratory drug firm Vectura plc, British American Tobacco plc (BAT) is also making inroads into medical research with U.K.-based Kbio Holdings Ltd., a biotech focused on plant-based medicine.

Hoping to improve Europe’s clinical trial environment, EU officials launched an initiative Jan. 13 to transform how clinical trials are designed and conducted.