As the U.K. pursues its divorce from the EU, smaller U.S. drug and device companies could be caught disproportionately in the collateral damage. Many of them already struggle with the cost of duplicative regulatory requirements involved in marketing their products in the EU, but those costs could increase under Brexit, according to a report released last week by the U.S. International Trade Commission on trade-related barriers impacting U.S. small- and medium-sized enterprises (SMEs) that export to the U.K.

PARIS – Carmat SA, from Vélizy Villacoublay, France, has just raised $66 million from European specialist investors in the life sciences and medical technologies sector.

The emerging methodology of federated learning can overcome many of the ethical and privacy obstacles preventing patient data from being pooled for analysis, according to research published this week.

A large-scale U.K. clinical trial of a portable electronic nose device has shown it is possible to distinguish bacterial from viral infection in an unselected population of patients presenting with a respiratory tract infection (RTI) symptoms, at the point of care.

DUBLIN – Versantis AG raised CHF16 million (US$16.1 million) in a series B round to progress clinical trials of a liposomal-based fluid in development for eliminating ammonia and other toxic metabolites from the circulation of patients in acute stages of liver failure who are undergoing peritoneal dialysis.

Croívalve, a Dublin-based startup supported by Enterprise Ireland that is developing a treatment for tricuspid regurgitation (TR), recently secured €4 million (US$4.4 million) in additional financing. The financing includes €2.5 million from the EU's Horizon 2020 SME Instrument grant and €1.5 million from Broadview Ventures and current investors Halo Business Angel Network Medtech and Irrus Syndicates, Atlantic Bridge University Fund and Sos Ventures. The funding will accelerate the development of the company's technology into first-in-human (FIH) studies.

LONDON – Kaia Health Software GmbH closed an $8 million funding round that it will use to accelerate U.S. commercialization of its digital health apps for managing musculoskeletal disorders and chronic obstructive pulmonary disease (COPD).

HONG KONG – Dreamed Diabetes Ltd., of Petah Tikva, Israel, has received both FDA clearance and the CE mark for an insulin dosing decision support software based on artificial intelligence (AI).