Medtrace Pharma A/S raised $30 million in a series B round to ramp its platform for production, infusion and analysis of ¹⁵O-water in medical imaging. Swiss-based Swisscanto Invest, along with fund managers ATP and Bankinvest group from Denmark, are the lead investors. “We can now ramp our European and U.S. expansions plans in myocardial perfusion imaging and in other indications in need of perfusion data,” Martin Stenfeldt, CEO and co-founder of Medtrace, told BioWorld.

The European Commission (EC) unveiled on Monday its new joint implementation and preparedness plan for the European Union’s In Vitro Diagnostic Regulation (IVDR). It sets forth priority actions, noting “the implementation of the IVDR has proven to be a very challenging task,” exacerbated in the response to the COVID-19 pandemic “despite the efforts undertaken by all” to transition.

PARIS – Arkhn SAS has finalized a $5 million seed round to help drive health care institutions towards secure and efficient data management. This financing round has been led jointly by the two French venture capital firms, Kurma Partners SA and Newfund SA, though their respective funds Kurma Diagnostics II and Newfund II.

LONDON – The U.K. health technology assessment agency, NICE, has called for a halt to the use of transvaginal laser therapy in the treatment of urinary stress incontinence and vaginal atrophy, saying there is not enough evidence of long-term safety, or proof that the procedures are effective.

Dsruptive Subdermals AB has completed a clinical showing body temperatures tracked by its chip implants are comparable to temperature readings from standard clinical thermometers. The Stockholm-based startup is now offering its injectable implants as an open platform for researchers seeking efficient, low-cost tools to monitor changes in body temperature.

Data on the prevalence of diabetes in the U.S. show that non-Hispanic white people are least likely to suffer from the disease. Yet to date most genetic studies of the glycemic traits that are used to diagnose and monitor type 2 diabetes and cardiometabolic health have focused on individuals of European ancestry.

PARIS – French public sector investment bank Bpifrance SA is consolidating its commitment to e-health startups, with the announcement of a doubling in size of its Fonds Patient Autonome [Patient Independence Fund] to more than $120 million. Three further partners from France have also subscribed to this new fund. These are the Banque des Territoires – an offshoot of the French national public sector savings and investment fund, Caisse des Dépôts et Consignations; the Harmonie Mutuelle insurance group; and the foundation hospitals Groupe Vivalto Santé SA.

Veracyte Inc. has agreed to acquire Haliodx SAS in a €260 million (US$318.1 million) deal to accelerate growth and strengthen its global footprint in cancer diagnostics. The cash and stock transaction will give Veracyte a manufacturing presence in Europe and expand its cancer diagnostics scope to eight of the 10 top cancers by U.S. incidence.

Aktiia SA’s cuff-less blood pressure monitor – a connected optical system for continuous monitoring – has launched in Austria, France, Germany, Ireland, U.K. and Switzerland. Aktiia’s monitor is a bracelet that includes a photoplethysmography sensor with a silicon diode receptor capable of measuring the pulse to within an accuracy of ±5 beats per minute, a communication module and a rechargeable lithium-ion battery.

The official compliance date for the European Union’s Medical Device Regulation (MDR) is now officially in force after a delay of two years. One of a number of unfortunate side effects is that the mutual recognition agreement (MRA) between the EU and the Swiss government has lapsed, and the European Commission has indicated that the two sides have not come to terms over the impasse.