LONDON – A new U.K. study indicates the Pfizer Inc./Biontech SE COVID-19 vaccine is less effective against the India variant of the SARS-CoV-2 virus that was designated as of global concern by the World Health Organization (WHO) on May 10.
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.
LONDON – Adding to the immediate and obvious toll of serious illness and death, COVID-19 seems likely to be fueling development of resistance to antibiotic drugs, according to the findings of the most comprehensive analysis to date.
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.
LONDON – Ibex Medical Analytics Ltd. has secured a second CE marking for its Galen artificial intelligence decision support system for automated interpretation of tumor biopsies, adding breast cancer to the approval in prostate cancer secured just over a year ago. The CE mark follows results from a blinded, multicenter clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Ibex says that in the trial Galen breast demonstrated very high accuracy in detecting various types of breast cancer.
The European Commission's (EC) Medical Device Coordination Group (MDCG) has provided a set of templates to fulfill European Medical Device Regulation (MDR) requirements on submitting clinical investigation application and notification documents in the absence of the European database on medical devices (EUDAMED).
With $41 billion in sales, the medical technology market in Germany leads Europe, followed by France and Italy, which each manage only half the sales of Germany each month. The U.K., in fourth place, barely sees one-fifth of Germany's revenues, according to a report from BVMed, the German association of medical device manufacturers. German firms also reported a 4.9% reduction in business in 2020 due principally to the COVID-19 pandemic.
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