LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) is inviting manufacturers to submit electronic cigarettes for approval as medical devices, after drawing up new guidance on the standards that will be required for approval. The move means the U.K. could become the first country in the world where e-cigarettes are available on prescription as smoking cessation aids.

PARIS – Defymed SAS reported the formation of the Decapes consortium, which brings together the Institute of Chemistry and Processes for Energy, Environment and Health (ICPEES) and the specialist microtechnology and biomaterials service provider for med-tech companies, Statice. This French consortium is working on a minimally invasive version of Defymed's Mailpan device, which will extend the application range for this artificial pancreas to include other chronic pathologies besides type 1 diabetes.

PARIS – Mauna Kea Technologies SA reported the commercial launch of a new generation of its in vivo cellular imaging for diagnostics in gastroenterology. At the same time, the company is deploying its new needle-based and miniprobe-based multidisciplinary confocal laser endomicroscopy platform in the U.S., as well as in France, Germany and Italy.

Zap Surgical Systems Inc. is debuting its noninvasive brain tumor treatment to the European market through an agreement with Centre de Cancérologie de la Porte de Saint-Cloud (CCPSC). The Boulogne-based center, which is part of the American Hospital of Paris, said it expects patients to access the treatment by Fall 2022.

DUBLIN – Novadip SA raised €19 million (US$22.1 million) in a first close of a series B round to progress its autologous bone regeneration therapy, NVD-003, on either side of the Atlantic. The company is also working on an allogeneic regenerative approach, which is still preclinical.

To help better utilize real-world data in drug development, the EMA published its final guideline Oct. 26 on the use of registry-based studies to support regulatory decision-making.

LONDON – The U.K. Health Security Agency (UKHSA) has designated an offspring of the Delta variant of SARS-CoV-2 as a “variant under investigation” after uncovering some early evidence it may have an increased growth rate.

Iceni Diagnostics Ltd. is accelerating efforts to commercialize a diagnostic for detecting COVID-19 using sugars rather than antibodies. Lateral flow diagnostics (LFDs) have been widely used during the COVID-19 pandemic to diagnose people with an active infection. The tests use antibodies, which attach to the SARS-COV-2 virus but Iceni’s Host-Pathogen Glycan Recognition technology has been touted as a potential alternative due to its polymer approach.

PARIS – Quantum Surgical SAS has closed $48 million in funding to finance the commercial launch of its integrated robotics platform for percutaneous treatment in liver cancer. The round was led by Hong Kong-based Ally Bridge Group who invested $24 million, or half the total amount raised. Three banks also participated in this funding round: The European Investment Bank, Bpifrance and Caisse d’Epargne Languedoc Roussillon.

PARIS – The French National Authority for Health (HAS) is expanding the available range of novel autologous technologies reimbursed in the context of breast reconstruction following ablative surgery. In doing so, the HAS is paving the way towards reimbursement for novel autologous techniques in general.