Mfb Fertility Inc. received CE mark approval for its Proov PdG tests, giving European women direct access to information about ovulation without a prescription. The test enables a woman to test her urine for production of sufficient progesterone to confirm ovulation and favorable conditions for conception.
LONDON – CMR Surgical Ltd. has once again broken the record for a private financing round by a European med-tech company, raising $600 million in a series D funding round. That follows on from two other record-breaking rounds, in which the Cambridge, U.K.-based CMR raised $240 million in a series C in September 2019 and $100 million in the series B round that closed in May 2018. These earlier rounds enabled CMR to complete development and install the first commercial versions of its Versius surgical robots. Now the series D will push the company through to profitability, the company said.
LONDON – There has been a lukewarm reception from the industry to the latest developments in the plan to establish a European health technology assessment (HTA) agency, with concerns from pharma that member states will be able to pick and choose whether to apply joint evaluations in national reimbursement and access negotiations.
PARIS – In France, the Haute Autorité de Santé, or National Health Authority (HAS), recently reported the entry into force of a new plan for "temporary" adoption under social security for innovative medical devices. The aim is to speed up access to the French insurance reimbursement market for medical technology addressing unmet or poorly met clinical needs in the context of serious or rare conditions, or which help disability in France.
PARIS – Aptargroup Inc. is negotiating to buy Voluntis SA in a move that would complement its existing digital solutions portfolio and expand services to address multiple conditions and chronic diseases. "By being part of Aptar, we will be able to pursue a common ambition aimed at providing a complete digital health platform combining connected devices and digital therapeutics," Pierre Leurent, CEO and co-founder of Voluntis, told BioWorld.
DUBLIN – In a busy week at the EMA, its Committee on Human Medicinal Products (CHMP) nodded through eight marketing applications at its June meeting. The haul included a chimeric antigen receptor T-cell (CAR T) therapy, three antibodies, including a biosimilar, and two new small-molecule drugs, as well as two generics.
Boehringer Ingelheim GmbH has begun a three-year collaboration with researchers at Australia’s WEHI, looking into a potentially powerful approach to targeted protein degradation also being studied by its German rival Merck KGaA.
PERTH, Australia – Starpharma Holdings Ltd. is pausing sales of its antiviral nasal spray, Viraleze (SPL-7013), in the U.K. after its retail partner, Lloydspharmacy, received a letter from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) related to promotional claims made about the antiviral with respect to SARS-CoV-2 and COVID-19.
LONDON – The U.K. is setting up a service for developers and users of artificial intelligence (AI) to provide a single source of advice covering all requirements for the technology, from clinical research to regulatory scrutiny, health technology evaluation and through to commissioning.
Avicenna.AI has enjoyed a head-spinning series of regulatory nods for its artificial intelligence (AI)-based solutions for serious vascular conditions including stroke, pulmonary embolism (PE) and aortic dissection. The Marseille, France-based company gained CE mark for its tool that quantifies the severity of a stroke based on a CT scan of the brain and displays regions that have suffered infarcts in late May, followed by CE mark and FDA 510(k) clearance for its product that permits emergency triage of PE and aortic dissection from CT-scan imaging in early June.