Sequana Medical NV has reported additional data on safety, survival and quality of life from its POSEIDON pivotal study in North America, evaluating its Alfapump device used in the treatment of patients with recurrent or refractory ascites caused by liver cirrhosis. The data were recently presented at the European Association for the Study of the Liver 2023 congress in Vienna.
The difficulties in rolling out the EU’s Medical Device Regulation are well known, but the attendant delays continue to exert ripple effects in other markets. The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has formally extended the time frame for acceptance of existing CE marked devices into the U.K. market, another demonstration of the ongoing turmoil associated with the herky-jerky deployment of the MDR.
The U.K. Competition and Markets Authority (CMA) has declared its opposition to a proposed merger between Cochlear Ltd. And Oticon Medical A/S, two of the prime movers in the bone conduction implant space.
The European Society of Hypertension (ESH) has recommended that renal denervation (RDN) be offered as an adjunctive therapy to patients with resistant hypertension. Releasing new and updated guidelines on the management of arterial hypertension, the ESH said recent randomized controlled trials showed that endovascular RDN can be associated with a significant, albeit not marked, office and ambulatory blood pressure reduction in patients with uncontrolled hypertension.
Vesalius Biocapital Partners Sàrl has called a first close on its fourth fund at €95 million (US$103 million) and now is targeting a total of €150 million, with new investors to be accepted on a "rolling closing" basis until the final close in 2024.
Isotope Technologies Munich SE (ITM) raised $280 million to support the expansion of its broad targeted radionuclide therapies oncology pipeline. This equity investment round was led by Temasek holdings Pte Ltd. with participation from Blackrock Alternatives, Qatar Investment Authority, Nextech Invest Ltd., Athos KG and Carbyne Equity Partners GmbH.
The U.K. government created a new £21 million ($US26.55 million) fund to accelerate the roll out of artificial intelligence (AI) diagnostics and treatment tools across the NHS. The AI Diagnostic Fund will enable hospitals to bid for funding to speed up the deployment of the most promising AI imaging and decision support tools to help patients with cancers, strokes and heart conditions.
Gleamer SAS reported closing a series B round of $29.6 million to help expand its portfolio of artificial intelligence (AI) systems for radiologists and ramp international expansion. The exercise was led by Supernova Invest SAS who put up $11 million, joined by Heal Capital SAS with $5.5 million.
The U.K. National Institute for Health and Care Excellence (NICE) has undertaken a public consultation for a series of proposed changes to its procedures for evaluating medical devices and other medical technologies that could speed up these reviews. This new process would require a less time-consuming approach to evaluating lower-risk technologies that would not only turn around such evaluations more rapidly but would also leave more resources available for higher-risk products that would also enjoy a timelier review, thus potentially accelerating adoption of all these products in the National Health System.
The imaging and advanced guidance for workflow optimization in interventional oncology consortium (IMAGIO) consortium of clinical partners in the EU, led by Royal Philips NV, has been awarded $26 million under the Innovative Health Initiative (IHI) to carry out research into less invasive cancer therapies.
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