Methinks Software SL (dba Methinks.AI), a digital health company, is working on the U.S. FDA submission for its artificial intelligence (AI)-based stroke triage software, which will aid in the detection of acute stroke, after recently receiving CE mark certification.
Feops NV hopes to raise €10 million (US$10.67 million) in a series C fundraising round that will allow the company to scale up its operations worldwide. This follows the release of a study in JACC: Cardiovascular Interventions which revealed that its cloud-based platform, Feops Heartguide, significantly improved efficiency and outcomes of left atrial appendage closure (LAAC) procedures.
Coloplast A/S is about to launch a new single-use male intermittent catheter featuring new technology designed to reduce the risk of urinary tract infections (UTI). “The Luja device, with its micro-hole zone technology, is going to drive future growth in our continence care division,” Coloplast Chief Financial Officer Anders Lonning Skovgaard told BioWorld.
CN Bio Ltd. launched the Physiomimix single-organ higher throughput system commercially in hopes it will foster the adoption of microphysiological systems which increase productivity, improve data quality and offer cost-effective solutions for drug discovery.
The France Biotech business association released its latest annual survey covering the health-tech sector in France. According to the 2022 edition of the Panorama, 1,440 med-tech, 880 bio-tech and 4,000 health and artificial intelligence software companies have been surveyed, responsible between them for $1.4 billion in sales revenues and 14,000 direct jobs, not counting the 2,200 new jobs planned for 2023 mainly in R&D, production and support services.
The fundraising environment for startups in med tech is expected to continue to be challenging for at least another year as public markets remain closed and private investors favor companies that have already de-risked their products. One of the major issues in the U.K. and Europe is that the IPO markets are “pretty much shut” and “our public markets aren’t working”, therefore companies are having to rely on private funding, with venture capital being one of those sources, said Robert Tansley, partner, at venture capital fund Cambridge Innovation Capital (CIC).
Elypta AB has devised new multi-cancer early detection technology leveraging plasma and urine glycosaminoglycans which can detect more than a dozen types of cancer in adults showing no symptoms.
As companies increasingly use artificial intelligence (AI) in medical devices and applications to help treat and diagnose patients, innovators must be careful of excluding large sections of the population in their algorithms and in their data gathering process, delegates heard at the Medtech Futures conference in Cambridge, U.K.
Europe has given device makers more time to meet requirements set out in the 2017 Medical Devices Regulation (MDR). The European Parliament approved in mid-February an extension of the transition periods for medical device and IVD manufacturers to comply with the new rules, which aim to enhance safety for patients and ensure the “smooth functioning of the internal market.”
Visionhealth GmbH will use the €3 million (US$3.2 million) it recently raised in a pre-series A financing to conduct a clinical trial on its digital health app designed to provide more accurate dosing of treatments for chronic obstructive pulmonary disease (COPD) and asthma.
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