Rhythm Diagnostic Systems SAS (RDS) raised €14 million (US$16.6 million) in a series A funding round for Multisense, its wearable device that continuously monitors key physiological parameters of patients in hospital or at home. Already CE-marked and deployed in approximately 15 hospitals across France, Belgium and Germany, the funds will enable RDS to expand its commercial and customer support teams and prepare reimbursement filings in key European markets, Elie Lobel, CEO of RDS, told >BioWorld.
Kent Imaging Inc. received CE marking for its SnapshotNIR imaging device which uses near-infrared spectroscopy to measure oxygenated and deoxygenated hemoglobin in the microvasculature. The non-invasive point-of-care device provides real-time data to clinicians to help them make decisions which can change the trajectory of a wound, from chronic and non-healing, into a healing one, significantly improving the patient’s quality of life.
Convatec Group plc secured CE mark and UKCA approvals for Convamatrix, its porcine placenta-based wound dressing designed for hard-to-heal wounds. The single use, skin substitute product is intended to cover, protect and provide a moist wound environment to support the body’s natural healing process.
Quantum Surgical SAS has secured CE marking for the expanded use of its Epione robotic platform to treat bone tumors and metastases. The regulatory green light allows surgeons to use Epione to treat inoperable tumors which are difficult to reach due to their size or location at an early stage, in a simple and effective way.
Medtronic plc expects its Hugo robotic-assisted surgery system to be a key growth driver, especially when it receives U.S. FDA approval. Already approved for use in Europe, Medtronic recently received CE mark for the Ligasure technology to be used with the Hugo RAS system, expanding its capabilities for gynecologic, general and urologic procedures, across the region.
Anaconda Biomed SL recently received CE mark for the Ana5 funnel catheter, designed to improve mechanical thrombectomy in the treatment of acute ischemic stroke. The company hopes that the device, which has a vessel-matching diameter funnel to maximize the capture of blood clots, could be the holy grail in mechanical thrombectomy.
Newel Health srl received CE mark certification under the European Medical Device Regulation for Amicomed, its digital therapeutic solution for hypertension management. The app, which was cleared as a class IIa medical device, provides clinical insights and behavioral tools to help individuals manage their blood pressure.
Abbott Laboratories recently received FDA clearance for Tendyne, its transcatheter mitral valve replacement system. The news comes on the heels of Edwards Lifesciences Corp. securing a CE mark for its Sapien M3 system and is a boon for mitral valve therapies amid ongoing frustrations about the slow adoption of TMVR technologies.
Vivasure Medical Ltd. received CE mark approval for its Perqseal Elite vascular closure system which manages bleeding complications associated with large-bore arterial vessel closure. The sutureless, fully bioresorbable device has the potential to reduce problems associated with traditional closure methods in patients undergoing complex structural heart procedures.
Receipt of EU MDR CE mark may not be a magic potion, but Elixir Medical Corp. is certainly feeling a boost from the regulatory nod for its mechanical Lithix hertz contact intravascular lithotripsy system for treatment of moderate to severely calcified coronary artery lesions. Simultaneously, the company reported the launch of Lithix and completion of first cases in Italy, France and Germany.
