The U.S. FDA 510(k) clearance of Airamed GmbH’s Airascore software could see millions of people benefitting from early accurate diagnosis of Alzheimer’s disease and other types of dementia. Airascore is a medical image management and processing system that uses deep learning and artificial intelligence (AI) to assess brain volumetry data on MRI scans in as little as five minutes.
Rhythm Diagnostic Systems SA (RDS) received €1 million (US$1.1 million) from Capital Grand Est, the first venture capital (VC) firm to join its investor pool, taking its total seed capital raised to €13 million. RDS will use the funds to progress toward the next stages in the development of its Multisense product, a remote patient monitoring solution, including market launch, once it receives CE mark from the European authorities expected by the end of the year.
Inbrain Neuroelectronics SL was granted a breakthrough device designation from the U.S. FDA for its graphene-based neural platform as an adjunctive therapy for treating Parkinson’s disease. The platform, called intelligent network modulation system, harnesses the power of graphene and artificial intelligence to deliver highly focused, adaptive neuroelectronic therapy that re-balances pathological neural networks, easing the symptoms of Parkinson’s.
Dexcom Inc. revealed new clinical data at the European Association for the Study of Diabetes (EASD) which highlighted the benefits of the use of continuous glucose monitoring (CGM). Results from the COMISAIR seven-year study, the longest prospective real-world CGM trial ever conducted, showed significant and continued reduction of HbA1c with the use of real-time CGM by people with type 1 diabetes.
The U.K. has launched the first-of-its-kind national total-body positron emission tomography (PET) imaging platform that will be ‘game-changing’ for clinical research. Funded with £32 million (US$39 million) from the government, the National PET Imaging Platform (NPIP) will enable clinicians and researchers to access never-before-seen data that will improve the detection, diagnosis and treatment of complex, multi-organ diseases.
Boston Scientific Corp.’s plan to acquire Relievant Medsystems Inc. is part of its ongoing effort to address chronic pain which is significantly impacting the quality of life of millions of people. Relievant’s Intracept intraosseous nerve ablation system will give Boston Scientific another tool in its armory to tackle chronic pain which already includes radiofrequency ablation (RFA) solutions and spinal cord stimulator (SCS) systems.
The receipt of a reimbursement code for the Episwitch Prostate Screening (PSE) test developed by Oxford Biodynamics plc, following its recent launch, is good news for men frustrated with the inaccuracies in prostate-specific antigen (PSA) tests and the lack of alternatives, Jon Burrows, CEO of Oxford Biodynamics told BioWorld.
Following the receipt of a U.K. Conformity Assessed (UKCA) mark for its kidney function diagnostic software, the CKD Screening Prioritizer (CSP), Gendius Ltd. is hoping to soon receive CE mark and then U.S. FDA approval next year. Given that people with type 2 diabetes are at a higher risk of developing chronic kidney disease, Gendius’ pre-screening software will be “transformative” for patients and health care systems, CEO Rory Cameron told BioWorld in an interview.
Enovis Corp. has agreed to acquire Limacorporate S.p.A. (Lima) from EQT Capital for €800 million (US$847 million) as part of its growth strategy that will see it achieve $2 billion in revenues by 2024. The transaction includes €700 million in cash and €100 million in shares of Enovis common stock, expected to be issued within 18 months after closing.
In another boost to its diabetes portfolio, Medtronic plc was granted CE mark approval for its Simplera continuous glucose monitor (CGM) sensor. The EU greenlight for Simplera follows the U.S. FDA approval for Medronic’s Minimed 780G insulin pump system earlier in the year. Simplera is an all-in-one disposable CGM sensor which features a two-step insertion process and will help patients who must have multiple daily injections (MDI) manage their diabetes.
