Edwards Lifesciences Corp. said it has exercised its option to buy Innovalve Bio Medical Ltd., an early stage transcatheter mitral valve replacemen company, for $300 million in cash following its initial investment in 2017. Since that time, Edwards said Innovalve has demonstrated progress in its program with promising early clinical experience.

Roche Holdings AG received CE mark for its artificial intelligence (AI)-enabled continuous glucose monitoring (CGM) system, Accu-Chek Smartguide. The company said the solution addresses the unmet need around diabetes management and glycemic control as it offers critical predictions to people living with type 1 and type 2 diabetes.

Endoron Medical Ltd. raised $10 million in its series A funding round to accelerate clinical validation work on its catheter-based endostapling system, Aortoseal, which repairs abdominal aortic aneurysms. The round was led by Sofinnova Partners, with participation from the European Innovation Council Fund.

Smartcella Holding AB raised €50 million (US$54 million) in a new share issue that it will use to accelerate growth and ramp up commercialization of its endovascular Extroducer delivery device, in addition to strengthening its cell and mRNA operations. The funding is supported by existing and new investors including Astrazeneca, which committed to approximately half of the shares issued.

Researchers from the Wellcome Sanger Institute, and their collaborators at The Institute of Cancer Research, London and the University of Cambridge assessed the health impact of all possible genetic changes in the tumor protection gene, BRCA1-associated protein 1 gene.

Serac Imaging Systems Ltd. is seeing encouraging results from ongoing trials at three sites, which are comparing its Seracam portable hybrid gamma-optical camera for medical imaging to standard of care nuclear medicine imaging, Mark Rosser, CEO of the company, told BioWorld.

Syntheticmr AB received CE marking for its next-generation brain imaging solution, SyMRI Neuro. The company hopes that version 15 of its SyMRI software, which provides quantitative data, automatic tissue segmentation and adjustable contrast weighted images from a scan, will transform diagnostic imaging.

A trio of regulators devised a series of good machine learning practices in 2021, a key point of consideration for many algorithms that will eventually be used in thousands of medical applications in the coming years.

A new non-invasive device which enables women to test themselves at home for signs of the cancer-causing human papillomavirus strains in menstrual blood, has been developed with support from the Venture Builder Incubator at the University of Edinburgh.

Uromems SAS raised $47 million in a series C financing round for its Uroactive system, the first smart automated artificial urinary sphincter device to treat stress urinary incontinence. With the funds the company will be able to “tackle the last stage of our clinical trials before commercial launch,” Hamid Lamraoui, CEO and co-founder of Uromems, told BioWorld.