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.

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.

The U.S. FDA granted Signum Surgical Ltd. de novo marketing clearance for its Biohealx technology as a treatment for anal fistula. Biohealx is a single use, bioabsorbable implant, designed to not only to treat the condition in a minimally invasive procedure but also promote healing, prevent fistula recurrence and protect patient continence.

Alcon AG completed the acquisition of Belkin Vision Ltd. with an upfront consideration of $81 million with an additional $385 million in contingent payments. With the deal, Alcon gets its hands on Belkin’s U.S. FDA-cleared direct selective laser trabeculoplasty device, expanding its treatment options for patients with glaucoma.

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 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.

Femasys Inc. received CE mark for four women’s health products – Femaseed, Femvue, Femcerv and Femcath – after obtaining certification under the EU Medical Device Regulation. This allows the company to expand its market reach and it will now focus on delivering its innovative solutions for women’s reproductive health within the EU.