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Home » Authors » Shani Alexander

Articles by Shani Alexander

Amber Therapeutics Picostim system

Amber Therapeutics raises $100M for bio e-stim for urinary incontinence therapy

June 10, 2024
By Shani Alexander
Amber Therapeutics Ltd. has raised $100 million in a series A funding round to further develop its implantable closed-loop bioelectrical therapy to treat women suffering from mixed urinary incontinence. The financing is one of the largest series A rounds ever seen in Europe’s medical technology space and comes at a time when many med-tech companies are struggling to raise funds.
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Moon Surgical Maestro

Moon Surgical gets FDA clearance for surgical robotic system

June 7, 2024
By Shani Alexander
Moon Surgical SAS recently received U.S. FDA clearance for the commercial version of its Maestro surgical robotic system for laparoscopic procedures. The greenlight is “pretty massive” for the company as it will allow the robotic platform to be rolled out in the U.S., to help enhance the surgeon’s performance while carrying out procedures, Anne Osdoit, CEO of Moon Surgical, told BioWorld.
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ITM Mode-of-Action

ITM raises €188M for radiopharmaceutical pipeline

June 6, 2024
By Shani Alexander
Isotope Technologies Munich SE (ITM) raised €188 million ($204 million) in a funding round that will largely be used to advance and expand the company’s radiopharmaceutical pipeline. The funds, which come a year after ITM raised €255 million, are a sign of growing investor interest in the company’s products and the radiopharma market, Steffen Schuster, CEO of ITM, told BioWorld.
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aXess vascular access conduit

Xeltis vascular access graft may transform patient lives

June 5, 2024
By Shani Alexander
Xeltis BV hopes that promising data from clinical trials on the performance of its synthetic vascular access graft implant will transform not only the lives of patients suffering from chronic kidney disease but also the company’s fortunes. “We're outperforming other solutions out there, that's the nice promise not only for the patient and for the families but also for potential strategics that might be interested in the company and play a role in the vascular space,” Eliane Schutte, CEO of Xeltis told BioWorld.
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En Carta casette

En Carta raises funds for diagnostic test for early Lyme disease

June 4, 2024
By Shani Alexander
The €1.5 million ($US1.63 million) in pre-seed funding recently raised by En Carta Diagnostics SA is “key” for the company to be able to develop its point-of-care molecular diagnostics kits and generate clinical data, Guillaume Horreard, CEO at En Carta told BioWorld.
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Therasphere Y-90 glass microspheres

NICE: Radioembolization treatment for neuroendocrine liver cancer

June 3, 2024
By Shani Alexander
The U.K.’s National Institute for Health and Care Excellence recent recommendation that selective internal radiation therapy could be used to treat neuroendocrine tumors that have metastasized to the liver is a boon for patients suffering from the disease. However, there is not yet a clear pathway for these patients to receive the therapy via the national health service.
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Stereotaxis robotic magnetic navigation (RMN) system

Stereotaxis receives CE mark certification for devices in Europe

May 31, 2024
By Shani Alexander
Stereotaxis Inc. recently received CE mark recertification for all its devices currently available in Europe under the new Medical Device Regulation (MDR) regulatory framework. The MDR has replaced the European Medical Device Directive and includes more stringent standards but meeting the new requirements comes with frustrations and costs for many companies.
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Conceptual image for brain cancer treatment

Urteste develops urine-based diagnostic test for detecting brain tumors

May 30, 2024
By Shani Alexander
Urteste S.A. has developed a urine-based diagnostic test for the early detection of brain tumors. The prototype, which can detect the activity of brain-specific enzymes in urine, is a breakthrough test and the first solution of this type in the world, Grzegorz Stefański, CEO and co-founder of Urteste S.A., told BioWorld.
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Camaps FX closed loop system

FDA approves first algorithm for use in pregnant women with type 1 diabetes

May 29, 2024
By Shani Alexander
The U.S FDA approved Camaps FX for use in pregnant women with type 1 diabetes. This first, hybrid, closed-loop app was developed by Camdiab Ltd., a spinout from Cambridge University, allows individuals aged two years and older with type 1 diabetes to manage their glucose levels.
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Volta AF-Xplorer

​Volta sees positive results for AI companion device to treat atrial fibrillation​

May 24, 2024
By Shani Alexander
Volta Medical SAS reported positive results from the Tailored-AF study which compared its artificial intelligence software-guided ablation procedure in combination with pulmonary vein isolation to a conventional anatomical ablation targeting PVI alone, to treat persistent atrial fibrillation.
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