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Home » Authors » Shani Alexander

Shani Alexander

Articles

ARTICLES

Front Line cobra-os

Front Line granted CE mark for smallest aortic occlusion device

April 26, 2024
By Shani Alexander
Front Line Medical Technologies Inc. recently received CE mark for its Cobra-OS, the smallest REBOA (resuscitative endovascular balloon occlusion of the aorta) device for use in emergency situations on the market. The company believes that Cobra-OS could help save the lives of patients during traumatic bleeding situations as it could buy valuable time until definitive care can be provided.
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Hand holding dollar sign on yellow background

Owlstone gets $6.5M from Gates Foundation for breath-based diagnostics

April 25, 2024
By Shani Alexander
Owlstone Medical Ltd. received $6.5 million in funding from the Bill & Melinda Gates Foundation which will go towards expanding its Breath Biopsy platform as well as developing breath-based diagnostic tests to identify breath biomarkers for tuberculosis and HIV.
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Cancer cell illustration

New method for analyzing cancer cells could unlock targeted treatments

April 24, 2024
By Shani Alexander
Researchers have developed and validated a new technique that allows them to measure the lipid compounds in live cancer cells, one by one, according to a study published in the journal Analytical Chemistry. The new method paves the way for analyzing cells in greater detail to better understand infection, immunity and other phenomena, and could lead to the development of new, more targeted treatments.
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Artistic rendering of deep brain stimulation.

Neurovalens gets FDA nod for neurostimulator to treat anxiety

April 23, 2024
By Shani Alexander
Neurovalens Ltd recently received U.S. FDA clearance for its Modius Stress device, a neurostimulator that treats people suffering from generalized anxiety disorder (GAD). It also closed a £2.1 million (US$2.65 million) funding round and is planning to raise up to $50 million in a series B fundraising round to be launched later this year.
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Smart Reporting software

Smart Reporting raises €23M for medical software

April 22, 2024
By Shani Alexander
Smart Reporting GmbH raised €23 million (US$24.5 million) in a series C funding round for its medical reporting software which automates and streamlines physicians’ workload. The funding is a “significant accelerator” for the company, “catalyzing business growth, product development, and expansion into international markets,” Wieland Sommer, founder and co-CEO of Smart Reporting told BioWorld.
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British flag

UK taking steps to boost adoption of med tech at the NHS

April 19, 2024
By Shani Alexander
The U.K. government said it is taking active steps to ensure that the country’s health and social care system can reliably access safe, effective and innovative technologies. One year following its inaugural medical technology strategy, the government reported changes underway which have already transformed the med-tech sector and consequently patients’ lives.
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Bone marrow illustration with doctor background

Scopio wins FDA clearance for bone marrow aspirate application

April 18, 2024
By Shani Alexander
The U.S. FDA granted Scopio Labs Ltd. de novo clearance for its artificial intelligence (AI)-powered software which analyzes bone marrow. Scopio’s Full-Field Bone Marrow Aspirate (FF-BMA) system aims to improve patient care by standardizing bone marrow aspirate analysis and elevating diagnostic precision.
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Ingenion Medical Cymactive 2

Ingenion receives CE mark for Cymactive urinary catheter

April 17, 2024
By Shani Alexander
Ingenion Medical Ltd. received a CE mark for its Cymactive 2.0R urinary catheter, a device to treat men suffering from chronic, non-neurogenic urinary retention. The technology, designed to mimic natural urination, will “transform” the lives of men currently struggling with the challenges of using Foley-type catheters, Edward Cappabianca, CEO of Ingenion Medical told BioWorld.
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Illustration of cryoblation procedure in breast

Icecure seeks FDA authorization to market cryoablation system for breast cancer

April 16, 2024
By Shani Alexander
Icecure Medical Ltd. submitted data to the U.S. FDA seeking de novo marketing authorization for its Prosense system to treat patients with early stage T1 invasive breast cancer in combination with adjuvant hormone therapy. Prosense is a minimally invasive cryoablation technology that freezes and destroys tumors, both malignant and benign.
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Neurons with dendrites affected by amyloid plaques in Alzheimer's disease

Roche, Eli Lilly Alzheimer's blood test granted breakthrough device designation

April 15, 2024
By Shani Alexander
The U.S. FDA granted Roche Holding AG breakthrough device designation for the Elecsys pTau217 assay that it is developing with Eli Lilly and Co. The test will help with the earlier diagnosis of Alzheimer's disease as it will be able to identify pTau217, a phosphorylated fragment of the protein tau, which is a biomarker that can distinguish the disease from other neurodegenerative disorders.
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