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Home » Authors » Shani Alexander

Articles by Shani Alexander

All of Us illustration
LSX World Congress

Collaboration, data key to precision medicine transforming med-tech

April 30, 2024
By Shani Alexander
Precision medicine holds exciting promise for the medical device industry as it offers a range of solutions within diagnostics, digital devices and imaging, which could transform patient care, delegates heard at the LSX World Congress in London. However, there are a range of challenges ahead, including the population of clinical data, getting past the inertia of physicians and making it easier to run clinical studies.
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FDA approved icons and medical professional
LSX World Congress

Integra will not launch any product in the EU before the US

April 29, 2024
By Shani Alexander
Integra Lifesciences Holdings Corp. will not launch any new product in the EU before the U.S. because of the challenging requirements under the new Medical Device Regulation, Stuart Hart, chief medical officer at the Princeton, New Jersey-based company, told delegates at the LSX conference in London.
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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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