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Home » Authors » Shani Alexander

Articles by Shani Alexander

Albus Health device Albus Home

Albus device detects asthma attacks 5 days early

Dec. 2, 2024
By Shani Alexander
An artificial intelligence-powered contactless monitoring device developed by Albus Health Ltd. can detect signs of asthma attacks in children up to five days before they occur.
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Myval Octapro THV
Conference: PCR London Valves

Meril launches new valve amid patent infringement fight in Europe

Nov. 27, 2024
By Shani Alexander
Meril Life Sciences Pvt Ltd. recently launched its next generation transcatheter heart valve (THV), the Myval Octapro THV, which it says allows for better operator control for precise positioning and improved predictability in implantation. The new valve comes however, as the company battles with Edwards Lifesciences Corp. in a European court over patent infringement of its technology.
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3D rendering of heart, mitral valve
PCR London Valves

TMVR technologies coming, but challenges remain

Nov. 26, 2024
By Shani Alexander
Although there is a clear clinical need for transcatheter mitral valve replacement technologies, a number of challenges must be overcome before they can safely be used to treat patients with mitral regurgitation. Nevertheless, two new devices could enter the European market next year, Edwards Lifesciences Corp.’s Sapien M3 and Highlife Medical SAS’s Highlife TMVR device.
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Device in heart

Edwards reveals superior outcomes with Sapien 3 Ultra Resilia

Nov. 25, 2024
By Shani Alexander
Edwards Lifesciences Corp. revealed excellent one-year data highlighting the performance of its newest generation Sapien 3 Ultra Resilia valve. Patients treated with the transcatheter aortic valve replacement system experienced lower rates of mortality and reintervention compared to its predecessors.
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Ultromics

Ultromics’ AI software for cardiac amyloidosis gets FDA approval

Nov. 22, 2024
By Shani Alexander
Ultromics Ltd. received clearance from the U.S. FDA for Echogo Amyloidosis, its artificial intelligence-enhanced software that helps with the early diagnosis of cardiac amyloidosis, enabling timely intervention that can significantly improve patients' quality of life and extend survival.
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BrightHeart software

Brightheart secures FDA clearance for software to detect fetal heart defects

Nov. 21, 2024
By Shani Alexander
The U.S. FDA granted Brightheart SAS 510(k) clearance for its artificial intelligence software which helps doctors detect congenital heart defects in fetuses. The software will transform prenatal ultrasound evaluations of the fetal heart and improve the outcomes for newborns, Cécile Dupont, Brightheart’s CEO, told BioWorld.
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Devyser One-Lambda cfDNA

Devyser to democratize NGS test, seek US FDA approval

Nov. 20, 2024
By Shani Alexander
The recent agreement between Devyser Diagnostics AB and Thermo Fisher Scientific Inc. to collaborate to obtain U.S. FDA approval for a next-generation sequencing (NGS) test for kidney transplant monitoring allows the test to be democratized, Fredrik Alpsten, CEO of Devyser to BioWorld.
Read More
NHS building

Data, med tech and science to transform the NHS

Nov. 20, 2024
By Shani Alexander
The U.K. Secretary of State for Health and Social Care, Wes Streeting, says that he wants people to see the national health service as a neighborhood health service as he works towards reimagining the health system and bringing care into people's homes. Data, he said, will be at the heart of the transformation. So too will be the deployment of science and medical technologies.
Read More
Money sack with British pound symbol

​Investors and corporates bullish about 2025, Jefferies says

Nov. 18, 2024
By Shani Alexander
Investors and corporates in health care are optimistic going into 2025 as they believe that capital constraints in the sector are finally easing, according to a report by global investment bank Jefferies. The return of the IPO market and increased M&A activity contributed to an uptick in confidence in the sector.
Read More
Heart, DNA and ECG

Smartcardia’s ECG patch gains FDA nod for outpatient cardiac telemetry

Nov. 18, 2024
By Shani Alexander
Smartcardia SA received U.S. FDA clearance for mobile outpatient cardiac telemetry for its seven-lead live ECG monitoring patch and cloud platform. With the approval, the solution can now be used for remote live monitoring of a patient’s ECG and immediately notify clinicians in cases of arrhythmias.
Read More
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