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Home » Authors » Shani Alexander

Shani Alexander

Articles

ARTICLES

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.
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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.
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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.
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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.
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Endoflip system with display and catheter

​Medtronic receives CE mark for next generation Endoflip system​

Nov. 15, 2024
By Shani Alexander
Medtronic plc obtained a CE mark for its next generation Endoflip 300 system which measures pressure and dimensions in the esophagus and pylorus, in adults. The Endoflip can be used to help diagnose and treat thousands of people across Europe suffering with esophageal motility disorders.
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Liver over digital lens background

Organox and Egenesis sign agreement for liver support system

Nov. 14, 2024
By Shani Alexander
Organox Ltd. and Egenesis Inc. signed an agreement to advance a liver support system to facilitate liver recovery in the acute setting.
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3D illustration of transparent human torso with close up of spinal cord

Nevro wins CE mark for spinal cord stimulation technology

Nov. 13, 2024
By Shani Alexander
Nevro Corp. received CE mark certification for its HFX iQ spinal cord stimulation system that delivers pain relief.
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Momentis Surgical Anovo robotic platform

Momentis gains FDA clearance for second generation surgical robot

Nov. 12, 2024
By Shani Alexander
Momentis Surgical Ltd. received 510 (k) clearance from the U.S. FDA for the second-generation of the Anovo robotic surgical platform. The upgraded system allows surgeons to experience enhanced ergonomics with integrated haptic feedback, creating more intuitive control of the robotic arms during surgical procedures.
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Hyperfine Research - swoop

Hyperfine gains CE mark for MRI brain imaging software

Nov. 11, 2024
By Shani Alexander
Hyperfine Inc. gained CE mark approval for the latest generation of its artificial intelligence-powered software for its Swoop portable magnetic resonance imaging system, under the European Medical Device Regulation.
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iFAST
Infection

Ifast raises $6.5M for technology to fight antimicrobial resistance​

Nov. 11, 2024
By Shani Alexander
Ifast Diagnostics Ltd. raised $6.5 million (£5 million) in seed funding to bring its rapid Antimicrobial Susceptibility Testing (AST) platform to the market. The company’s technology is vital in the fight against antimicrobial resistance and the funds will be used to conduct clinical trials to get the product to the market in the U.K., U.S. and EU, CEO Toby King, told BioWorld.
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View All Articles by Shani Alexander

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