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BioWorld - Thursday, December 18, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Ultra-microcap Endra aims to launch affordable NAFLD/NASH diagnostic imaging tool in 2020

Dec. 4, 2019
By Stacy Lawrence
Ann Arbor, Mich.-based startup Endra Life Sciences Inc. started out focused on a photoacoustic imaging tool for mice in the lab, but in recent years it has shifted gears. Now, it aims to secure the go-ahead next year from European and U.S. regulators to launch a thermo-acoustic enhanced ultrasound system designed to quantitatively assess liver fat, known as TAEUS.
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Chinese yuan and piggy bank
Newco

China’s Genskey raised $14M in series B to advance pathogen testing

Dec. 4, 2019
By Elise Mak
BEIJING – Infection diagnostics specialist Genskey Technologies Co. Ltd., of Beijing, closed a series B financing round to secure ¥100 million (US$14 million) to advance pathogen testing using next generation sequencing. The series B round was joined by SB China Capital, Shanghai Lin Chong Investment Management, and Juyuan Capital.
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89Zr-DFO-MSTP-2109A shows promise as companion diagnostic in patients with mCRPC

Dec. 4, 2019
Righeye-system-12-3.png

Righteye wins breakthrough device designation for Parkinson’s test

Dec. 3, 2019
By Meg Bryant

The U.S. FDA has granted breakthrough device designation for Righteye LLC’s eye movement-tracking vision system as a test for Parkinson’s disease. Developed by researchers at PADRECC and Virginia Commonwealth University with funding from the Michael J. Fox Foundation, and licensed to Righteye in 2016, the test requires patients to sit in front of an all-in-one tablet-looking device and follow a series of moving targets. The goal is to identify ocular tremors, a persistent issue with Parkinson’s patients that prevents steady fixation on objects and images. The noninvasive test, which measures an individual’s ability to follow objects on a screen, could help doctors not only confirm the difficult-to-diagnose disease, but also detect it at earlier stages.


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U.S. flag, stethoscope

Stakeholders press CMS to allow repeat testing in do-over of NGS coverage memo

Dec. 2, 2019
By Mark McCarty
The Medicare coverage memo for next-generation DNA sequencing (NGS) was reopened to allow for NGS testing for other than late-stage cancers, but stakeholders are urging the U.S. Centers for Medicare and Medicaid Services (CMS) to allow repeat testing, another change that would considerably boost utilization.
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MRI film

AI-based diagnostics company Neurophet secures ₩6 billion in series A

Dec. 2, 2019
By Jihyun Kim
HONG KONG – Neurophet Inc., a South Korean AI-based brain disease diagnostics company, has secured ₩6 billion (US$5.1 million) in series A funding. The med-tech startup produces solutions based on Segengine, the company’s own technology that automatically segments brain magnetic resonance (MR) images into 107 regions within a minute.
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First-in-human study of 89Zr-DFO-REGN-3504 for imaging PD-L1 tumors

Nov. 29, 2019
Coins and seedling

Lucence attracts $20M in series A to scale up operations

Nov. 26, 2019
By Jihyun Kim
HONG KONG – Lucence Diagnostics Pte Ltd., a genomic medicine company headquartered in Singapore, has secured $20 million in series A investment.
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APRINOIA Therapeutics describes compounds targeting microtubule-associated protein tau

Nov. 26, 2019
DNA illustration

Asuragen to develop CDx for Huntington’s disease gene therapies

Nov. 25, 2019
By Meg Bryant
Huntington’s disease is a fatal hereditary disease that results in the progressive breakdown of nerve cells in the brain. It erodes a person’s physical and mental abilities, usually beginning in their 30s and 40s, and to date has no cure. Now Austin-based Asuragen Inc. is joining forces with Wave Life Sciences USA Inc., of Cambridge, Mass., to develop companion diagnostics (CDx) for Wave’s investigative allele-selective therapeutic programs targeting the genetic cause of the disease.
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