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BioWorld - Saturday, January 24, 2026
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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First-in-human data presented for ASP-5354

Oct. 21, 2020
Australia and coronavirus

Australia’s device and biotech companies hold the key for future pandemic preparedness: MTPConnect report

Oct. 20, 2020
By Tamra Sami
PERTH, Australia – During the COVID-19 pandemic, 90% of Australia’s clinical trials were put on hold, and the market cap of biotech and medical device companies on the Australian Securities Exchange dropped 5% to AU$11 billion (US$7.78 billion), according to a recent report by Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre.
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Doctor, technician look at computer while man undergoes MRI

FDA green lights Ezra's Prostate AI and Plexo system

Oct. 20, 2020
By Annette Boyle
The U.S. FDA cleared Ezra AI Inc.'s artificial intelligence (AI) system for prostate cancer and its cloud-based picture archiving and communication system (PACS) that enables radiologists to use the Prostate AI from their browser. The New York-based company’s Prostate AI is the first prostate-focused artificial intelligence system to gain clearance. The Prostate AI accurately quantifies prostate volume, lesion size, and renders 3D volumes of the prostate gland and lesions.
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Digital illustration of U.S., coronavirus

FDA iffy on whether labs should file EUA documentation despite agency’s no-review policy

Oct. 20, 2020
By Mark McCarty
The U.S. FDA’s device center has declared it will not review emergency use authorization (EUA) requests for lab-developed tests (LDTs) for the COVID-19 pandemic, but on the agency’s most recent town hall, on Oct. 14, FDA officials were uncertain as to whether labs should file those EUAs, leaving labs in a state of limbo yet again.
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Coronavirus, lungs, hand holding stethoscope

Nec partners with Oslo University Hospital to develop AI-based diagnostic for COVID-19

Oct. 16, 2020
By Elise Mak
Nec Corp.’s bioinformatics subsidiary Nec Oncoimmunity AS said it is working with Oslo University Hospital to develop an artificial intelligence (AI) platform that will allow the team to design a T-cell diagnostic to complement the current serological tests for infectious diseases, including COVID-19.
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BioWorld MedTech’s Diagnostics Extra for Oct. 15, 2020

Oct. 15, 2020
By Meg Bryant and Anette Breindl
Keeping you up to date on recent developments in diagnostics, including: Remote speech analysis detects early bulbar changes in ALS; Novel NGS approach captures both mtDNA mutation and copy number; Neutrophils are literal obstacle to stroke recovery.
Read More
Australia and coronavirus

Australia’s device and biotech companies hold the key for future pandemic preparedness: MTPConnect report

Oct. 15, 2020
By Tamra Sami
PERTH, Australia – During the COVID-19 pandemic, 90% of Australia’s clinical trials were put on hold, and the market cap of biotech and medical device companies on the Australian Securities Exchange dropped 5% to AU$11 billion (US$7.78 billion), according to a recent report by Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre.
Read More

Astellas describes discovery of novel PET probe for fatty acid oxidation

Oct. 15, 2020
Microscope image of SARS-CoV-2

Intervenn Biosciences IDs COVID-19 risk biomarkers using glycoproteomics

Oct. 13, 2020
By Meg Bryant
Intervenn Biosciences said it has identified stark differences in the glycoproteomic profile of COVID-19 patients who became very sick and people infected with the SARS-CoV-2 virus who were either asymptomatic or experienced only minimal effects. The contrast could help clinicians better understand the biological mechanisms of the disease and triage patients at risk of responding detrimentally to early treatments and more intensive care.
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Product packaging

Exact Sciences debuts Oncotype MAP pan-cancer tissue test

Oct. 12, 2020
By Meg Bryant
Time is of the essence when treating patients with advanced or metastatic cancer, and diagnostic insights can inform treatment plans. To that end, Exact Sciences Corp. has launched its Oncotype MAP Pan-Cancer Tissue test for patients with advanced, metastatic, refractory or recurrent cancer. From a small tissue sample, the test detects genomic alterations in hundreds of cancer-related genes, helping doctors better depict a patient’s tumor and recommend effective therapies or clinical trials.
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