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BioWorld - Sunday, July 12, 2026
Home » Topics » Medical technology » Diagnostics

Diagnostics
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Deep Bio wins CE marking of AI-based prostate diagnosis software

Nov. 18, 2019
By Jihyun Kim
HONG KONG – South Korean biotech Deep Bio Inc. has won CE marking for its artificial intelligence (AI)-powered medical software DeepDx-Prostate Connect.
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BioWorld MedTech's Diagnostics Extra

Nov. 15, 2019
By Meg Bryant and Anette Breindl
Keeping you up to date on recent developments in diagnostics.
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Scanwell Health aims to ease testing for UTIs with smartphone-enabled option

Nov. 15, 2019
By Liz Hollis
Urinary tract infections (UTIs) are a common reason for women to visit their doctor. While virtual doctor visits have been possible to detect UTIs, patient-reported symptoms typically have drove diagnoses. Now, Los Angeles-based Scanwell Health is bringing its at-home smartphone-enabled test and treatment service for UTIs to all 50 states. Scanwell said its offering its the first U.S. FDA-cleared urine testing app available over-the-counter without a prescription.
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Wyss Institute researchers develop hand-held rapid diagnostics technology

Nov. 15, 2019
By Stacy Lawrence
Hand-held diagnostics don't come cheaply, and their applications remain somewhat limited. Abbott Laboratories' Istat portable clinical analyzer, for example, retails at about $15,000, with each individual cartridge costing hundreds of dollars apiece to measure each of roughly a few dozen blood gas, electrolyte, chemistry and hematology levels in few minutes from two to three drops of whole blood.
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Cerveau Technologies starts Japanese phase I study of [18F]MK-6240

Nov. 15, 2019
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Philips launches its first AI-based cognitive assessment product in the U.S.

Nov. 14, 2019
By Stacy Lawrence
A neuropsychologist consult is typically the first step for a neurologist in aiding in the diagnosis and monitoring of neurological conditions. But timely appointments for an assessment by these specialists can be difficult to obtain, even under the best of circumstances. To better enable neurologists to assess which patients are most in need of a consultation with a neuropsychologist, Royal Philips NV has launched an artificial intelligence (AI)-based cognitive assessment tool in the U.S. Known as Philips Intellispace Cognition, the digital, cloud-based assessment tool takes established neuropsychological tests and enables their administration by a medical assistant via a tablet in an office setting.
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Following solid quarterly results, Hologic gains FDA nod for 3Dquorum imaging tech

Nov. 13, 2019
By Liz Hollis
Marlborough, Mass.-based Hologic Inc. got good news from the U.S. FDA, which has given the green light for the 3Dquorum imaging technology, which employs Genius AI. The technology works along with Hologic's Clarity HD high-resolution imaging technology to reduce tomosynthesis image volume for radiologists by 66%, the company said.
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DNA

FDA clears first whole exome sequencing platform for overall tumor mutation burden

Nov. 13, 2019
By Meg Bryant
Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite.
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FDA clears first whole exome sequencing platform for overall tumor mutation burden

Nov. 13, 2019
By Meg Bryant
Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite.
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AASLD 2019

With NASH drugs on cusp of arrival, noninvasive diagnostics are the 'second pillar of need'

Nov. 12, 2019
By Anette Breindl
BOSTON – For diagnosing nonalcoholic steatohepatitis (NASH), liver biopsy is "the reference standard," Dean Hum, president of Genfit Corp., told BioWorld MedTech. "I'm not going to call it the gold standard."
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