I-calQ receives 9th patent for smartphone POC testing

LabPulse.com staff writers
Jan 14, 2021
2020 03 04 00 35 9478 Smartphone Hands 400

Diagnostic developer I-calQ has received a ninth patent for its point-of-care (POC) testing technology, which can be used with most smartphones and can test for potentially hundreds of analytes or agents.

I-calQ's technology uses the smartphone as a processor. Its camera is used to read a disposable test strip cassette, and a proprietary app that analyzes, calibrates, and quantifies results in about 10 minutes. It also has the ability to upload the data immediately.

The firm has already developed tests for thyroid stimulating hormone (TSH), hemoglobin, and cortisol, and it is adding infectious diseases to its repertoire. The company has two tests with CE Marks and one test pending U.S. Food and Drug Administration (FDA) submission.

Latest in FDA Submission
Influenza Virus Social
CorDx submits EUA application for COVID-19/influenza rapid test
February 10, 2024
Fda Sign Dc Social
NowDiagnostics submits FDA de novo request for OTC syphilis test
January 10, 2024
Visit our Molecular Diagnostics Community
Sponsored
Visit our Molecular Diagnostics Community
April 5, 2024
Fda Sign Dc Social
Vertex Pharmaceuticals, CRISPR Therapeutics gene-editing therapy to undergo FDA advisory committee review
October 30, 2023
Related Stories
2020 04 15 22 01 4693 Abbott Architect 400
FDA Submission
Abbott unveils lab-based COVID-19 antibody blood test
2016 09 02 09 36 05 93 Fda Logo V2 400
FDA Submission
FDA moves to electronic-only device submissions
2019 02 13 19 24 5396 Fda Logo V2 400
FDA Submission
FDA airs 'to do' list for devices in 2020
More in FDA Submission
CorDx submits EUA application for COVID-19/influenza rapid test
By LabPulse.com staff writers
CorDx has submitted an Emergency Use Authorization (EUA) application for its CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test to the U.S. Food and Drug Administration (FDA).
February 10, 2024
Influenza Virus Social
NowDiagnostics submits FDA de novo request for OTC syphilis test
By LabPulse.com staff writers
NowDiagnostics has submitted a de novo authorization request to the U.S. Food and Drug Administration (FDA) for its First to Know over-the-counter (OTC) syphilis test.
January 10, 2024
Fda Sign Dc Social
FDA grants priority review to Merck’s pneumococcal vaccine
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted priority review to Merck’s experimental pneumococcal vaccine, with a decision to be made on approval by June 17, 2024.
December 20, 2023
Vaccine Injection Social
Vertex Pharmaceuticals, CRISPR Therapeutics gene-editing therapy to undergo FDA advisory committee review
By LabPulse.com staff writers
An FDA advisory committee is scheduled to meet on October 31 to discuss and make recommendations on Vertex Pharmaceuticals' and CRISPR Therapeutics’ CRISPR-Cas9 gene-editing-based therapy, exagamglogene autotemcel.
October 30, 2023
Fda Sign Dc Social
GeninCode files pre-market notification with FDA for cardiovascular risk assessment test
By LabPulse.com staff writers
The filing is part of GeninCode’s effort to expand its U.S. commercial distribution of CIC-SCORE; the company filed its pre-submission for GeninCode with the FDA last year.
August 18, 2023
Heart Hologram Virtual Social
OIG: FDA recommendations for future pandemics
By Leo O'Connor
OIG offered numerous recommendations to manage such infectious disease emergencies, saying the FDA should access and, when appropriate, revise its guidance for Emergency Use Authorization (EUA) submissions for tests.
September 21, 2022
2021 11 29 23 50 3003 Fda Button 20211129235739
Cue Health requests FDA de novo clearance for at-home flu test
By LabPulse.com staff writers
Clearance would permit the test to be used at home and elsewhere at the point-of-care (POC).
September 1, 2022
2022 09 02 19 52 9683 Flu Season Ahead 400
FDA issues updated reagent, instrument guidance
By LabPulse.com staff writers
The agency said that it revised the current guidance to include point-of-care in vitro diagnostic (IVD) devices in certain situations, flowcharts, updates to examples, and further clarification of terminology.
August 15, 2022
2021 11 29 23 50 3003 Fda Button 20211129235739
Natera files presubmission with FDA for NIPT test
By LabPulse.com staff writers
According to the FDA, Q-Subs can serve as helpful tools in the premarket submission process.
August 10, 2022
2019 10 09 23 45 4810 Lab Nipt Test 400
Abionic nabs IVDR certification for sepsis test
By LabPulse.com staff writers
The device detects pancreatic stone protein, an early marker for sepsis, allowing for its identification in about five minutes, Abionic said.
August 8, 2022
2020 06 19 20 57 0712 Sepsis Bacteria 400
MDIC releases IVD regulatory decision-making framework
By LabPulse.com staff writers
The framework is designed to help the IVD industry and the U.S. Food and Drug Administration (FDA) better incorporate real-world data into development and regulatory decisions for IVD products. It also outlines the designs and statistical methods needed in order to generate real-world evidence for regulatory submissions.
August 23, 2020
2019 07 26 20 46 7792 Lab Blood Woman 400
HHS: FDA review not needed for coronavirus LDTs
By Brian Casey
In the guidance, the HHS said that the FDA will not require labs to go through premarket review of LDTs for COVID-19 before they can be used on patients. Labs can choose to seek emergency use authorization (EUA) from the FDA if they wish, and the agency will adjudicate these submissions.
August 19, 2020
2020 01 27 21 38 4451 Lab 2019 Coronavirus Test 400
Page 1 of 2
Next Page