510(k): Page 5

Scopio introduces full-field PBS application
By LabPulse.com staff writers
Designed for hematology labs, the new application features adaptive monolayer identification for analysis. It supports short and long smears, white blood cell detection, preclassification and quantification into 16 classes, red blood cell morphology evaluation from 1,000 fields of view, and automated platelet location and preestimation, the company said.
September 26, 2021
2021 09 27 23 56 1469 2021 09 27 Scopio Labs Digital Imaging 400
FDA clears 1st prostate pathology AI software application
By Erik L. Ridley
Designed to serve as an adjunct to pathologist review of digitized prostate biopsy images, Paige Prostate identifies areas of interest on the images that contain the highest likelihood of cancer. Pathologists can then further review the AI findings if they had not identified these areas of concern on their initial evaluation, according to the FDA.
September 20, 2021
2019 02 13 19 24 5396 Fda Logo V2 400
LumiraDx launches COVID surveillance test in U.S.
By LabPulse.com staff writers
The company said its SARS-CoV-2 antigen surveillance test can test up to five samples simultaneously and deliver results in less than 12 minutes.
September 2, 2021
2021 01 11 17 03 4617 Covid Diagnostic Test Kit 400
Techcyte secures $21M in funding
By LabPulse.com staff writers
As part of this effort, the company will use the cash to complete necessary market clearance applications to the U.S. Food and Drug Administration (FDA), it said.
August 22, 2021
2019 05 08 21 57 5547 Pathology Digital Workstation 400
COVID-19 tests attempt to prove at-home testing concept can work
By Daniel Granderson
These COVID-19 tests were granted separate emergency use authorizations (EUAs) from the U.S. Food and Drug Administration (FDA) earlier in 2021 and all require nasal swab specimens from patients.
August 22, 2021
2021 08 18 22 53 0531 Covid 19 Self Swab Test 400
Alverno will deploy Ibex's AI software
By LabPulse.com staff writers
Ibex received breakthrough device approval from the U.S. Food and Drug Administration for the Galen software in June. The application is designed to improve the quality of cancer diagnosis, implement real-time quality control, reduce diagnosis time, and boost productivity, the companies said.
August 11, 2021
2020 07 27 23 48 6689 2020 07 27 Ibex Dig Path 400
Perspectum and Paige partner up to improve workflow in trials
By LabPulse.com staff writers
The partnership will bring together Perspectum's digital pathology service and integrated repository platform for both noninvasive and histology datasets and Paige's digital pathology software platform and software tools, the companies said.
August 5, 2021
2020 07 02 23 31 0378 Handshake Meeting 400
Promega's OncoMate MSI system cleared by FDA
By LabPulse.com staff writers
With the FDA clearance, the company said oncologists and pathologists in the U.S. can now access the IVD test that screens for Lynch syndrome in patients with colorectal cancer.
July 29, 2021
2019 05 22 19 44 5254 Dna Red Laser 400
NYU Langone genetic cancer test gets FDA 510(k) clearance
By LabPulse.com staff writers
Using next-generation sequencing, the test detects the DNA code changes of 607 genes linked by past studies to the development of multiple types of cancer, according to the institution. It matches the genetics of each patient's tumor cells with approved therapies targeted to specific sets of cancer-causing DNA changes, NYU Langone said.
July 28, 2021
2019 04 27 00 03 6781 Dna Sequence Shadow 400
Bio-Rad partners with Seegene
By LabPulse.com staff writers
Seegene will provide diagnostic tests for use on Bio-Rad's CFX96 Dx polymerase chain reaction (PCR) detection system, pending clinical development and clearance from the U.S. Food and Drug Administration, Bio-Rad said.
June 30, 2021
2020 04 09 21 21 1283 Bio Rad Aacc 2019 400
OmniSeq, Labcorp launch new oncology test
By LabPulse.com staff writers
OmniSeq Insight is a solid tumor test that combines genomic and immune profiling with immune gene expression data, according to the firm. Users receive test results in a report that includes a summary of U.S. Food and Drug Administration-approved therapies that match the tumor profile; they also receive recommendations for treatment based on information from a proprietary database that includes National Comprehensive Cancer Network (NCCN) guidelines.
June 13, 2021
2021 06 14 23 12 5436 Test Tube Lab Biomaterials 400
FDA puts kibosh on use of Innova Medical coronavirus test
By Brian Casey
In a June 10 notice, the FDA said it had "significant concerns" that the performance of Innova's SARS-CoV-2 Antigen Rapid Qualitative Test had not been proven in clinical studies. Also, the FDA noted that the test had not been authorized or cleared by the agency for commercial distribution in the U.S.
June 9, 2021
2019 02 13 19 24 5396 Fda Logo V2 400
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