510(k): Page 4

eMed releases 1M COVID home tests for holiday season demand
By LabPulse.com staff writers
The kits can be purchased through eMed.com, the company said, and provide results in 15 minutes. The kits are authorized under an emergency use authorization from the U.S. Food and Drug Administration, eMed said.
December 19, 2021
2021 08 18 22 53 0531 Covid 19 Self Swab Test 400
Viome Life Sciences highlights clinical results
By LabPulse.com staff writers
The study was published December 8 in NPJ Genomic Medicine and describes a diagnostic method based on a saliva sample for detecting early-stage oral squamous cell carcinoma. The test received breakthrough device designation in May 2021 from the U.S. Food and Drug Administration (FDA). Lab technology for the test was developed at Los Alamos National Laboratory.
December 19, 2021
2021 06 09 22 54 4801 Computer Doctor Scientist 400
Paige AI software gets U.K. medtech innovation evaluation
By LabPulse.com staff writers
MIBs are intended to support the U.K.'s National Health Service (NHS) facilities when they are considering the use of new medical devices, Paige said. This MIB is the first for a digital pathology product, according to the firm.
December 5, 2021
2019 12 13 00 30 9288 Thumbs Up Down New 400
Immunexpress sepsis test gets FDA 510(k) clearance
By LabPulse.com staff writers
SeptiCyte Rapid uses reverse transcription polymerase chain reaction to quantify directly from blood the relative expression of genes involved in a patient's immune response, the company said.
November 29, 2021
2019 02 13 19 24 5396 Fda Logo V2 400
Sense raises $65M in series B financing
By LabPulse.com staff writers
The Veros COVID-19 test is an instrument-free, single-use, rapid, point-of-care molecular diagnostic testing platform that produces results within 15 minutes.
November 16, 2021
2020 10 14 15 59 9456 Business Woman Handshake 400
FDA tightens policy on reviews of lab-developed tests
By Brian Casey
In a November 15 press release, the FDA said it was withdrawing its policy that directed the agency to not enforce premarket review requirements for LDTs. The agency said it was taking the action to "help ensure that COVID-19 tests are accurate and reliable."
November 14, 2021
2020 03 18 20 13 7386 Virus Coronavirus Covid 19 400
Anavasi secures $14.9M from NIH for SARS-CoV-2 assay
By LabPulse.com staff writers
AscencioDx is in clinical trials, and Anavasi expects to file an emergency use authorization (EUA) with the U.S. Food and Drug Administration soon, it said. The EUA will establish the effectiveness of the test in point-of-care settings such as physician offices, emergency rooms, urgent care clinics, mobile testing sites, and colleges and universities, according to Anavasi.
November 9, 2021
2020 04 16 18 56 8041 Virus Coronavirus Sars Co V 2 400
Reforms needed to clear roadblocks to clinical lab testing
By Leah Sherwood
Testing needs during the pandemic are wide ranging and in constant flux, especially with the emergence of multiple strains of SARS-CoV-2. In response, laboratory professionals across the U.S. have been "tirelessly working to provide critical testing during the pandemic but have faced regulatory missteps, staffing strains, and supply-chain shortages," wrote the authors, led by Dr. Eric Konnick.
November 2, 2021
2021 04 27 22 24 2298 Nasal Swab Test 400
BD secures BARDA funds for development of COVID-19 test
By LabPulse.com staff writers
Under terms of the deal, BARDA will extend its support to BD by up to $40.3 million for the development and U.S. Food and Drug Administration (FDA) clearance of five new tests:
November 1, 2021
2019 08 20 21 56 4986 Becton Aacc 2019 400
Natera unveils lung transplant assessment test
By LabPulse.com staff writers
Results from a prospective trial presented at the Chest 2021 virtual conference showed that the donor-derived cell-free DNA transplant test distinguished antibody-mediated and acute cellular rejection from stable patents with a negative predictive value of 97.3%, sensitivity of 89.1%, and an area under the curve (AUC) of 0.91, according to the vendor. In addition, the test was able to distinguish organ injury -- including acute rejection, chronic rejection, and infection -- from stable patients with an AUC of 0.76.
October 18, 2021
2019 04 26 21 45 6845 Lung Lab 400
Prenosis, Roche expand partnership to combat sepsis
By LabPulse.com staff writers
The companies will build on a collaboration they began in 2020. Prenosis will significantly expand its core NOSIS dataset, a large and growing hybrid biomarker-clinical dataset for sepsis care. In addition, the two companies will work together to obtain U.S. Food and Drug Administration clearance for the Prenosis Sepsis Immunoscore and the Roche Elecsys IL-6 assay.
October 13, 2021
2019 07 15 17 19 4107 Bacteria Blood Sepsis 400
NanoDx, SkyWater develop nanoscale tech for COVID testing
By LabPulse.com staff writers
The nanosensor features wires that find and quantify biomarkers and infections in the blood; the technology is based on research that came out of Harvard University, according to NanoDx.
October 5, 2021
2021 10 06 20 31 5504 Nanotechnology 400
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