Research & Development
Policy & Regulation
Trends & Finance
510(k): Page 2
FDA issues updated reagent, instrument guidance
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
Natera files presubmission with FDA for NIPT test
According to the FDA, Q-Subs can serve as helpful tools in the premarket submission process.
August 10, 2022
Abionic nabs IVDR certification for sepsis test
The device detects pancreatic stone protein, an early marker for sepsis, allowing for its identification in about five minutes, Abionic said.
August 8, 2022
Video from AACC: Cytovale immune-response test for sepsis
The San Francisco-based startup has submitted an application to the U.S. Food and Drug Administration (FDA) for clearance of the system and test, which aims to help emergency departments to more effectively and quickly triage patients.
July 28, 2022
FDA clears Angle’s Parsortix breast cancer system
The FDA clearance is the first FDA product clearance to harvest cancer cells from a blood sample for subsequent analysis. This offers the prospect of a new era of personalized cancer care, according to the company.
July 27, 2022
Siemens Healthineers unveils in vitro diagnostics systems at AACC 2022
The system, with the capacity to conduct more than 250,000 clinical chemistry tests per year and more than 25,000 immunoassay tests per year, is in development and under review for potential clearance by the U.S. Food and Drug Administration (FDA), the firm said.
July 26, 2022
Cytovale to present new data on rapid sepsis test at AACC
The firm noted it has already submitted an application to the U.S. Food and Drug Administration for clearance of the system and test, which aims to help emergency departments rapidly and more effectively triage patients.
July 24, 2022
Ellume COVID-19 test available at no cost to the blind
Ellume said it has worked with the U.S. Food and Drug Administration (FDA), the U.S. Department of Health and Human Services, the National Institutes of Health's RADx initiative, and the National Federation of the Blind to ensure that the company's test is accessible to users who are blind or have low vision.
July 14, 2022
Akoya, Acrivon to develop CDx for cancer treatment
OncoSignature identifies cancer patients likely to respond to treatment with ACR-368, a targeted DNA damage response inhibitor therapy that Acrivon is developing.
June 28, 2022
Biocartis, AstraZeneca to develop CDx for EGFR TKI treatment
The firms aim to obtain applicable premarket notification or approval from the U.S. Food and Drug Administration (FDA) for a CDx test on Biocartis' fully automated molecular Idylla platform.
June 21, 2022
Nonagen Bioscience secures CE Mark for bladder cancer test
The urine test detects 10 biomarkers associated with bladder cancer, the company said.
June 16, 2022
Thermo Fisher launching IVDR-compliant RT-PCR system
The updated system is available in all regions that recognize CE-IVD certification and is listed with the U.S. Food and Drug Administration (FDA), Thermo Fisher said.
June 6, 2022
Page 2 of 17