Navigation Links
Specific Diagnostics Commences US Clinical Trials for FDA 510(k) Clearance of its Reveal Rapid AST System
Date:10/7/2021

Specific Diagnostics announces today the commencement of its US clinical studies for the Reveal Rapid AST System for blood infection. Trials will entail 3 months of data collection followed by submission for FDA consideration of 510(k) clearance of the Reveal test.

In Europe, where the Reveal is launched under CE-IVD registration, 11 studies across France and England comprising over 1,400 clinical positive blood culture samples, yielding overall accuracy of 97.6% have been completed, with 4 of these studies now reported by submitted abstracts, complementing the similar results reported by Henry Ford Health System in Detroit.

Reveal determines the susceptibility of blood infections to antimicrobial drugs in an average of 5 hours, allowing same-shift adjustment of treatment, saving lives while reducing costs and improving the utilization of antibiotics.

Reveal’s CE-marked, low cost, high throughput, broad menu, and small footprint are all suited to wide-spread adoption. Modular system design ensures no single point of failure, 100% uptime, and incremental adoption by hospitals of any size. The unique Reveal Dashboard™ provides the lab easy-to-use realtime tools to monitor trends of infection and resistance as well as instrument performance.

“With preclinical data from over 1,400 clinical samples showing accurate, consistent, rapid, and reliable results,” said Dr. Paul Rhodes, CEO of Specific, “we believe our system is well-prepared for its US clinical trials, and we look forward to introducing this system to key opinion leaders across the US clinical microbiology community.”

About Specific

Specific Diagnostics has developed in vitro diagnostic systems based upon a unique, patented metabolomic signature technology that enables rapid detection and identification of microorganisms as they grow in culture. Its first commercial application applies this fundamental new platform to the rapid determination of antimicrobial susceptibility directly from positive blood cultures, as well as isolate dilutions. Specific is based in Mountain View, CA, with subsidiaries in Ireland, France and the UK.

For press inquiries, please contact: press@specificdx.com

Read the full story at https://www.prweb.com/releases/specific_diagnostics_commences_us_clinical_trials_for_fda_510k_clearance_of_its_reveal_rapid_ast_system/prweb18249719.htm.


'/>"/>
Source: PRWeb
Copyright©2021 Vocus, Inc.
All rights reserved


Related medicine news :

1. Laser Research Introduces ZnSe Medical Laser Optics that are Manufactured to OEM Specifications
2. Society for Immunotherapy of Cancer to Host Unique 2-Day Workshop Focused on Interrogating the Tumor-Specific Surfaceome for Immune Targeting
3. LGC Maine Standards announces VALIDATE® SP1 kit, now specifically targeted for Roche cobas® and Roche COBAS INTEGRA® analyzers
4. Black Book Market Research Ranks iPatientCare Once Again Among Top Specialty-Specific EHR Vendors for 2019
5. Harbour, an Ethereum-based DAO for Managing Token Assets Announces Launch and Releases Technical Specifications
6. NuevaCare, a Leading Home Care Agency Based in San Mateo, Announces Topic-Specific Tags for Home Care, Senior Care, and Home Care Agency Information
7. Author Wesley Gerboth’s newly released “End Time GPS” is a meticulous guide to Jesus's return as described in Scripture, specifically in the book of Revelation.
8. Medforce Technologies Launches Electronic Signature and Data Capture Tool Built Specifically for Healthcare Industry
9. BCAT Celebrates Second Year as Only Autism-Specific NCCA Credential
10. NuevaCare, a Leading San Mateo Home Care Agency, Announces Location-Specific Pages for San Mateo, Hillsborough and Other Communities
11. OriGene Technologies and EdiGene Announce Joint Development of Genome Wide Knockout Cell Lysates, Revolutionizing Western Blot and Antibody Specificity Validation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/30/2021)... , ... March 29, 2021 , ... ... the 21st Century , A Virtual Workshop Presented by WCG FDAnews and Cerulean ... 4:30 pm EDT, https://wcg.swoogo.com/modern-sop-and-quality-systems , Are one’s SOPs written for the ...
(Date:3/30/2021)... ... March 29, 2021 , ... According to data released ... reproductive age (13-44) in need of publicly funded contraception live in counties impacted by ... Colorado’s 64 counties have lost some of their Title X resources. , The ...
(Date:3/30/2021)... ... March 29, 2021 , ... Health Literacy Innovations (HLI), a ... confusion due to low health literacy today announces a new partnership with the ... work with ACAP’s member Safety Net Health Plans, those that provide comprehensive health ...
(Date:3/30/2021)... ... ... Dr. Colin Campbell is proud to announce the 1 year anniversary in their new state ... internal medicine and is a primary care specialist who has been practicing for 23 years. ... keep South Jersey healthy one patient at a time. , “Over the past year, Dr. ...
(Date:3/30/2021)... ... March 30, 2021 , ... The COVID-19 ... and survivors; their families; and their caregivers. Crossroads4Hope is addressing the needs of ... emotional support system, MyGo2Support, which meets needs of people impacted by cancer, no ...
Breaking Medicine News(10 mins):
(Date:3/30/2021)... ... March 29, 2021 , ... The University of Texas Health Science Center ... San Antonio Multispecialty and Research Hospital, a destination center for research and treatment of ... In a nod to the COVID-19 pandemic, the ceremony was held virtually. , William ...
(Date:3/30/2021)... ... March 29, 2021 , ... Iora Health ... primary care, has partnered with Devoted Health , one of the fastest-growing ... across Maricopa County and provides seniors with the highest-quality care and experience possible, ...
(Date:3/30/2021)... CITY (PRWEB) , ... March 29, 2021 , ... ... has joined the Vaccine Credential Initiative (VCI), a group bringing together leading health ... record of vaccination status, based on open, interoperable standards. By joining the VCI ...
Breaking Medicine Technology: