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Clinical Data Submitted Seeking Expanded Claims for Diagnostic Systems.
2001 JAN 18 - (NewsRx.com) -- TriPath Imaging, Inc. (TPTH) (TriPath), Burlington, North Carolina, announced that the company has submitted new clinical data to the U.S. Food and Drug Administration (FDA) to support applications to expand the claims for the AutoPap Primary Screening System (AutoPap System or AutoPap) and AutoCyte Prep System (AutoCyte Prep) to include the screening of AutoCyte Prep thin-layer preparations on the AutoPap Primary Screening System and to automate the initial steps in the AutoCyte Prep laboratory slide preparation process.
In a supplemental filing to its PreMarket Approval (PMA) of the AutoPap System TriPath submitted data from a prospective, masked clinical trial in which thin-layer slides, prepared using the AutoCyte Prep System, were processed on the AutoPap System and screened by laboratory personnel. Approval of the AutoCyte Prep and AutoPap combination will enable TriPath to offer laboratories the first automated screening solution for both conventional and ...
- NeoPath and AutoCyte Agree to Jointly Pursue a Study to Obtain FDA Supplemental...
- Press release article from: PR Newswire March 23, 1999 700+ words
...also screen the newer AutoCyte PREP slides. This agreement...healthcare." The AutoPap System, developed by NeoPath...In May 1998, the AutoPap System was approved by the...manufactures and markets AutoCyte PREP, a proprietary automated...
- NeoPath and AutoCyte Agree to Jointly Pursue a Study to Obtain FDA Supplemental...
- Press release article from: Business Wire March 23, 1999 700+ words
...also screen the newer AutoCyte PREP slides. This agreement...healthcare." The AutoPap System, developed by NeoPath...In May 1998, the AutoPap System was approved by the...manufactures and markets AutoCyte PREP, a proprietary automated...
- Research Supporting NeoPath's AutoPap System Presented At Cytopathology...
- Press release article from: Business Wire November 12, 1998 700+ words
...analysis showed that the AutoPap System found cancers that...integration of the AutoPap System and AutoCyte's liquid...effectiveness of the AutoPap System in a quality control...the study using AutoCyte Prep slides demonstrates...
- TriPath Imaging, Inc. Submits Supplement to FDA for AutoPap(R) System Screening...
- Press release article from: PR Newswire October 6, 1999 700+ words
...identifies a percentage of AutoCyte PREP slides as being normal...conventional Pap smears and AutoCyte PREP System(TM) thin...effectiveness of the AutoPap system. This will enable...delivered through the AutoCyte PREP System(TM), a proprietary...
- TriPath Submits Supplements to FDA Seeking Expanded Claims for the AutoPap(R)...
- Press release article from: PR Newswire December 22, 2000 700+ words
...Screening System ("AutoPap(R) System", or "AutoPap(R)") and AutoCyte PREP System(TM) ("AutoCyte PREP(TM)") to include the screening of AutoCyte PREP(TM) thin-layer preparations on the AutoPap(R) Primary Screening...
- Nikon to distribute NeoPath's AutoPap system in Japan.
- Press release article from: Business Wire December 20, 1996 700+ words
...year Distribution Agreement for the AutoPap System, helping NeoPath build a significant...promote, market and distribute the AutoPap System throughout Japan on a lease, license...distribution, and maintenance of the AutoPap System in Japan. Colby Group International...
- NIKON TO DISTRIBUTE THE NEOPATH AUTOPAP SYSTEM IN JAPAN.
- Press release article from: Business Wire July 2, 1996 700+ words
...authorized distributor of NeoPath's AutoPap System in Japan for a minimum of five years...healthcare providers to provide the AutoPap System to enhance quality control in Pap smear...Japan for our product." NeoPath's AutoPap System is a quality control device to rescreen...
- NeoPath's AutoPap System approved for primary screening in Japan.
- Press release article from: Business Wire March 19, 1997 700+ words
...and Welfare in Japan has approved the AutoPap System(R) for sale as a primary screener...with Nikon Corp. to distribute the AutoPap System will enable us to more quickly penetrate...Systems." As a Primary Screener, the AutoPap System will analyze and classify Pap smears...
Source: HighBeam Research, Clinical Data Submitted Seeking Expanded Claims for Diagnostic...