|Hologic receives FDA approvable letter. Image Diagnostics jumps on 510k submittal|
|By Staff and Wire Reports|
|Tuesday, 23 November 2010 19:35|
Hologic, Inc. (Nasdaq:HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today that the company has received an approvable letter from the U.S. Food and Drug Administration for the Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system. Final approval of the Company's pre-market approval application for the system remains subject to satisfactory review and inspection of its manufacturing facility, methods and controls. The company said it plans to work closely with the FDA to complete this final inspection. Analysts are saying the Selenia Dimensions device, which uses a new technology, tomosynthesis, to produce 3D images, could become a blockbuster product, producing more than $1 billion annually in sales. The product is already in use in Asia, Latin America and Europe.
On heavy volume shares inched up 45 cents or 2.81% to $16.44 and added 14 cents in extended trading.
Imaging Diagnostic Systems, Inc., (IDSI) (OTCBB:IMDS.ob) a pioneer in laser breast imaging, announced today that a Premarket Notification 510(k) was submitted on Monday, November 22, 2010, to the FDA, moving the company forward in the process of seeking marketing clearance for its innovative breast imaging device, the CTLM system.
The CTLM system is an imaging device intended to aid in the diagnosis of breast cancer in a non-invasive procedure. The patient lies face down comfortably on the scanning bed for approximately 10 minutes until the scan is completed. CTLM uses state-of the-art laser technology and proprietary computed algorithms instead of x-rays and breast compression to create three-dimensional views of the blood supply in the breast. These images can be used to complement current breast imaging modalities, providing additional information on the nature of breast abnormalities.
"This submission is a significant step toward the realization of our dream of marketing this unique breast imaging device throughout the United States," stated Linda Grable, CEO of Imaging Diagnostic Systems.
On volume of more than 23 million shares, the stock moved up 56% to $.036.
Affymax, Inc. (NASDAQ:AFFY) today announced it will host an analyst briefing on Thursday, December 2, 2010 at 9:00 a.m. ET.
Affymax management will provide clinical, regulatory and commercial updates on Hematide/peginesatide. There will also be a featured presentation by Dr. Steven Fishbane, lead investigator on the Phase 3 program and chief medical officer of Winthrop-University Hospital and chief of the division of Nephrology and medical director of Winthrop’s Dialysis Network.
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for marketing approval of the single-tablet regimen of Truvada and Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor TMC278 for HIV-1 infection in adults. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.
"Combination antiretroviral therapy has dramatically advanced the field of HIV medicine, but the need remains for new single-tablet regimens that are effective, safe and well tolerated," said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. "Gilead is committed to helping advance HIV treatment by pursuing both scientific research and innovative partnerships that will deliver more options to the healthcare community. We are pleased to work with Tibotec to bring this potentially important new therapy to people living with HIV."
In other news Tuesday:
AVANIR Pharmaceuticals, Inc. (Nasdaq:AVNR) today announced that it will release unaudited financial results for the quarter and fiscal year ended September 30, 2010 before market open on Tuesday, November 30, 2010.
China Medical Technologies, Inc. (Nasdaq:CMED), a leading China-based advanced in-vitro diagnostic company, today announced that it has signed a strategic collaboration agreement with Standard Chartered Bank (China) Limited and that the Company's wholly-owned subsidiary, Beijing Yuande Bio-Medical Engineering Co., Ltd., has signed a strategic collaboration agreement with Guangdong Development Bank.