Hologic receives FDA approvable letter. Image Diagnostics jumps on 510k submittal Print E-mail
By Staff and Wire Reports   
Tuesday, 23 November 2010 19:35
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 23, 2010.

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.

CONMED Corporation (NASDAQ:CNMD), a medical technology company specializing in medical devices for surgical and patient monitoring markets, announced today that the Company will participate in the 22nd Annual Piper Jaffray Health Care Conference, on Wednesday, December 1, 2010 at 11:00 AM Eastern time.

Entest BioMedical Inc. (OTCBB: ENTB) Chairman & CEO David Koos covered Entest's short range and mid-range milestones.

GeckoSystems Intl. Corp. (PINKSHEETS: GOSY) announced today that their CEO, Martin Spencer, will also be meeting early next month with a Japanese business partner, Mr. Tommy Matsumoto, of Mr. Hajime Yasumatsu, Chairman, Yasu, Inc. "Mr. Matsumoto is talking with Kansai Electric Power Company's Subsidiary about the CareBot™.

Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the Company will receive a payment of $20 million from the ViiV Healthcare Company for the achievement of a clinical milestone relating to GSK2248761 (known as '761).

IDenta Corp. (PINKSHEETS: IDTA) CE Yaacov Shoham announced today that the company's penetration into the markets in Australia and the surrounding region has been developing rapidly.

Isis Pharmaceuticals, Inc. (Nasdaq:ISIS), the leader in antisense therapeutics, today announced that management will present a company overview at Piper Jaffray's 22nd Annual Health Care Conference on Tuesday, November 30, 2010 at 10:00 a.m. ET at The New York Palace Hotel.

Landauer, Inc. (NYSE: LDR), will release financial results for the fiscal fourth quarter and full year of 2010 pre-market on Tuesday, December 7, 2010.

MELA Sciences, Inc. (NASDAQ: MELA) announced today that Joseph V. Gulfo, MD, President and CEO will present at the Piper Jaffray 22nd Annual Health Care Conference at The New York Palace Hotel in New York City.

Pharmasset, Inc. (Nasdaq:VRUS), a clinical stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections, today reported financial results and operational highlights for the fiscal year ended September 30, 2010.

Omni Bio Pharmaceutical, Inc. (OTC Bulletin Board:OMBP), today announced that U.S. Patent No.7,807,781, entitled "Inhibitors of Serine Protease Activity and Their Use in Methods and Compositions for Treatment of Viral Infections", was issued by the United States Patent and Trademark Office (USPTO) on October 5, 2010.

Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) will webcast its presentation at the 22nd Annual Piper Jaffray Healthcare Conference on Tuesday, November 30, 2010.

Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced that it has settled the outstanding arbitration with Prometheus Laboratories, Inc..

Santeon Group, Inc. (OTCBB: SANT) today announced the filing of its quarterly financial report in which it reported a net profit for the quarter on increased revenues over the prior year.

Transax International Limited (Transax) (PINKSHEETS: TNSX), a network solutions company for healthcare providers and health insurance companies, today reportedfinancial results for the first nine months of 2010 and third quarter ended September 30, 2010.

Volcano Corporation (Nasdaq:VOLC), a leading developer and manufacturer of precision intravascular diagnosis and therapy guidance tools designed to enhance the treatment of coronary and peripheral vascular disease, said today that it will be participating in the 22nd Annual Piper Jaffray Health Care Conference on Tuesday, November 30.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit! Del.icio.us! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus