iCAD Receives FDA Approval for FujiFilm Aspire HD Digital Mammography System; Quidel Wins FDA Clearance for Sofia (R) Print E-mail
By Mary Davila   
Thursday, 20 June 2013 17:21
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 20, 2013.

iCAD (NASDAQ: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced approval by the U.S. Food and Drug Administration (FDA) for use of the Company's SecondLook® mammography computer-aided detection (CAD), on the next generation PowerLook Advanced Mammography Platform (AMP)™, for FujiFilm's Aspire™ HD Full-Field Digital Mammography System.

“We are quite pleased to be able to expand our long standing partnership with market leader FujiFilm to offer customers our next generation mammography computer-aided detection platform, PowerLook Advanced Mammography Platform with FujiFilm's family of Aspire HD Full-Field Digital Mammography Systems,” said Ken Ferry, CEO of iCAD. “This FDA approval further validates SecondLook Digital CAD with PowerLook AMP as a leading tool in cancer detection allowing us to deliver the most advanced and comprehensive imaging solutions to the radiology  community.”

PowerLook AMP provides radiologists  with the ability to customize their CAD solution to meet the needs of their individual work environment. The technology expands on iCAD's SecondLook Digital algorithm and is the CAD platform upon which all future breast imaging CAD offerings from iCAD will be built. SecondLook's CAD metrics offer industry-leading tissue and lesion characteristics to support the breast imager's workflow. In addition, PowerLook AMP is the first product of its kind to integrate Mātakina's Volpara® Volumetric Breast Density assessment.

iCAD's PowerLook AMP also provides the most powerful flexible DICOM connectivity solution , enabling universal compatibility with leading PACS and Review Workstations. Additional modules are expected to be released and integrated into PowerLook AMP in the future.



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Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Sofia Strep A fluorescent immunoassay for use on the Sofia Analyzer for the rapid, objective detection of infections by Group A Streptococcus bacteria. These bacteria are the most common cause of bacterial pharyngitis and can also cause rheumatic fever and other potentially serious illnesses.



Also Thursday:



The board of directors of AbbVie Inc. (NYSE: ABBV) declared a quarterly cash dividend of $0.40 per share.
 
Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, has signed an agreement with Fisher HealthCare Inc., part of Thermo Fisher Scientific, for distribution of Atossa's ForeCYTE Breast Health devices, which consist of the patented MASCT pump and ForeCYTE patient collection kits.

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) announce the U.S. Food and Drug Administration (FDA) has approved updates to the full U.S. Prescribing Information (PI) for TRADJENTA®(linagliptin) tablets and JENTADUETO® (linagliptin and metformin hydrochloride) tablets.

Competitive Technologies Inc. (OTCQX:CTTC) held its annual meeting of shareholders earlier today at the Norwalk Inn and Conference Center in Norwalk, Conn. CTTC's Chairman, Peter Brennan conducted the business meeting and President and Chief Executive Officer, Carl O'Connell, provided an overview of the Company's plans.

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced that Executive Vice President and Chief Medical Officer Daniel Levitt, M.D., Ph.D., will give the Grand Rounds presentation today to the prestigious Department of Hematology and Oncology at LSU Medical School in New Orleans.

eHealth, Inc. (NASDAQ: EHTH), the nation's leading private online health insurance exchange for individual and family health insurance, today announced it is partnering with Aon Hewitt, the global talent, retirement and health solutions business of Aon plc (NYSE: AON), to provide enrollment services to employees of Aon Hewitt's clients who choose to enroll in individual health insurance coverage.

FluoroPharma Medical, Inc. (OTCQB: FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, is pleased with currently acquired imaging data from its ongoing Phase II clinical trial for CardioPET™ (FCPHA) to assess myocardial perfusion and fatty acid uptake in coronary artery disease (CAD) patients.

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 the Company has received verbal communication from the U.S. Food and Drug Administration (FDA) requesting additional preclinical safety information for IDX20963, Idenix's lead uridine nucleotide prodrug candidate.
 
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that its Board of Directors has agreed to waive certain “poison pill” provisions to allow BVF Partners L.P., including its affiliates and associates (“BVF”), to increase its ownership of the Company from the previous limit of 19.99% of outstanding common stock to a new limit of 24.99%, subject to certain conditions. BVF has been Ligand’s largest shareholder since the second quarter of 2011 and currently owns 17.7% of the Company's outstanding stock.

Marathon Group Corp. (PINKSHEETS: PDPR) announced today that they have established a new in-house training center at their New York headquarters.

Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced the successful production of a Rotavirus VLP vaccine candidate comprising all four structural antigens of rotavirus (VP2, VP4, VP6 and VP7) using Medicago's plant-based manufacturing platform.

MMRGlobal, Inc. (OTCQB: MMRF), through its wholly owned subsidiary MyMedicalRecords, Inc. (collectively, "MMR"), today announced that it has received a Notice of Allowance ("NOA") from the United States Patent and Trademark Office for U.S. Patent Application Serial No. 13/714,720 entitled, "Method for Providing a User with a Service for Accessing and Collecting Prescriptions."

Neogen Corporation (Nasdaq: NEOG) announced today the development of a new genomic test that offers the dairy cattle industry an unprecedented level of information on the genetic potential of replacement dairy heifers.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX) a biopharmaceutical company focused on the treatment of obesity, today announced the schedule of its upcoming Contrave®(naltrexone sustained release (SR) /bupropion SR) clinical data presentations taking place at the American Diabetes Association (ADA) 73rd Scientific Sessions, June 21-25, 2013.

Pharmacyclics, Inc. (Nasdaq: PCYC) today announced results of a study evaluating ibrutinib, an investigational oral Bruton's tyrosine kinase (BTK) inhibitor in patients with Waldenstrom's Macroglobulinemia (WM).
 
Protalix BioTherapeutics, Inc. (NYSE:PLX) (TASE:PLX), today held an Analyst Event in which included the disclosure of new data regarding three new compounds in development, oral PRX-106 for immune mediated disorders, PRX-110 for Cystic Fibrosis (CF), and PRX-107 for emphysema from heredity alpha1-antitrypsin (AAT) deficiency.

Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Sofia Strep A fluorescent immunoassay for use on the Sofia Analyzer for the rapid, objective detection of infections by Group A Streptococcus bacteria.

Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) announced today the pricing of an underwritten public offering of 8,500,000 primary shares of its common stock at a public offering price of $4.40 per share.

The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ) announced today that trading of PTC Therapeutics (Nasdaq:PTCT), a biopharmaceutical company focused on discovery, development, and commercialization of orally administered small-molecule drugs that regulate the rate and timing of protein production, commenced on The NASDAQ Stock Market on June 20, 2013.

Titan Medical Inc. (TSX VENTURE:TMD) (OTCQX:TITXF) announced today that it recently filed a provisional patent application with the United States Patent and Trademark Office (USPTO) relating to multi-articulating robotic instruments that are being developed as part of the Company's single-incision robotic platform.



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