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OraSure commences enrollment in final study for FDA approval of OraQuick Rapid HIV-1/2 OTC test

OraSure Technologies, Inc., the market leader in oral fluid diagnostics, announced today that it has enrolled the first subject in its final phase of clinical studies for United States Food and Drug Administration ("FDA") approval of the Company's OraQuick® Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter ("OTC") market.

13 Dec 2010

Combination of SPECT and CT scans could offer protection against lymphedema in breast cancer patients

With guidance from a specialized scan, radiation oncologists at Mayo Clinic were able to reduce by 55 percent the number of lymph nodes critical for removing fluid from the arm that received damaging radiation doses.

13 Dec 2010

New DNA-based testing technology for tuberculosis treatment

The driving force behind the rapid tuberculosis test that received World Health Organization endorsement this week is Dr. David Alland, chief of the Division of Infectious Disease at UMDNJ-New Jersey Medical School.

13 Dec 2010

Simple fingertip test may help evaluate risk for CTS in breast cancer patients

A gene target for drug resistance, a triple-drug cocktail for triple negative breast cancer, and patients' risk for carpal tunnel syndrome are among study highlights scheduled to be presented by Johns Hopkins Kimmel Cancer Center scientists during the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held Dec. 8-12. The information is embargoed for the time of presentation at the symposium.

13 Dec 2010

Study shows stereotactic radiation therapy as effective as surgery in elderly patients with early-stage lung cancer

A new study shows that a new type of targeted radiation therapy called stereotactic radiation therapy is just as good as surgery for patients aged 75 and older with early-stage lung cancer, according to research presented at the 2010 Chicago Multidisciplinary Symposium in Thoracic Oncology. This symposium is sponsored by the American Society for Radiation Oncology (ASTRO), the American Society of Clinical Oncology (ASCO), the International Association for the Study of Lung Cancer (ISLAC) and the University of Chicago.

13 Dec 2010

New York City surgeon performs first revision rhinoplasty cases with FDA approved PDS Plate

Today Dr. Steven Pearlman, prominent facial plastic and reconstructive surgeon based in New York City, will be performing one of the first revision rhinoplasty cases with the newly FDA approved PDS Plate. This revolutionary procedure will mark a giant leap in the world of cosmetic and reconstructive surgery.

13 Dec 2010

Mayo clinic creates new computerized radiation tracking system

Mayo Clinic is initiating a new imaging exam tracking system that, among other things, enables a comprehensive view of a patient's radiation exposures over time.

13 Dec 2010

Sound masking therapy is of uncertain benefit when used alone to treat tinnitus

Tinnitus — what many think of as "ringing in the ears" — is the perception of sound without any real acoustic stimulation. Sound masking therapy, a common component of tinnitus treatment, is of uncertain benefit when used on its own, a new evidence review finds.

10 Dec 2010

MMI-USA announces limited launch of new Smart Toe II Hammertoe Fixation System

MMI-USA, a subsidiary of Memometal Technologies S.A., a global orthopaedic manufacturer headquartered in France, announces the limited launch of the new Smart Toe® II Hammertoe Fixation System. The product becomes an important piece of a comprehensive system for forefoot fixation, and reinforces the most widely used franchise of intramedullary implants of this kind in the world.

10 Dec 2010

Complete Genomics announces CNV and SV results as part of complete human genome sequencing service

Complete Genomics Inc. announced today that its customers will now receive copy number variation (CNV) and structural variation (SV) results as part of the CGA™ Service. This new enhancement includes additional types of variation data including quantitative, large-scale copy number measurements and larger inter- and intrachromosomal rearrangements.

10 Dec 2010

Tru-D UV-C device effective in reducing pathogens on all environmental surfaces in hospital patient rooms

Results of an eight-month hospital study, "Room Decontamination with UV Radiation," were published in the October 2010 issue of "Infection Control and Hospital Epidemiology." The study evaluated the ability of an automated UV device, Tru-D, to decontaminate patient rooms contaminated with MRSA, VRE, C. difficile and a MDR strain of Acinetobacter baumannii.

10 Dec 2010

Tomophase receives FDA 510(k) clearance to market Optical Coherence Tomography Imaging System

Tomophase Corporation, developer of the non-invasive Optical Coherence Tomography Imaging System (OCTIS™) and other devices, announced today that it has received FDA 510(k) clearance to market OCTIS.

10 Dec 2010

Pisgah's technology imparts abuse deterrence to commonly abused prescription drugs

Pisgah Labs announced today the findings from a proof of concept study confirming Pisgah's technology imparts abuse deterrence to commonly abused prescription drugs, particularly narcotics. The controlled study, conducted in dogs, was performed with the un-formulated active ingredient, hydrocodone, as modified according to a host of patent applications filed by Pisgah Labs with the United States Patent and Trademark Office (http://www.uspto.gov).

10 Dec 2010

Toshiba to market Elekta's products and clinical solutions in Japanese radiotherapy market

Elekta K.K., a wholly owned subsidiary of Elekta AB, has entered into a sales and marketing agreement with Toshiba Medical Systems Corporation in Japan.

From Elekta 10 Dec 2010

STENTYS initiates international APPOSITION III self-apposing stent study in AMI patients

STENTYS S.A., which develops innovative stents to treat Acute Myocardial Infarction (AMI), announced today that it has begun the international APPOSITION III study of its self-apposing stent, with 50 patients already enrolled out of a total of 500. The trial primary endpoint is Major Adverse Cardiac Events at 12 months post-procedure.

10 Dec 2010

AvMed to optimize Member Services call center operation with Panviva SupportPoint

AvMed Health Plans announced today that it has chosen Panviva SupportPoint, a world-wide leader in Business Process Guidance (BPG) systems, to optimize its Member Services call center operation and drive even higher levels of member satisfaction.

10 Dec 2010

Harvard Bioscience files two major patents in regenerative medicine

Harvard Bioscience, Inc., a global developer, manufacturer and marketer of a broad range of specialized products used to advance life science research and regenerative medicine, has filed two major patents in the field of regenerative medicine, the first covering 61 claims for its stem cell therapy injectors and the second for 338 claims for bioreactors for organ growth.

From Harvard Bioscience 10 Dec 2010

FDA grants Neoprobe Type B pre-IND meeting for RIGS technology BLA

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has requested and been granted a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding its RIGS® technology Biologic License Application (BLA). The pre-IND meeting request is another step in Neoprobe's efforts to develop and commercialize the RIGS technology designed to enhance the surgical treatment of patients with solid tumor cancers.

10 Dec 2010

First genetic test on developing risk of Alzheimer's disease and heart attacks

Alzheimer and heart attacks have been found to share common genetic basis. The research leads the way to the first genetic test on developing the risk of the diseases even at a young age. According to Federico Licastro, an immunologist at the University of Bologna who coordinated the study published in the scientific journal, Journal of Alzheimer's Disease, a test is now ready. "They are already selling it in America", he says, citing the case of a private firm in New Mexico (USA) that collaborated on the study. "But the tests could easily be also conducted wherever, using a simple blood test".

10 Dec 2010

Simple molecular sensor color test to determine safe fluoride levels

Used in the proper amounts, it can make teeth stronger and aid in the treatment of osteoporosis. When excessive amounts are consumed, however, it can be a killer - a carcinogen that causes bone, lung and bladder cancers. The "it" is fluoride, a common additive in most American communities' drinking water and an ingredient in the vast majority of commercially produced adult toothpastes.

10 Dec 2010

Device / Technology News

OraSure commences enrollment in final study for FDA approval of OraQuick Rapid HIV-1/2 OTC test

Combination of SPECT and CT scans could offer protection against lymphedema in breast cancer patients

New DNA-based testing technology for tuberculosis treatment

Simple fingertip test may help evaluate risk for CTS in breast cancer patients

Study shows stereotactic radiation therapy as effective as surgery in elderly patients with early-stage lung cancer

New York City surgeon performs first revision rhinoplasty cases with FDA approved PDS Plate

Mayo clinic creates new computerized radiation tracking system

Sound masking therapy is of uncertain benefit when used alone to treat tinnitus

MMI-USA announces limited launch of new Smart Toe II Hammertoe Fixation System

Complete Genomics announces CNV and SV results as part of complete human genome sequencing service

Tru-D UV-C device effective in reducing pathogens on all environmental surfaces in hospital patient rooms

Tomophase receives FDA 510(k) clearance to market Optical Coherence Tomography Imaging System

Pisgah's technology imparts abuse deterrence to commonly abused prescription drugs

Toshiba to market Elekta's products and clinical solutions in Japanese radiotherapy market

STENTYS initiates international APPOSITION III self-apposing stent study in AMI patients

AvMed to optimize Member Services call center operation with Panviva SupportPoint

Harvard Bioscience files two major patents in regenerative medicine

FDA grants Neoprobe Type B pre-IND meeting for RIGS technology BLA

First genetic test on developing risk of Alzheimer's disease and heart attacks

Simple molecular sensor color test to determine safe fluoride levels

Todd Bauman and Chris Povich

Scaling organ‑chip technology for human‑relevant drug discovery

Unlocking drug amorphization: Continuous, solvent-free twin screw granulation

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