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Exact Sciences Completes Enrollment of DeeP-C Clinical Trial for Colorectal Cancer Screening

November 15, 2012 7:30 am | by The Associated Press | News | Comments

MADISON, Wis.--(BUSINESS WIRE)--Nov 15, 2012--Exact Sciences Corp. (Nasdaq: EXAS) today announced it has completed patient enrollment in its DeeP-C pivotal trial for colorectal cancer screening. The study enrolled more than 12,700 patients at sites in the United States and Canada. Senior Research...

EnteroMedics to Present at the Piper Jaffray 24th Annual Healthcare Conference

November 15, 2012 7:00 am | by The Associated Press | News | Comments

EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer, is scheduled to...

CardioDx Announces Data Demonstrating the Clinical Utility of Its Gene Expression Test for Obstructive Coronary Artery Disease in Patients 65 or Older

November 15, 2012 7:00 am | by The Associated Press | News | Comments

PALO ALTO, Calif.--(BUSINESS WIRE)--Nov 15, 2012--CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced results from a study evaluating the impact of the Corus ® CAD gene expression test on clinician decision-making in the assessment of patients with...

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Potential New Technique for Anticancer Radiotherapy Could Provide Alternative to Brachytherapy

November 15, 2012 12:05 am | by AACR | News | Comments

New approach could be alternative to surgical implantation of radioactive “seeds.” Injected radioactive substance was retained in tumors in mice. Tumor growth was delayed in all treated animals. PHILADELPHIA — A promising new approach to treating solid tumors with radiation was highly efficacious and minimally toxic to healthy tissue in a mouse model of cancer, [...]

Allied Minds pumps $1M into cardiac tool developer

November 15, 2012 12:00 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Allied Minds, an investment firm in Boston that says it bridges the gap between basic research and commercialization, has launched a new medical technology company.

Quanterix raises $18.5M, inks deal with bioMerieux

November 15, 2012 12:00 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Quanterix, a privately-held maker of diagnostic tests, has raised $18.5 million Series C funding round, which includes a $15 million equity stake from new investor bioMerieux. Existing investors ARCH Venture Partners, Bain Capital Ventures and Flagship Ventures and In-Q-Tel, a non-profit strategic investor located in Arlington, Va., also took part.

Solos Endoscopy ends Q3 with $3.4M in the bank

November 15, 2012 12:00 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Solos Endoscopy Inc. (OTCPK: SNDY), a Boston-based maker of various medical instruments, ended its third quarter with $3.4 million in assets, up $1 million from three months ago, due to cost-cutting measures taken since the beginning of the year.

Teleflex Receives FDA 510(k) Clearance for Nylus™ PICC with Semprus Sustain™ Technology

November 14, 2012 5:00 pm | by The Associated Press | News | Comments

LIMERICK, Pa.--(BUSINESS WIRE)--Nov 14, 2012--Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, has announced that its Semprus BioSciences subsidiary has been granted 510(k) clearance for the Company’s innovative vascular access catheter,...

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LED Medical Diagnostics Reports 2012 Third Quarter Results

November 14, 2012 4:45 pm | by The Associated Press | News | Comments

LED Medical Diagnostics Inc. (TSX VENTURE:LMD) ("LED" or the "Company"), manufacturer of the VELscope Vx® the market-leading early-stage oral cancer detection device, today announced its financial results for the third quarter ended September 30, 2012, reported in Canadian dollars and in...

Biotronik touts IDE approval, 1st implant for Pulsar-18 stent in Bioflex-I trial

November 14, 2012 3:45 pm | by Mass Device | News | Comments

Biotronik won FDA investigational device exemption and announced the 1st U.S. implant of its latest-generation Pulsar-18 self-expanding stent. Cardiovascular medical device maker Biotronik touted FDA investigational device exemption for and 1st U.S. implantation of its Pulsar-18 self-expanding stent, the latest in the company's line of peripheral artery stents. The FDA approval granted the Lake Oswego, Ore.-based company approval to add U.S. patients to its prospective, non-randomized study of the Pulsar-18 stent in the BioFlex-1 trial, which also includes centers in Europe and Canada, according to a press release. News Well, Clinical Trials, Food & Drug Administration (FDA), Investigational Device Exemption (IDE), Peripheral Stents, Regulatory/Compliance, Stentsread more

FDA clears Cerner's iPhone-friendly mobile fetal monitoring system

November 14, 2012 3:08 pm | by Mass Device | News | Comments

Cerner lands FDA clearance for its Cerner FetaLink+, a mobile maternal and fetal monitoring device that could help clinicians provide high level of care for patients. Kansas City, Mo.-based healthcare provider Cerner (NSDQ:CERN) received FDA clearance to market its mobile maternal and fetal monitoring system, called Cerner FetaLink+, a device that help clinicians monitor mothers and babies using iPads or iPhones. News Well, 510(k), Food & Drug Administration (FDA), Health Information Technology, Pediatrics, Regulatory/Compliance, Remote Patient Monitoringread more

FDA blocks Hospira Symbiq touchscreen-enabled infusion pump imports

November 14, 2012 2:46 pm | by Mass Device | News | Comments

The FDA prohibits Hospira from importing any new Symbiq infusion pumps systems after the medical device company recalled the devices over a touchscreen issue. Infusion pump maker Hospira (NYSE:HSP) found itself in deepening water after the FDA decided to prohibit the company from importing any new lots of its Symbiq touchscreen-enabled infusion pumps. News Well, Drug Pumps, Food & Drug Administration (FDA), Recallsread more

Dynamic Healthcare Services Acquires HomeTown Oxygen, Pittsburgh, LLC, a Provider of Medical Equipment and Respiratory Therapy Products and Services based in Monroeville, PA

November 14, 2012 2:26 pm | by Bio-Medicine.Org | News | Comments

HARRISBURG, Pa., Nov. 14, 2012 /- Dynamic Healthcare Services, Inc. ("DHS") a portfolio company of GMH Ventures LLC ("GMH") announced today that it acquired HomeTown Oxygen, Pittsburgh, LLC ("HomeTown") of Monroeville, PA on November 8, 2012. The terms of the acquisition were not disclosed. HomeTown is a full service distributor of medical products and equipment including res...

National VC group targets medical device tax repeal, relaxation

November 14, 2012 2:19 pm | by Mass Device | News | Comments

The National Venture Capital Assn. names the 2.3% medical device tax contained in the Affordable Care Act among its top repeal priorities, entertaining opportunities for the industry to repeal or relax the levy. The National Venture Capital Assn. has the impending medical device tax in its cross-hairs as a top priority for take-down, according to the organization. News Well, Capitol Hill, Medical Device Tax, Venture Capital/Private Equityread more

Nelson Laboratories Compliant With New FDA Medical Device Registration Requirement

November 14, 2012 12:11 pm | by The Associated Press | News | Comments

Nelson Laboratories (www.nelsonlabs.com) today announced compliance with the FDA Safety and Innovation Act (FDASIA) regarding updated requirements for the registration and listing of medical devices for contract sterilizers of non-exempt devices who do not commercially distribute product. ...

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