Endoscopy News and Research

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FDA grants SEDASYS System appeal

Ethicon Endo-Surgery, Inc. (EES) today announced that the Commissioner's Office of the U.S. Food and Drug Administration (FDA) has granted the appeal of the Center for Devices and Radiological Health's (CDRH) denial of the SEDASYS System Premarket Approval Application (PMA). As a result, a new Independent Advisory Panel will be appointed to reconsider the SEDASYS System clinical trial data and application.

11 Nov 2010

MicroAire and Arthrex enter agreement to settle ECTR patent infringement suit

MicroAire Surgical Instruments LLC and Arthrex Inc. announced today that they have entered an agreement to settle a suit accusing Arthrex of patent infringement and breach of contract. At issue was the patented technology that MicroAire owns for minimally invasive treatment of Carpal Tunnel Syndrome.

10 Nov 2010

Valley Anesthesiology Consultants' mobile services division receives AAAHC accreditation

VAC Mobile Services, a division of Valley Anesthesiology Consultants, has achieved accreditation by the Accreditation Association for Ambulatory Health Care (AAAHC). Valley is one of only 10 office-based anesthesia groups nationwide to receive AAAHC accreditation, and the only office-based anesthesia organization in Arizona currently accredited by AAAHC.

9 Nov 2010

Cook Medical's controlled-release esophageal stent receives FDA clearance

Cook Medical's controlled-release esophageal stent fully covered in silicone has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), making available yet another advanced solution from Cook Medical, the only full-line supplier of endoscopic devices.

9 Nov 2010

Santarus's budesonide MMX drug shows positive result for active ulcerative colitis

Santarus, Inc. a specialty biopharmaceutical company, today announced positive top-line results from a second Phase III clinical study evaluating the safety and efficacy of budesonide MMX for the induction of remission of mild or moderate active ulcerative colitis.

8 Nov 2010

New laparoscopic instrument mimics human index finger

Microline Surgical, a leading manufacturer of reposable instruments for minimally invasive surgery, today announced the launch of its LapFinger™ finger activated laparoscopic instrument. LapFinger mimics the ultimate dissection tool - the human index finger - enabling surgeons to dissect with confidence, retract with strength and palpate with feel.

4 Nov 2010

Top 10 Medical Innovations for 2011

From pill-sized cameras to radioactive compounds that let doctors "see" inside a patient's brain, Cleveland Clinic's Top 10 Medical Innovations for 2011 showcases new techniques, therapies and approaches to treating a host of diseases.

3 Nov 2010

Health reform law: Tax credits may boost coverage; rationing still hot word

The number of small businesses offering health insurance to workers is projected to increase sharply this year, recent data show, a shift that researchers attribute to a tax credit in the health law.

3 Nov 2010

Repligen 2011 second quarter total revenue increases 35% to $7,307,000

Repligen Corporation today reported results for the second quarter of fiscal year 2011, ended September 30, 2010.

2 Nov 2010

Global Health Partner third quarter revenue increases 17% to SEK 108.8 million

Global Health Partner AB: Revenues increased by 17 percent to SEK 108.8 million (93.3). The operating result amounted to SEK -4.1 million (-13.1)

2 Nov 2010

Intentional foreign body ingestion results in over $2 million hospital costs: Study

A new study from Rhode Island Hospital found that 33 individuals were responsible for 305 cases of medical intervention to remove foreign bodies that were intentionally swallowed, resulting in more than $2 million in estimated hospital costs. The findings appear in the November issue of Clinical Gastroenterology and Hepatology.

1 Nov 2010

Pancreatic cancer develops and spreads more slowly than thought before

Pancreatic cancer develops and spreads much more slowly than scientists have thought, according to new research from Johns Hopkins investigators. The finding indicates that there is a potentially broad window for diagnosis and prevention of the disease.

28 Oct 2010

JMC Professor wins Karl Storz Lifetime Achievement Award in Endourology

Demetrius H. Bagley, M.D., the Nathan Lewis Hatfield Professor of Urology in the Department of Urology at Jefferson Medical College (JMC) of Thomas Jefferson University was recently honored as the 2010 recipient of the Karl Storz Lifetime Achievement Award in Endourology at the World Congress of Endourology. He is also a full Professor of Radiology.

28 Oct 2010

Epigenomics presents data on Septin9 biomarker clinical study for colorectal cancer at UEGW

Epigenomics AG, the cancer diagnostics company, announced that new data obtained in a clinical study with the Company's proprietary Septin9 biomarker for the blood-based detection of colorectal cancer, were presented yesterday at the 18th United European Gastroenterology Week (UEGW) in Barcelona, Spain.

28 Oct 2010

NeedleTech increases production area with new 73,000-square foot manufacturing facility

U.S. Congressman James McGovern, State Representative Elizabeth Poirier and local dignitaries joined Theragenics Corporation executives in ribbon cutting ceremonies on October 15 for a new 73,000-square foot manufacturing facility for the company's subsidiary, NeedleTech Products. The new facility increases NeedleTech's production area by 30% or 20,000 square feet, allowing the company to consolidate two separate older facilities into one location. The new building will allow NeedleTech to expand operations, increase R&D and offer more services to its customers.

25 Oct 2010

WallFlex Biliary RX Stent receives CE Mark approval for benign biliary strictures

Boston Scientific Corporation today announced that its WallFlex Biliary RX Fully Covered Stent has received CE Mark approval for the treatment of benign biliary strictures.

25 Oct 2010

Hepatitis C from anesthetist case assumes new proportions

According to Victoria’s chief health officer yesterday, another 1,100 people would be screened for hepatitis C that could have come from contact with an infected doctor at more than one clinic.

24 Oct 2010

Boston Scientific's Advanix Biliary Plastic Stents receive FDA 510(k) clearance and CE Mark approval

Boston Scientific Corporation today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval to market its Advanix™ Biliary Plastic Stents for the treatment of biliary strictures, including biliary stone disease, benign biliary strictures, and suspected and confirmed malignancies in the biliary system. The product is now available in Europe and other international markets; the Company plans to launch it in the U.S. this quarter.

21 Oct 2010

$OptiNose reports positive results from study of fluticasone delivered by novel device in refractory CRS$

OptiNose reports positive results from study of fluticasone delivered by novel device in refractory CRS

Today OptiNose Inc. announced the positive results of a study evaluating the efficacy of fluticasone when delivered by the Company's novel bi-directional technology in patients with refractory chronic rhinosinusitis (CRS). The results of the study have been published in an article in the September issue of Rhinology.

21 Oct 2010

Nexcore announces acquisition of Meditron product line from CooperSurgical

Nexcore Technologies, Inc. of Waldwick, an original equipment manufacturer of medical devices, today announced it has acquired the Meditron line of gastroenterology endoscopy products from CooperSurgical, Inc. of Trumbull, CT.

21 Oct 2010

Endoscopy News and Research

FDA grants SEDASYS System appeal

MicroAire and Arthrex enter agreement to settle ECTR patent infringement suit

Valley Anesthesiology Consultants' mobile services division receives AAAHC accreditation

Cook Medical's controlled-release esophageal stent receives FDA clearance

Santarus's budesonide MMX drug shows positive result for active ulcerative colitis

New laparoscopic instrument mimics human index finger

Top 10 Medical Innovations for 2011

Health reform law: Tax credits may boost coverage; rationing still hot word

Repligen 2011 second quarter total revenue increases 35% to $7,307,000

Global Health Partner third quarter revenue increases 17% to SEK 108.8 million

Intentional foreign body ingestion results in over $2 million hospital costs: Study

Pancreatic cancer develops and spreads more slowly than thought before

JMC Professor wins Karl Storz Lifetime Achievement Award in Endourology

Epigenomics presents data on Septin9 biomarker clinical study for colorectal cancer at UEGW

NeedleTech increases production area with new 73,000-square foot manufacturing facility

WallFlex Biliary RX Stent receives CE Mark approval for benign biliary strictures

Hepatitis C from anesthetist case assumes new proportions

Boston Scientific's Advanix Biliary Plastic Stents receive FDA 510(k) clearance and CE Mark approval

OptiNose reports positive results from study of fluticasone delivered by novel device in refractory CRS

Nexcore announces acquisition of Meditron product line from CooperSurgical

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