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Sapheon Submits First Module of PMA Application for VenaSeal Sapheon Closure System

September 20, 2013 12:01 am | by The Associated Press | News | Comments

Sapheon Inc. announced today that it submitted the first module of the pre-market approval (PMA) application for the VenaSeal® Sapheon Closure System to the U.S. Food and Drug Administration (FDA). The submission places Sapheon on track for timely FDA review and expected product launch in the first half of 2015.

FDA Ophthalmic Devices Panel Favorably Votes for the Resure Sealant

September 19, 2013 7:09 pm | by Business Wire | News | Comments

The Food and Drug Administration’s (FDA) Ophthalmic Devices Panel concluded that ReSure Sealant (Ocular Therapeutix, Inc., Bedford, MA), a first-of-a-kind medical device in the United States, is safe and effective for the management of clear corneal wound leaks following cataract surgery.

Researchers Develop a Method that Automatically Delimits Areas of the Brain in Medical Images

September 19, 2013 11:30 am | by Universidad Publica de Navarra | News | Comments

The researchers have developed a method that improves the delimitation of tumors in medical images. As they explained, “when the doctor decides where tumor tissue should be separated from healthy tissue, our algorithm ensures that he/she is never going choose the worst option because the best solution is automatically offered.”

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Photo of the Day: Going 'Bug-Eyed' for Surgery

September 19, 2013 11:16 am | by The Ohio State University | News | Comments

A lens invented at The Ohio State University combines the focusing ability of a human eye with the wide-angle view of an insect eye to capture images with depth. The results could offer surgical imaging that enables doctors to see inside the human body like never before.

Lens Combines Human and Insect Vision to Focus Wide-Angle Views

September 19, 2013 11:09 am | by The Ohio State University | News | Comments

A lens invented at The Ohio State University combines the focusing ability of a human eye with the wide-angle view of an insect eye to capture images with depth. The results could be smartphones that rival the photo quality of digital cameras, and surgical imaging that enables doctors to see inside the human body like never before.

Keystone Heart’s TriGuard Cerebral Protection Device Receives CE Marking

September 19, 2013 10:50 am | by PR Newswire | News | Comments

The CE marked TriGuard is the only device designed to cover all three aortic cerebral branches to minimize the risk of cerebral damage during Transcatheter Aortic Valve Replacement (TAVR) and other cardiovascular procedures. It is the only system designed for placement via one of two femoral artery access ports.

Implant Removal After Fracture Healing

September 18, 2013 10:52 am | by University Medical Center Utrecht | News | Comments

Patients who continue to suffer inconvenience after a healed bone fracture may be better off having any plates, pins and screws removed. Scientific research headed by Dagmar Vos, who took her doctoral degree at University Medical Center (UMC) Utrecht on 17 September, demonstrates that most complaints and symptoms, such as pain and restricted motion, improve after removing these so-called osteosynthesis materials.

UCLA Doctors Successfully 'Vacuum' Two-Foot Blood Clot Out of Patient's Heart

September 18, 2013 10:02 am | by University of California - Los Angeles Health Sciences | News | Comments

Todd Dunlap, 62, arrived at Ronald Reagan UCLA Medical Center's emergency room on Aug. 8 suffering from shortness of breath, fatigue and extreme cold. When a CT scan revealed a 24-inch clot stretching from his legs into his heart, doctors feared the mass could break loose and lodge in his lungs, blocking oxygen and killing him instantly.

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Information Conveyed to Urologists Regarding Laser Fiber Diameter Is Incorrect

September 18, 2013 9:41 am | by European Association of Urology | News | Comments

Neither the total nor the core diameters of laser fibers correspond to the advertised laser fiber diameter, revealed a new study investigating lasers used for urological surgery. Furthermore, there are serious differences between manufacturers of fibers with a supposedly equal diameter.

Speeding Up Cancer Diagnosis During Surgery

September 17, 2013 1:21 pm | by The University of Nottingham | News | Comments

With funding from the National Institute for Health Research, experts at The University of Nottingham have developed a highly accurate prototype technique which can produce a detailed ‘spectroscopic fingerprint’ of each tissue layer removed during surgery.

Smith & Nephew Releases New DURAFIBER Ag Dressing to Address Bacterial Contamination

September 17, 2013 1:05 pm | by PR Newswire | News | Comments

Smith & Nephew, the global medical technology business, announces the US introduction of DURAFIBER Ag antimicrobial gelling fiber dressing. This new offering in the DURAFIBER portfolio combines the highly absorbent, gelling fiber filler dressing with the benefits of silver (Ag).

New Molecular Imaging Agents Being Developed for Fluorescence-Guided Brain Cancer Surgery

September 17, 2013 12:00 pm | by The Associated Press | News | Comments

Surgery is the cornerstone of oncology treatment, and molecularly-targeted fluorescent imaging agents have the potential to guide surgical resection by highlighting the biological margins of the disease. However, development and testing of such molecular imaging agents has been lacking.

Osteoarthritis and the (not so) Painful Step Toward a Cure

September 17, 2013 10:48 am | by The Journal of Visualized Experiments | News | Comments

On Tuesday, September 17, JoVE, the Journal of Visualized Experiments, will publish a novel technique for imaging muscle function while in motion. Research in this area could uncover the root of musculoskeletal disorders, such as the development of osteoarthritis following ACL surgery.

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Japan clears SpineGuard's PediGuard surgical device

September 16, 2013 12:40 pm | by Mass Device | News | Comments

SpineGuard said it landed Japanese Ninsho approval for its PediGuard, a handheld surgical product that helps guide proper spine screw placement. Paris- and San Francisco-based SpineGuard is touting it as regulatory win in the world's 2nd-largest spine market, after the U.S., according to a release.

Study: Minimally Invasive Prostate Surgery Safer than Open Surgery

September 16, 2013 11:19 am | by Globe Newswire | News | Comments

The study found that minimally invasive surgery for prostate cancer, including laparoscopic and robotic-assisted surgery, was associated with lower transfusion rates, shorter length of hospital stay, and lower serious postoperative complication and mortality rates compared to open prostatectomy.

Instrumentation for Less Invasive Surgical Fixation of Rib Fractures

September 13, 2013 11:34 am | by DePuy Synthes | News | Comments

DePuy Synthes CMF, a leader in skeletal and soft tissue repair and reconstruction, announced the launch of new instrumentation that enables less invasive surgical fixation and stabilization of rib fractures with the company's MatrixRIB™ System of precontoured, low-profile titanium plates, locking screws and intramedullary splints.

RTI Surgical spikes after dodging FDA warning

September 13, 2013 11:29 am | by Mass Device | News | Comments

Florida-based RTI Surgical announced this week that a new inspection of its manufacturing facility confirmed that the company had taken the appropriate actions to correct issues cited in an FDA warning letter issued last year. The announcement sent RTIX shares up 12%...

Smith & Nephew wants San Diego Chargers team doctor's suit dismissed

September 13, 2013 11:11 am | by Mass Device | News | Comments

Smith & Nephew wants a federal judge in California to toss a lawsuit filed by a doctor who blames a botched hip implantation on the British medical device company. Dr. David Chao sued Smith & Nephew in the U.S. District Court for Southern California, alleging that inadequate training and faulty surgical scissors for SNN's Birmingham Hip Resurfacing implant led to the botched surgery on Kathleen Adams in 2007.

Smith & Nephew’s DURAFIBER Ag Dressing Addresses Bacterial Contamination

September 13, 2013 10:56 am | by PR Newswire | News | Comments

Smith & Nephew, the global medical technology business, announces the US introduction of DURAFIBER Ag antimicrobial gelling fiber dressing. This new offering in the DURAFIBER portfolio combines the highly absorbent, gelling fiber filler dressing with the benefits of silver (Ag).

Misonix Supports Uganda Spine Surgery Mission with Ultrasonic BoneScalpelT

September 12, 2013 5:09 pm | by The Associated Press | News | Comments

Misonix, Inc. announced today that it supported this year's Uganda Spine Surgery Mission organized by leading spine surgeon Dr. Isador Lieberman, from the Texas Back Institute in Plano, TX, by donating the use of the ultrasonic BoneScalpel during the performed spinal surgeries.

Appeals court reverses St. Jude Medical win over Access Closure

September 12, 2013 2:10 pm | by Mass Device | News | Comments

A federal appeals court overturned a portion of a legal win for St. Jude Medical yesterday, ruling that a lower court erred in invoking the "safe harbor" provision against double-patenting claims in a patent infringement lawsuit against Access Closure Inc.

Titan Medical Completes Functional Prototype of SPORT Surgical System

September 12, 2013 10:52 am | by Titan Medical | News | Comments

Titan Medical Inc. has announced that it has successfully completed development of a functional prototype of its Single Port Orifice Robotic Technology (SPORT™) Surgical System. The SPORT™ Surgical System prototype successfully demonstrates the key features of the system, including...

The Pulse: Robots Remove Brain Tumors

September 12, 2013 10:12 am | by Eric Sorensen, Coordinator of Multimedia Development | Videos | Comments

On this episode of The Pulse, brought to you by MDT TV, we’re removing brain tumors with robots, using MetaboShield to help obesity, regenerating heart tissue, and pairing glucometers with smartphones for ease of use.      

FDA Approval for Endovascular Repair of Aortic Dissection

September 12, 2013 10:12 am | by W. L. Gore & Associates | News | Comments

W. L. Gore & Associates (Gore) has announced that the US Food and Drug Administration (FDA) has approved the Conformable GORE® TAG® Thoracic Endoprosthesis for endovascular repair of acute and chronic Type B dissections of the descending thoracic aorta. This durable endoprosthesis is the only device to...

El Camino Hospital Enrolls Second Patient in Global Clinical Trial Evaluating the Medtronic CoreValve® System in Intermediate Risk Patients with Aortic Valve Disease

September 11, 2013 3:38 pm | by Business Wire | News | Comments

El Camino Hospital, in partnership with the Taft Center for Clinical Research and the Fogarty Clinical Research Institute, both a part of the Fogarty Institute for Innovation, announced today that it has enrolled its second patient in a global clinical trial comparing the Medtronic CoreValve® System with surgical aortic valve replacement in patients with severe aortic stenosis who are at intermediate risk for open-heart surgery.

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