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Class I Medical Device Recall: Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter

August 8, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Optease Retrievable Vena Cava Filter is used for the prevention of recurrent pulmonary embolism in patients under specific situations. The device is implanted into the inferior vena cava and is designed to be retrieved when the patient no longer requires a filter.

Stryker Interventional Spine Launches Two New Products to Expanding Portfolio

August 7, 2013 12:15 pm | by PRNewswire | News | Comments

Stryker Interventional Spine announced the clearance of 510(k)s for two additional products to its portfolio. Venom RF Cannula and Venom Electrode are designed to provide an effective and minimally invasive treatment for facet joint pain. The launch of the 11g iVAS Balloon System addresses the surgical trend of shifting toward less invasive treatment options.

Diamond-Based Lasers for Healthcare

August 7, 2013 10:36 am | by Engineering and Physical Sciences Research Council | News | Comments

Ground-breaking research is harnessing the unique properties of diamonds to develop a new generation of lasers that could lead to many benefits, from better treatment of skin complaints and diabetes-related eye conditions to improved pollution monitoring and aeronautical engineering.

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Commonly Used Catheter's Safety Tied to Patient Population

August 6, 2013 12:11 pm | by Society for Healthcare Epidemiology of America | News | Comments

A new study reports that peripherally inserted central catheters (PICCs) do not reduce the risk of central line associated bloodstream infections (CLABSIs) in hospitalized patients. PICCs have become one of the most commonly used central venous catheters (CVCs) in healthcare settings since they are considered easier and safer to use, with less risk of CLABSIs.

Neurosurgeons Implant One of First MRI-Safe Devices for Pain

August 6, 2013 9:58 am | by Ohio State University Medical Center | News | Comments

Neurosurgeons at The Ohio State University Wexner Medical Center are among the first in the United States to successfully implant an MRI-safe spinal cord stimulator to help patients suffering from chronic back or limb pain. Neurosurgeons Dr. Ali Rezai and Dr. Milind Deogaonkar performed the surgery Aug. 5...

Ocular Therapeutix Announces FDA Panel Meeting for the ReSure® Sealant

August 5, 2013 3:11 pm | by Business Wire | News | Comments

Ocular Therapeutix, Inc. announced today that the U.S. Food and Drug Administration (FDA) has scheduled an Ophthalmic Devices Panel meeting on September 19, 2013 to discuss, make recommendations, and vote on the company’s Premarket Approval (PMA) Application for the ReSure Sealant.

J&J Pleased Chinese Anti-Monopoly Dispute Is Over

August 5, 2013 12:50 pm | by The Associated Press | News | Comments

Healthcare giant Johnson and Johnson says it is pleased to put a legal dispute behind it after a Chinese court ordered it to pay compensation to a former distributor under an anti-monopoly law. Thursday's ruling said Johnson & Johnson was guilty of "vertical monopoly" for setting minimum prices its distributors charged for surgical sutures.

Novel 3D Simulation Technology Helps Surgical Residents Train More Effectively

August 5, 2013 10:58 am | by American College of Surgeons | News | Comments

A novel interactive 3Dimensional (3D) simulation platform offers surgical residents a unique opportunity to hone their diagnostic and patient management skills, and then have those skills accurately evaluated according to a new study appearing in the August issue of the Journal of the American College of Surgeons.

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Researchers Create 'Soft Robotic' Devices Using Water-Based Gels

August 5, 2013 10:55 am | by North Carolina State University | News | Comments

Researchers from North Carolina State University have developed a new technique for creating devices out of a water-based hydrogel material that can be patterned, folded and used to manipulate objects. The technique holds promise for use in "soft robotics" and biomedical applications.

Ocular Therapeutix wins FDA panel date for ReSure sealant

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

An FDA advisory panel is slated to convene Sept. 19 to review the pre-market approval application for Ocular Therapeutix Inc.'s ReSure sealant. The FDA's Ophthalmic Devices Panel will review the PMA for the ReSure product, a hydrogel designed to seal incisions to the cornea made during cataract or intraocular lens placement surgery.

Wrong Site Surgery Cited as Top OR Safety Challenge Among U.S. Hospitals

August 1, 2013 2:00 pm | by Medline | News | Comments

Despite being a rare event, wrong site surgery is the number-one operating room safety concern for 65 percent of OR nurses in the United States, according to a new national survey conducted by Medline Industries, Inc. According to the Joint Commission Center for Transforming Healthcare, wrong site surgery occurs as often as 40 times per week in the U.S

Digirad Announces Sale of Surgical Imaging Technology Assets to Novadaq Technologies

August 1, 2013 6:30 am | by The Associated Press | News | Comments

Digirad Corporation announced today that it has signed an agreement to sell its "Trapper" Surgical Imaging Technology previously under development, as well as license "Trapper" related technology to Novadaq Technologies, a publicly-traded developer of clinically-relevant imaging solutions for use in surgical and outpatient wound care procedures.

ConforMIS raises $168M Series E round

July 31, 2013 3:22 pm | by Mass Device | News | Comments

ConforMIS closed a Series E round worth $167.7 million, raised from a consortium of 88 unnamed investors, according to regulatory filings. The Bedford, Mass.-based medical device company makes personalized knee implants based on scans detailing patients' physiology, creating customized instruments and implants that are shipped in a sterile package surgeons can open on the operating table.

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Mako Surgical says 2Q surgical procedures grow

July 30, 2013 6:21 pm | by The Associated Press | News | Comments

Medical device maker Mako Surgical Corp. posted a larger second-quarter loss on Tuesday, but said surgical procedures performed with its Rio system improved. The company's shares rose $1.02, or 8.2 percent, to $13.45 in after-hours trading.  

Teleflex Receives FDA Clearance for ARROW GPSCath Balloon Dilatation Catheters in Higher RBP and 80 cm Lengths

July 30, 2013 5:00 pm | by Business Wire | News | Comments

Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, has announced that its subsidiary Hotspur Technologies, Inc., which Teleflex acquired in June 2012, received FDA 510(k) clearance to market the company’s ARROW ® GPSCath ® Balloon Dilatation Catheters in Higher Rated Burst Pressure (RBP) and 80 cm lengths.

Poland's First Face Transplant Patient Goes Home

July 30, 2013 9:26 am | by Monika Scislowska, Associated Press | News | Comments

Poland's first face transplant patient was discharged from the hospital Tuesday, speaking with some effort at a press conference just 11 weeks after the extensive surgery that saved his life. The 33-year-old man said he owes his doctors "everything" following a skin-and-bone transplant on May 15.

Hansen Medical agrees to settle shareholders' lawsuit for $8.5M

July 29, 2013 11:46 am | by Mass Device | News | Comments

Hansen Medical said it agreed to pay out $8.5 million in cash and stock to put to rest a shareholders' lawsuit filed over its 2009 restatement of revenues. The Mountain View, Calif.-based robotic surgery company said it agreed to pay $4.25 million in cash and another $4.5 million worth of its own stock to settle the lawsuit.

Intuitive Surgical boosts buyback to about $1.5B

July 29, 2013 10:44 am | by The Associated Press | News | Comments

Robotic surgery device maker Intuitive Surgical Inc. is increasing its current share buyback by $779 million to approximately $1.5 billion and is entering an accelerated repurchase program with Goldman Sachs. President and CEO Dr. Gary Guthart said in a statement on Monday that the increase to its repurchase program and the accelerated buyback shows Intuitive Surgical's confidence in its da Vinci surgical system.

DJO Surgical, a DJO Global Company, Announces the First TaperFill Hip Stem Implanted

July 29, 2013 7:35 am | by Business Wire | News | Comments

DJO Global, Inc., a leading provider of medical device solutions for musculoskeletal health, vascular health and pain management, announced that the first TaperFill™ Total Hip Replacement (THR) was implanted. TaperFill was developed to accommodate a minimally invasive procedure.

A Better Tool for Minimally Invasive Surgery

July 26, 2013 9:34 am | by University of Michigan | Videos | Comments

U-M engineers have developed a new robotic tool which will make performing minimally invasive surgery cheaper and easier, but provides higher functionality over existing low-cost tools. The tool, called Flex Dex, acts as an extension of the surgeon's arm, allowing the doctor to control it with just a turn of the wrist.

'Head-Mount Image Processing Unit' for Endoscopic Image Display

July 25, 2013 1:23 pm | by Sony Corporation | News | Comments

Sony Corporation has announced the launch of a head-mount image processing unit capable of receiving and outputting endoscope image signals, or controlling video images, which can then be displayed in 3D or 2D on an accompanying head-mounted monitor.

IBIS Could Make Keyhole Robotic Surgery Cheaper

July 25, 2013 10:44 am | by Diginfonews | Videos | Comments

The IBIS system, developed at the Tokyo Institute of Technology, uses many off-the shelf devices to perform the same or similar tasks that the more well-known da Vinci surgical robot can perform. Essentially, providing a quality keyhole surgery technology for potentially one tenth the cost, according to the researchers.

Probe into Doctor Using 'Household' Drill

July 24, 2013 11:05 am | by The Associated Press | News | Comments

Officials at a hospital in Moldova are investigating a surgeon's claim that he had to use a handyman's drill to perform an operation because proper equipment was unavailable. Grigore Rusanovschi, a doctor at the Valentin Ignatenco Hospital in Chisinau, says he posted a video online Monday showing him using the drill.

Intuitive Surgical reveals details of FDA warning letter, follow-up visit

July 23, 2013 3:27 pm | by Mass Device | News | Comments

Robot surgical devices maker Intuitive Surgical (NSDQ:ISRG) has had a rough few months, and the tension wasn't much eased by news that the company had been the subject of an FDA warning letter following a facilities inspection. In its most recent financial report, Intuitive said that the FDA had issued a Form FDA 483 warning citing 4 "objectionable observations" from the inspection.

Stryker pulls spinal devices off the shelves following failure reports

July 23, 2013 2:19 pm | by Mass Device | News | Comments

Australia sounded the alarm on Stryker's Oasys Midline Occipital Plate, sending a warning to patients and surgeons that the spine stabilization device might break after surgery. Stryker's spinal stabilization plate is part of the Oasys spinal surgery system.

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