Teleflex Receives FDA Clearance for ARROW GPSCath Balloon Dilatation Catheters in Higher RBP and 80 cm LengthsJuly 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 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 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.
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 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.
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.
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.
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.
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.
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.
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.
As an industry sponsor, Misonix exhibited and demonstrated its innovative BoneScalpel Ultrasonic Bone Cutting System, which is rapidly gaining acceptance with spine surgeons worldwide. Consistent with the scientific theme of the meeting, an abstract titled "Blood Loss Reduced During Surgical Correction of Adolescent Idiopathic Scoliosis (AIS) with an Ultrasonic Bone Scalpel" was presented by Dr. Peter O. Newton in the form of an e-poster.
Nikolai Begg grew up in a box of LEGO bricks and hasn’t stopped tinkering since. He is an accomplished inventor with a portfolio of novel medical devices, and today, Begg was named the recipient of the prestigious $30,000 Lemelson-MIT Student Prize for his inventions that are making surgical procedures less invasive.
In a Special Report in the current issue of Circulation, Boston Medical Center cardiothoracic surgeon Harold Lazar, MD, has found that off-pump coronary artery bypass graft (OPCAB) surgery has failed to show any significant improvement in short-term morbidity or mortality as compared to the traditional on-pump coronary artery bypass graft (CABG) surgery.
Cook Medical launched a new treatment option today for rhinologists who treat patients that suffer from difficult-to-heal conditions in the nasal passages. The Biodesign ENT Repair Graft acts as an adjunct to aid in the natural healing process following nasal and sinus mucosal surgery.
Severe damage to the large vessels from multiple trauma or accidental complications in surgery can cause exsanguinating hemorrhage leading to death. Especially in the thin-walled vena cava abundant with blood, a tear in a small laceration soon widens, requiring a difficult and specialized vascular surgery technique to be fixed.
Ohio-based Minimally Invasive Devices capped an $11.5 million Series B funding round with a final $2.5 million investment from Radius Ventures, according to a company statement. MID said it's putting the new cash into marketing and sales for its FDA-cleared device for laparoscopic surgeons, the FloShield vision system.
Shares of Intuitive Surgical Inc. slumped in after-hours trading Thursday after the robotic surgery device maker said it received a warning letter from the Food and Drug Administration. Intuitive Surgical said the warning relates to two problems the FDA observed during an inspection performed during the second quarter.
Corindus Vascular Robotics announced today that Sanford Aberdeen Medical Center in Aberdeen, S.D. became the first hospital to perform a Robotic Angioplasty for a patient with an acute heart-attack, achieving a far better door-to-balloon time than the national standard.
Integra LifeSciences Holdings Corporation today announced the commercial launch of the Integra(R) Total Foot System 2, which addresses both reconstruction and acute fractures of the forefoot, midfoot and hindfoot. The Total Foot System 2 enhances the current system by offering a wider variety of plates to better meet surgeons' needs.
Hansen Medical and Philips Reinforce Collaboration in Robotic Systems for Endovascular InterventionsJuly 17, 2013 8:00 am | by The Associated Press | News | Comments
Hansen Medical and Royal Philips announced that they have reached an important milestone in their long-term collaboration by securing certified compatibility -- article 12 of the Medical Device Directive 93/42/EEC, as amended by 2007/47/EC -- between Hansen Medical's Magellan Robotic System and Philips' Allura interventional X-ray systems.
Ceterix Orthopaedics has announced commercial availability of the company’s NovoStitch suture passer in the United States. The company’s device enables surgeons to place stitches in tight joint compartments, including those in knees, hips, and shoulders, during minimally invasive arthroscopic surgical procedures.
ulrich medical USA, Inc., today announced the U.S. market release of the uCerv Interbody System which is a spinal implant device used for anterior cervical discectomy and fusion (ACDF) surgical procedures (C2-C7). The uCerv System consists of trapezoidal shaped implants that are available in a parallel or lordotic configuration of various heights.
Misonix announced today that it has received the necessary Registration Certificate from the State Food and Drug Administration (SFDA) of the People's Republic of China (PRC) to market and sell its BoneScalpel (Ultrasonic Osteotome System) product in China.
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