Boston Scientific Corporation has received U.S. FDA clearance and CE Mark approval in Europe for the Expect™ Slimline (SL) Needle, which means it is now globally available for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA) procedures.
Oncology
Barrx Treatment Group Significantly Outperforms Control in Barrett’s Esophagus
Results of a new clinical study into the Barrx RF Ablation platform, acquired by Covidien back in late 2011, say the therapy is effective at treating Barrett’s esophagus. So effective that the trial was stopped and the control group offered the treatment.
Study says Radioembolisation has Potential to Improve Treatment of Liver Cancer Patients
A new study talks of significant reductions in fluoroscopy time, procedure time, radiation dose and contrast dose when using the Surefire Radiation Therapy Infusion System without placing permanent embolic coils.
FDA Clears Next Generation Medigus Muse™ System for GERD Threatment
Israeli medical device company Medigus Ltd. has gained U.S. FDA 510(k) clearance for its next generation MUSE™ system, formerly known as the SRS™ system. Muse is a device which enables an incisionless procedure by performing an anterior partial fundoplication with standard surgical staples in a less invasive way.
FDA Clears ProTom’s Radiance 330® Proton Therapy System
Proton Beam Therapy specialist company ProTom International, Inc. has announced that it has received U.S. FDA 510(k) clearance for its Radiance 330 Proton Therapy System.
FDA Clears Orfit’s Nanor™ Technology for Patient Immobilisation During Radiation Therapy
The FDA has cleared Orfit’s thermoplastic technology for use in patient immobilisation during delivery of targeted radiation treatment. The new material means devices such as the Nanor Mask can be designed to deliver enhanced patient comfort, treatment precision and environmental benefits.
FDA 510(k) Clearance for Varian’s ProBeam™ Proton Therapy System
Varian Medical Systems has received FDA 510(k) clearance for its updated ProBeam™ proton therapy system which the company claims minimizes proton therapy dose to healthy tissues that surround cancers.
Study Asks Whether Cook’s Esophageal Stent can be Removed
The prospect of removing an esophageal stent may be slightly daunting, but that’s what Cook Medical is investigating with a new US clinical study involving its supposedly retrievable new offering.
US and EU Nods for Boston Scientific’s Direxion™ Torqueable Microcatheter
Boston Scientific’s FDA cleared and CE mark approved new embolectomy catheter features a proprietary shaft design that the company says enables better control In hard-to-navigate Vessels.
FDA 510(k) Clearance for Varian’s RapidPlan™ Brings Knowledge-Based Treatment Planning to Radiation Oncology
Radiotherapy expert Varian Medical Systems has received 510(k) clearance from the U.S. FDA for a radiotherapy treatment planning tool designed to enhance quality, consistency, and efficiency in radiotherapy treatment planning.
FDA Clearance for CIVCO’s Protura™ System Means More Accurate Patient Positioning in Radiation Oncology
CIVCO Medical Solutions has gained FDA clearance of its Protura™ Robotic Patient Positioning System integration with Varian Medical Systems’ Motion Management Interface. The system delivers accurate patient positioning, one of the most important issues in radiation oncology
Real-Time Cervical Neoplasia Detection with Newly CE Marked Zedscan™ I Device
Zilico Ltd has gained CE Mark certification for its cervical cancer diagnostics device, ZedScan™ I. The UK company’s ground-breaking system offers quick, accurate detection of cervical neoplasia in real-time, enabling clinicians to improve patient management.
CE Mark for DFINE’s STAR™ Tumor Ablation System
Californian spinal technology company DFINE, Inc., has now received CE Mark approval for its STAR™ Tumor Ablation System for treatment of painful metastatic spinal tumors. The company officially launched the system in Europe at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress last month.
Ten minutes vs Ten days: CE Mark for World’s First Point-of-Care Multiple Myeloma Diagnostic Device
Rapid detection of Multiple Myeloma has to be a good thing, as this particular cancer deteriorates rapidly and has a poor prognosis. So the newly announced CE mark approval of a device that can do in ten minutes what currently takes ten days sounds like a guaranteed win.
FDA Clears AngioDynamics’ Thrombus-Reducing Ports
AngioDynamics, Inc. has announced the U.S. FDA 510(k) clearance through its subsidiary business Navilyst Medical Inc., for its BioFlo Port with Endexo technology, which is designed to reduce the accumulation of catheter-related thrombus on, and in, the port catheter.
Super-Accurate Prostate Monitor Reduces Uncertainty of Radiation Treatment
Swedish company Elekta AB has received CE marking for its Clarity® 4D Monitoring system permitting European clinics to implement this new way of reducing the uncertainty caused by prostate motion during radiation treatment. The device enables physicians to monitor the motion of the prostate with sub millimeter accuracy during the delivery of therapeutic radiation beams.