Aethlon Medical, Inc. has announced that the U.S. FDA has approved an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier® in the country. The Hemopurifier targets the rapid elimination of life-threatening infectious disease and cancer glycopathogens from circulation.
Oncology
Prostate IDE For AngioDynamics’ NanoKnife System
MIS device company AngioDynamics has announced the U.S. FDA’s Investigational Device Exemption (IDE) approval to conduct a clinical study of the NanoKnife System for the ablation of focal prostate cancer.
Trial Will Test SurgiMend® PRS Breast Cancer Reconstruction Claims
TEI Biosciences, Inc. has gained FDA Investigational Device Exemption (IDE) approval to initiate a human clinical trial to gain specific … continue reading “Trial Will Test SurgiMend® PRS Breast Cancer Reconstruction Claims”
FDA Clears iCAD’s Cervical Applicator For Xoft Electronic Brachytherapy System
iCAD, Inc., has received U.S. FDA clearance for its new cervical applicator for use with its Xoft® Axxent® Electronic Brachytherapy System® to deliver high dose rate brachytherapy for intracavitary treatment of cancer of the uterus, cervix, endometrium and vagina.
Dune’s MarginProbe® System Aims To Improve Lumpectomy Outcomes
Dune Medical Devices, Inc. announced today the MarginProbe System, a breakthrough intra-operative tissue assessment device used during lumpectomy surgery to treat early-stage breast cancer, is now available to patients in the United States.
FDA Clears Smith Medical’s CADD®-Solis VIP Ambulatory Infusion System
Smiths Medical has announced FDA 510(k) clearance for its CADD®-Solis VIP ambulatory infusion system with CADD™-Solis medication safety software. This multi-therapy pump includes applications from TPN to chemotherapy, antibiotics, hydration and pain management with intuitive, easy to use navigation and features inbuilt safety measures.
German Reimbursement For Delcath’s Chemosat Liver Cancer Drug Delivery System
Delcath Systems, Inc. has announced that the Institut für das Entgeltsystem im Krankenhaus (InEk), the German federal reimbursement agency, has established a reimbursement pathway for the treatment of patients with liver metastases with the Delcath Hepatic CHEMOSAT® Delivery System for melphalan hydrochloride.
FDA Clears Varian’s Edge™ Radiosurgery Suite For Non-Invasive Surgical Procedures
Varian Medical Systems has received FDA 510(k) clearance for the company’s Edge™ radiosurgery suite, a new dedicated system for performing advanced radiosurgery using innovative real-time tumor tracking and motion management technologies.
FDA 510(k) Clearance for Varian’s Vitesse™ Brachytherapy Treatment Planning Software
Varian Medical Systems has gained FDA 510(k) clearance for the latest version of its Vitesse™ real time planning for high dose rate (HDR) brachytherapy which is used to plan and perform HDR, ultrasound-guided brachytherapy treatments for prostate cancer.
FDA Approves Devicor’s Mammotome® revolve™ Biopsy System
Devicor® Medical Products, Inc. has announced that the US FDA has approved Mammotome® revolve™, a dual vacuum-assisted biopsy system, for use on patients.
Non Invasive Ultrasound Therapy For Breast Fibroadenomas A Reality As Ultrasound Device Gains CE Mark
Paris-based ultrasound therapy specialist, Theraclion, has gained CE mark approval for its non-invasive treatment of breast fibroadenomas, a first in this indication. The company expects this treatment to benefit thousands of women.
FDA Clears GE’s “FlightPlan for Liver” Embolization Planning Device
Very clever inbuilt technology means GE Healthcare’s “FlightPlan For Liver” can help physicians identify which vessels to embolize when isolating liver tumors. The newly approved product is being showcased at Radiology Society Of North America meeting this week.
FDA 510(k) Clearance For Accuray’s CyberKnife® M6™ Series
Accuray company, today announced that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new CyberKnife M6(TM) Series. The CyberKnife M6 Series features expanded clinical capabilities, reduced treatment times and an enhanced patient experience.
Varian Medical Systems Highlights Its Comprehensive Product Portfolio for the Non-Invasive Treatment Of Lung Cancer
Varian Medical Systems has been showcasing the company’s technologies for the non-invasive treatment of lung cancer at the 54th annual meeting of the American Society for Radiation Oncology (ASTRO) in Boston this week.
FDA 510(k) Clearance For Thermedical™ RF Ablation System For Larger Tissue Volumes
Thermedical™, a medical equipment company developing new tissue-ablation therapies, has received U.S. FDA clearance to market its innovative technology for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
Varian Medical Systems Unveils EDGE™ Radiosurgery Suite
Varian Medical Systems has unveiled its next move against cancer, the new EDGE™ Radiosurgery Suite — a fully integrated dedicated system for performing advanced radiosurgery using new real-time tumor tracking technology and motion management capabilities.