Xenocor’s Single-Use Laparoscope Receives CE Mark
Xenocor has received the CE Mark for the Xenoscope systems, which are single-use laparoscopes.
The device is used in diagnostic and therapeutic procedures for digestive track surgery within the thorax and abdominal cavities, including the female reproductive organs.
This single-use device is designed to improve flexibility while providing HD visualization of the anatomy.
Genedrive Gains CE-IVD Certification for Human Genotyping Test
Genedrive has announced the CE-IVD certification of its rapid Genedrive IL28B SNP human genotyping test.
The device performs a 50-minute test with an inner-cheek swab sample using the Genedrive mobile real-time PCR instrument.
The Genedrive IL28B test was developed alongside the Genedrive HCV test which is scheduled for market launch in 2017.
Prytime Medical Devices Receives CE Mark
Prytime Medical Devices received CE Mark approval for its ER-Reboa Catheter and has begun preparation for a targeted market release in Europe.
The device is designed for temporary occlusion of large vessels by using a balloon catheter.
The company expects to begin its European distribution by early 2017.
LimFlow’s Stent Graph System Receives CE Mark
LimFlow has received the CE Mark for its LimFlow Graph Stent System designed to increase blood flow to the lower limbs in patients at risk of limb amputation due to ischemia.
The LimFlow Stent Graft System consists of four main components: an arterial ultrasound catheter with needle, a venous ultrasound catheter, a covered nitinol stent in a delivery system and an ultrasound system.
This device is used to bypass diseased arteries and divert blood flow into the tibial vein in order to increase blood flow to the entire ischemic foot.
Channel Medsystems Secures IDE Approval and for the Clarity Pivotal Study
Channel has revealed the treatment of the first subjects in the US phase of its Clarity Pivotal Study, which was to evaluate the safety and effectiveness of the Cerene Cryotherapy Device for endometrial ablation in women with heavy menstrual bleeding who are finished with childbearing.
The device was designed to provide an analgesic effect.
Treatment with cryothermic energy has been shown to reduce the likelihood of scarring and intrauterine adhesions that are often associated with heat-based endometrial ablation.
HeartWare Issues Recall for Ventricular Assist Device Controllers
HeartWare has recalled the HVAD controller due to a loose power connector, which may cause the rear portion of the pump’s driveline connector to become separated from the front portion of the driveline connector.
The HVAD delivers blood from the heart to the rest of the body and is used in patients who are at end-stage left ventricular heart failure and who are waiting for a heart transplant.
The devices were manufactured between September 30, 2014 and February 29, 2016.
Premarket Review Timeframes Improve for Japanese Medical Devices
The Pharmaceutical and Medical Devices Agency (PMDA) has reported steady reductions in review times for Class II and III pre-market approvals between fiscal years 2010 and 2014, and also in late 2015. A report was compiled and showed similar trends.
The following review timeframes are to be reached by 2018: new devices will take 9-12 months for fast-track Yusenshisa applications; improved devices with clinical data will take 9 months; improved devices without clinical data will take 7 months; and generic devices will take 5 months.
InspireMD Gains Commercialization Approval in Russia for CGuard
InspireMD has received regulatory approval to commercialize the CGuard Embolic Prevention System (EPS) for the treatment of carotid artery disease in Russia.
The CGuard EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining perfusion to the external carotid artery.
CGuard EPS is CE Marked and not approved for sale in the U.S. by the FDA at this time.
Cardiovascular Systems Signs Distribution Agreement with Medikit for Japan
Cardiovascular Systems has signed a distribution agreement with Medikit to sell its Diamondback 360 Coronary and Peripheral Orbital Atherectomy Systems (OAS) in Japan.
Cardiac Systems has submitted its application for Shonin approval of the Coronary OAS Micro Crown following the completion of the Coast clinical study which evaluated the safety and efficacy of Cardiac Systems’ OAS in treating patients with severely calcified coronary lesions.
The company completed Coast enrollment of 100 patients in July 2015.
Data was presented from the study showed a 30-day freedom from major adverse cardiac events rate of 85 percent and a successful stent delivery rate of 99 percent.
Parexel Launches IDMP-Focused Software and Service Solution
Parexel has launched an Identification of Medicinal Products (IDMP)-focused solution for biopharmaceutical companies.
Liquent InSight for IDMP is the newest module added to Parexel’s Regulatory Information Management platform.
The company’s software allows biopharmaceutical companies to collect their data in a comprehensive and holistic manner.
It is compliant with the five ISO IDMP standards defining product and registration data and details for investigational and registered medicinal products.
Inscopix Launches an “All-Optical” Brain Mapping Platform
Silicon Valley-based, Inscopix, has revealed their microscopic brain-imaging device, nVoke.
nVoke is a combination device that illuminates modified neurons to show calcium ion channels., into a single “all-optical” platform for precise measurement and modulation of brain activity.
This device is designed for observing the relationship between electrical pulses in nerve cells and their behavior as well as deciphering the interactions between groups of neurons within and across brain regions.