Devices
FDA has approved an Alucent Medical Phase 1 clinical trial of Natural Vascular Scaffolding (NVS), a novel combination drug/device therapy for treating peripheral vascular disease. The current standard of care for peripheral vascular disease relies on percutaneous balloon angioplasty, in which balloons are coated with known antiproliferative drugs such
Devices
FDA has cleared a Quidel 510(k) to market its Solana C. difficile Assay for the direct, qualitative detection of the Clostridium difficile DNA in unformed stool specimens from patients suspected of having such an infection. Unlike traditional methods for diagnosing C. difficile, such as glutamate dehydrogenase or toxin antigen
Devices
FDA has authorized use (humanitarian device exemption) of Cook Medical’s Flourish Pediatric Esophageal Atresia Anastomosis, a device to treat infants up to one year old for a birth defect that causes a gap in their esophagus, called esophageal atresia. Its use is only intended for infants who do not
Devices
FDA has cleared a NxStage Medical 510(k) for its next generation hemodialysis system, NxStage System One. The device features a new touchscreen user interface and integrated blood pressure monitor designed “to enhance ease of use for patients performing home hemodialysis,” the company says. “The touch screen interface provides an
Devices
FDA has cleared an NDS 510(k) for its new ZeroWire Mobile battery-powered display stand solution, which is intended to enable “untethered” clinical mobility of endoscopy displays. “ZeroWire Mobile eliminates the display power cord, which combined with ZeroWire wireless video, enables a streamlined, easy-to-use mobile imaging solution
Devices
A 16-member Healthcare Industry Cybersecurity Task Force says that FDA and other government agencies should consider how they can use existing authorities to “catalyze and reinforce activities and action items” associated with a task force recommendation to “increase adoption and rigor of the secure development lifecycle in the development
Devices
A 1/18-2/6 FDA inspection at Lonza Group, Basel, Switzerland, found Quality System Regulation violations in the firm’s work as a contract manufacturer of unidentified Class 2 medical devices. A 4/21 Warning Letter says that specific violations noted on an FDA-483 included: * failing, where the
Devices
CDRH is planning to establish a centralized digital health unit within the Office of the Center Director to ensure “proper coordination and consistency across the agency” for device-related apps and “software as a medical device (SaMD) issues.” Speaking last week at MedCon conference at Xavier University, CDRH associate director
Devices
FDA has cleared a Medrobotics 510(k) for the Flex Robotic System and its use for colorectal procedures. The company describes the flexible device as the world’s first robotic surgical platform to offer “scar-free” access to hard-to-reach anatomy in otolaryngology and colorectal procedures. Traditional surgical robots
Devices
Medtronic Mechanical Circulatory Support has expanded a Class 1 recall of its Ventricular Assist Device Controllers and DC Adapter to now include all controllers. The device helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from
Devices
FDA has approved a Cardiovascular Systems PMA supplement for a redesigned saline pump used as part of its Diamondback 360 Orbital Atherectomy Systems. The 70057-03 Saline Infusion Pump will replace CSI’s 7-10014 Saline Infusion Pump, which the company recalled last month. The company anticipates replacing all recalled
Devices
FDA says that the Medtronic 3/16 recall of all HeartWare Ventricular Assist System pump driveline spice kits distributed between 1/11/11 and 5/23/14 and used before 4/2015 is a Class 1 recall. An agency notice says that the device helps deliver blood from the heart
Devices
FDA has cleared an Interscope 510(k) for the EndoRotor System for use in gastroenterology and colorectal surgery. The device is intended for removing alimentary tract mucosa during colonoscopy. It resects and removes tissue simultaneously through a catheter inserted into the working channel of an endoscope. “Clinical data shows that
Devices
FDA has approved a Medtronic PMA for the Resolute Onyx Drug-Eluting Stent (DES) in 4.5 mm and 5.0 mm sizes to treat patients with large coronary anatomies. The company says the device is the first DES to feature core wire technology, a stent manufacturing method that involves
Devices
FDA says that ReFlow Medical is recalling specified lots of its Wingman35 crossing catheters. An agency notice says the catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. Tip splitting has the potential to lead to loss of device function, the notice
Devices
FDA has classified as Class 1 a recall of Newport Medical Instruments’ Newport HT70 and Newport HT70 Plus ventilators due to a software issue that may cause an unexpected shutdown without alarm. The devices are used to provide breathing support for individuals who require mechanical ventilation. An FDA recall notice
Devices
FDA has cleared a Luminex Corp. 510(k) for the ARIES Bordetella Assay for detecting and identifying of Bordetella pertussis and Bordetella parapertussis nucleic acid in nasopharyngeal swab specimens obtained from individuals suspected of having a respiratory tract infection attributable to either organism. The assay works on the company’s
Devices
A 3/6-3/29 FDA inspection at Unetixs Vascular, North Kingstown, RI, found violations of the Quality System Regulation in the firm’s manufacturing of vascular diagnostic ultrasound systems such as the MultiLab Series 2. A 4/25 Warning Letter says that significant violations included: * failing to establish and
Devices
Medtronic principal litigation counsel Max Heerman and Greenberg Traurig shareholder Daniel Smulian say that medical device company representatives should continue to be allowed in operating rooms because they “are a constructive presence, providing technical support to doctors and their staffs, and improving outcomes for patients.” Writing in a Washington Legal
Devices
FDA is warning users of Medtronic’s NavLock Tracker device not to use non-Medtronic surgical stereotaxic navigation instruments due to the potential for increased adverse events. The NavLock Tracker, an accessory to Medtronic's StealthStation Surgical Navigation System, enables navigation of instrumentation used during spinal fusion and interbody
Devices
FDA has cleared a Roche 510(k) for its cobas e 801 module for use on the cobas 8000 modular analyzer system. The module offers “greater testing efficiency, superior reagent management” and fast turnaround time for critical diagnostic tests, according to the company. “The cobas e 801 module almost doubles
Devices
FDA has cleared a Coapt 510(k) for its Complete Control System, described as an intuitive system for controlling advanced prosthetic arms. The company calls it the “first and only myoelectric pattern recognition system to be cleared for marketing in the United States... Its plug-and-play hardware seamlessly integrates