Drugs
Drug recalls decreased 18.1% to 77 in the second quarter of 2019, tied for the second lowest number over the past 10 quarters, according to the Stericycle Quarter 2 recall index. However, the report says that recalled units increased 86.3% to just under 24 million, almost double the
Devices
A 3/11-3/28 FDA inspection at Talon, an S&S Technology company, in Houston, TX, found Quality System Regulations violations, including several repeated from a 2011 inspection, in the firm’s manufacturing of Class 1 and 2 medical equipment, healthcare supplies, and radiation products used for general
Devices
FDA has cleared a DynoSense 510(k) for its Vital Signs Measuring System, a cloud-based measuring and recording platform. The device captures electrocardiogram, respiration rate, oral body temperature, functional oxygen saturation of arterial hemoglobin, optical photoplethysmogram for pulse rate, and heart rate data. The company says it wirelessly communicates
Devices
FDA has cleared a SpineWelding 510(k) for its Elaris Pedicle Screw System, which is intended to provide immobilization and stabilization of spinal segments through posterior, non-cervical, pedicle fixation in skeletally mature patients as an adjunct to fusion. The device is indicated for use in treating degenerative disc disease,
Devices
FDA has cleared a Shimadzu Medical Systems 510(k) for the Fluorospeed X1 patient side conventional radiographic/fluoroscopic (RF) table system. The device offers high image bariatric and routine daily fluoroscopic and radiographic exams, according to the company, including chest, abdomen, or extremities along with upper GI’s, modified swallows
Devices
Fresenius Kabi has recalled its Volumat MC Agilia Infusion Pumps and Vigilant Agilia Drug Library due to a “low priority — keep vein open, end of infusion” alarm and multiple software errors. “When enabled, the ‘keep vein open, end of infusion’ alarm triggers when the infusion is complete,” a recall notice
Devices
FDA has given Endologix the green light to begin a pivotal study to evaluate the safety and effectiveness of its Nellix Chimney EndoVascular Aneurysm Sealing System and its use for the endovascular treatment of complex abdominal aortic aneurysms (AAA). The device combines the company’s Nellix 3.5 endograft with
Devices
FDA says that because of ongoing concerns about a late mortality signal in patients treated for peripheral artery disease in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents, it is working with manufacturers working on updated device labeling and clinical trial informed consent documents. In an 8/
Devices
FDA has cleared a NinePoint Medical for the NvisionVLE Imaging System for use in the pancreas and bile duct. These anatomical indications add to the existing esophageal applications for NinePoint’s optical coherence tomography imaging platform. The device provides physicians “real-time, high-resolution volumetric images of the tissue surface
Devices
FDA has issued a Request for Information (RFI) to identify potential parties capable of providing computational human heart modeling software and services to conduct simulations and studies. The RFI says the CDRH Division of Applied Mechanics in the Office of Science and Engineering wants to identify vendors with the capability
Devices
FDA has cleared a Mt. Derm 510(k) to expand the use of its Exceed microneedling device for treating acne scarring. Previously, the device was cleared for treating facial wrinkles. The new clearance was based on data from a clinical study that evaluated the device’s efficacy and safety when
Devices
Legislation is needed to codify changes FDA is seeking to its medical device 510(k) program to reduce the reliance of equivalence to a predicate device and transition to a system where new devices demonstrate improved safety and effectiveness compared with marketed devices for the same clinical purpose, according to
Devices
Abbott has recalled its Ellipse Implantable Cardioverter Defibrillators (ICDs) after electrical failures had been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed. This makes them prone to electrical shorting of the capacitor, a recall notice says. If a short
Devices
FDA has cleared a Medicrea Group 510(k) for its Tulip Genesis for use with the UNiD Adaptive Spine Intelligence platform technology. Tulip Genesis is described by Medicrea as a state-of-the-art comprehensive top loading screw system that offers solutions for both degenerative and complex deformity spinal cases.
Devices
Qiagen has recalled filter tips used with the QIAsymphony SP/AS instruments due to their potential to leak, which may result in delayed or inaccurate results. The pipetting system filter tips are used for clinical assay workflows or with in vitro diagnostic tests. “Due to a manufacturing malfunction resulting in
Devices
Teleflex has recalled certain Sheridan endotracheal tubes and connectors, which are also used in Centurion’s convenience kits. “Teleflex recalled multiple models of the Hudson RCI Sheridan and Sheridan endotracheal tubes due to reports of the Sheridan endotracheal tube connector dislodging from the endotracheal tube, causing disconnection of the patient
Devices
FDA has granted B. Braun Interventional Systems a breakthrough device designation for the SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty balloon catheter for treating coronary in-stent restenosis. SeQuent is the latest generation coronary drug-coated balloon catheter developed by B. Braun. The company says the designation is
Devices
FDA has issued a draft guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, with the agency’s recommendations on testing to assess the safety and compatibility of medical devices in the magnetic resonance environment. The document also has the recommended format for magnetic resonance
Devices
FDA and France’s Dassault Systèmes will extend their collaborative research agreement for five years with an aim to spur medical device innovation by enabling innovative, new product designs. The company says its 3DEXPERIENCE platform “will be used to develop a new digital tool to enable more efficient regulatory review
Devices
FDA has cleared a PhysIQ 510(k) for use of the company’s algorithm to continuously determine respiration rate in ambulatory patients. The clearance adds to PhysIQ’s current portfolio of FDA-cleared cloud-based analytics, which also include heart rate, heart rate variability, atrial fibrillation detection, and a personalized
Devices
FDA has cleared a Solio 510(k) for its Alfa Plus, intended for use in relieving chronic pain in addition to pain from trauma, sports injury and menstruation. The radio frequency (RF) device is designed for home use and uses a combination of RF, infrared technologies and low-level laser
Devices
FDA has cleared 510(k)s for four previously cleared Zeus Scientific tests with new indications to aid in diagnosing Lyme disease. The tests represent the “first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run