Devices
FDA has approved Boston Scientific’s Acuity X4 Quadripolar Left Ventricular (LV) leads. “The FDA approval of the quadripolar leads, the wires that connect cardiac resynchronization therapy (CRT) devices to the heart, marks the first time the company will offer a full X4 CRT system – both the device and the
Devices
FDA’s Orthopedic and Rehabilitation Devices Panel has voted 7 to 4 not to recommend approval of a Medtronic PMA for the DIAM Spinal Stabilization System for use in skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than one
Devices
FDA says Pentax has issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labeling. The agency says that it reviewed reprocessing instructions and the validation data and recommends that facilities using the devices should train staff on the them
Devices
FDA has cleared a ScandiDos 510(k) for the Delta [4] Discover, a device that independently verifies the radiation dose delivered to a patient during radiation treatment. “Until now, the concept of measuring the daily dose of radiation in real time, to ensure it accurately matches the patient treatment plan,
Biologics
A lengthy and detailed report from the George Mason University Mercatus Center says that FDA has strayed from the drug, biologic, and medical device safety and effectiveness standards set out in the law due to “fear of being blamed for the failings of approved products.” The agency now, it says,
Devices
FDA has approved Medtronic’s Deep Brain Stimulation (DBS) therapy for use in people with Parkinson’s disease of at least four years duration and with recent onset of motor complications, or motor complications that are not adequately controlled with medication. The device was originally approved in 2002 for use
Devices
Bayer has disputed allegations leveled by Rep. Mike Fitzpatrick that a new report (see story) revealed unreported fetal deaths associated with the company’s controversial Essure permanent birth control device. On 2/17, Fitzpatrick released the report that cited 303 fetal deaths allegedly associated with the device, which he says
Devices
FDA has approved a St. Jude Medical PMA for the MultiPoint Pacing technology featured on the Quadra Assura MP cardiac resynchronization therapy (CRT) defibrillator, the Quadra Allure MP CRT-pacemaker and two new quadripolar Quartet LV leads. St. Jude says the new technology is designed to benefit CRT patients who
Devices
An FDA 2/18 final order says that manufacturers will have to submit a PMA application for two types of metal-on-metal (MoM) total hip replacement devices. Affected are the hip joint metal/metal semi-constrained with a cemented acetabular component, and the hip joint metal/metal semi-constrained
Devices
Rep. Mike Fitzpatrick (R-PA) has asked CDRH director Jeff Shuren to review a new report identifying 303 fetal deaths allegedly associated with Bayer Health’s controversial Essure permanent birth control device. The congressman says that CDRH’s previous public materials related to Essure have cited five reports of fetal
Devices
CDRH has objected to plans for Sure Genomics to market its SureDNA test to consumers. The test, according to the company’s Web site, is intended to collect saliva samples and perform DNA sequencing and reporting of patient information, such as disease risks and likelihood of drug reactions. In a
Devices
The Medical Alley Association, which advocates for Minnesota healthcare industry companies and individuals, says that 510(k) clearances declined 26% in 2015 to their lowest point in five years. At the same time, it says, comparable clearances outside the U.S. rose 51%. The group’s annual approval report also
Devices
FDA has cleared a Zimmer Biomet Holdings 510(k) for the Unite3D Bridge Fixation System, a 3D-printed technology designed to offer stability in foot and ankle arthrodesis (joint fusion) surgery. The company says its OsseoTi porous metal technology mimics the architecture of cancellous bone and the Unite3D serves as
Devices
FDA has cleared an Optovue 510(k) for the AngioVue Imaging System, a dyeless technique for quickly visualizing abnormal blood vessels in the retina to help physicians determine an appropriate treatment course. “In less than three seconds, the AngioVue System acquires a single image that complements the current angiography imaging
Devices
FDA has issued a draft guidance, Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices, to assist industry members who submit orthopedic devices using ultrahigh molecular weight polyethylene material to determine the appropriate information and testing to submit in 510(k)s, de novo requests, PMA applications, HDEs,
Devices
FDA has cleared a Guerbet 510(k) for its OptiOne Single-Head Contrast Delivery System for CT imaging procedures. The device, which is available in ceiling-suspended and pedestal form, is designed for injecting radiopaque contrast agents in the vascular system to obtain diagnostic images in CT scan examinations. Each
Devices
FDA has cleared a Wenzel Spine 510(k) to market VariLift-LX as an interbody fusion device for stand-alone use in the lumbar spine. The device is designed to “simplify” to be implanted in a unilateral or bilateral capacity, it says. It has four large fenestrations and a bone
Devices
Cook Medical has recalled 360 lots of its Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays due to catheter tip fractures or separations. Globally, 17,827 devices are subject to the recall, according to a recall notice. The products are intended for use in venous or arterial
Devices
A Nevada federal grand jury has indicted Dmitriy Melnik on one count of conspiracy to traffic in counterfeit goods and to introduce into interstate commerce misbranded devices, four counts of trafficking in counterfeit goods, and five counts of introducing misbranded devices into interstate commerce. A Justice Department news release says
Devices
FDA has cleared an MX Orthopedics 510(k) for the dynaMX Compression Staple for fracture fixation. The device, which is made of “superelastic nitinol,” allows the surgeon to control the opening of staple legs, according to the company. There is no post-insertion tamping required, and it allows easy intraoperative
Devices
FDA has cleared a Becton Dickinson 510(k) for the BD FACSPresto system and BD FACSPresto CD4/Hb Cartridge for use in testing CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples to manage HIV/AIDS patients. The automated multicolor fluorescent imaging cytometer and absorbance spectrometer provides absolute
Devices
Public Citizen says that a provision in the 21st Century Cures legislation that would encourage FDA to rely on articles published in peer-reviewed journals to determine the effectiveness of a medical device is a bad idea. In its second report on specific provisions of the legislation, Public Citizen says