Devices
The Case for Quality, a collaboration between FDA, the medical device industry, healthcare providers, and quality experts, is examining the feasibility and effectiveness of using standardized medical device performance data and analytic techniques to help hospitals better compare and evaluate product quality. The multi-year Case for Quality initiative is
Devices
FDA has cleared a BioFire Diagnostics 510(k) for the FilmArray Respiratory Panel EZ. The device is intended for use in detecting 11 viral and three bacterial pathogens associated with respiratory infections from a single patient sample. It is designed to run on the FilmArray 2.0 system and provides
Devices
FDA says that internal analyses on the use of Alere’s faulty blood testing devices (INRatio and INRatio 2 PT/INR) had a “minimal” impact on a clinical trial involving Johnson & Johnson’s blood thinner Xarelto. “The agency has determined that effects on strokes or bleeding, including bleeding in
Drugs
Rep. Ron DeSantis (R-FL) has introduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act of 2016 (H.R. 6241), to provide for reciprocal marketing approval of certain drugs, biological products, and medical devices that are authorized to be lawfully marketed abroad but not in the U.S.
Devices
An FDA safety communication says that St. Jude Medical has issued an advisory on implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator batteries that may fail earlier than expected. FDA and the company are alerting patients, patient caregivers, and doctors to respond immediately to elective replacement indicator alerts on the
Devices
FDA has cleared a St. Jude Medical 510(k) for the PressureWire X Guidewire fractional flow reserve (FFR) measurement system, which is designed to offer improved shapeability and better shape retention aimed at reducing vessel trauma during percutaneous coronary intervention procedures. The measurement system is intended for use by physicians
Devices
A citizen petition from the law firm Wood, Herron & Evans urges FDA to detain Magnacoustics’s MagnaTouch MRI Music System, Genesis Ultra MRI Music System and MagnAlarm because they are not cleared by the agency under a 510(k). The petition says the devices are “clearly accessories to magnetic
Devices
FDA has cleared a Teleflex 510(k) to market its Arrow JACC with Chlorag Technology and TightTrack tunneler, a small french-size antithrombogenic and antimicrobial central venous catheter designed to meet the needs of patients throughout their course of therapy or illness. The device is also designed for use with
Devices
FDA needs to stop delaying a “a much-needed – and supposedly top priority – guidance” on clinical decision-support software, according to Clinical Decision Support Coalition counsel and Epstein Becker & Green partner Bradley Merrill Thompson. The agency has been working on the guidance for five years, but it still hasn’
Devices
FDA has released a guidance on “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” that describes studies and criteria that FDA recommends be used when submitting 510(k)s for such devices. The document is intended to guide manufacturers in conducting appropriate performance studies and preparing submissions.
Devices
FDA has approved a St. Jude Medical PMA for the Infinity Deep Brain Stimulation (DBS) system and its DBS directional leads, which the company describes as the first directional lead approved in the U.S. The device is intended to treat two of the most common movement disorders — Parkinson’s
Devices
FDA has posted a guidance on “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use” that describes studies and criteria the agency recommends when submitting 510(k)s for such devices. The document is intended to guide manufacturers in conducting appropriate performance studies and preparing submissions. The guidance
Devices
FDA has cleared an Adapta Medical 510(k) for the PerfIC Cath intermittent touchless urinary catheter. It is designed for those with a spinal cord injury, multiple sclerosis, diabetes, stroke, spina bifida or other conditions that require a catheter. The device features a patented gripping accessory and hydrophilic coating to
Devices
FDA has cleared a Fresenius Kabi 510(k) for the Aurora Xi Plasmapheresis System for use in collecting plasma. “The Aurora Xi system features a proprietary filtration-separation method that enables the faster collection of Source Plasma,” the company says. The device also includes an interactive touch screen, data management
Devices
FDA has cleared a Trice Medical 510(k) for mi-eye 2, a disposable needle with an integrated camera that enables physicians to use advanced diagnostic imaging to visualize joint injuries in their clinic. The device is designed for use in diagnostic and operative arthroscopic and endoscopic procedures to provide
Devices
FDA has cleared a Xenocor 510(k) for the Xenoscope, a single-use disposable laparoscope that will be offered in a sterile condition. The device provides high-definition, real-time image acquisition, and is designed to be used in remote and extreme environments without a power grid, according to the
Devices
FDA has cleared a Viveve Medical 510(k) for the Viveve System for use in general surgical procedures for electrocoagulation and hemostasis in treating vaginal laxity. The device uses patented radiofrequency (RF) energy to stimulate the body’s natural collagen rebuilding processes in the vagina. A physician performs the procedure
Devices
Vascular Solutions has begun a Class 1 recall of its Twin-Pass Dual Access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. It is possible that this material may separate
Devices
CDRH evaluates submitted patient preference information as valid scientific evidence along with other evidence from clinical and non-clinical testing when making benefit/risk determinations, according to Office of Surveillance and Biometrics associate director for quantitative innovation Martin Ho. He was one of two Center presenters on a 9/27
Devices
FDA has cleared an Etiometry 510(k) for its Risk Analytics Algorithm that is intended to inform physicians and nurses in the intensive care unit about a patient’s condition. The algorithm is for use with the company’s T3 Visualization & Data Aggregation software. The Inadequate Oxygen Delivery (IDO2)
Devices
FDA has approved a St. Jude Medical PMA for the BurstDR stimulation, a physician-designed spinal cord stimulation (SCS) for treating chronic pain. BurstDR stimulation “works differently from other stimulation designs, utilizing intermittent ‘burst’ pulses designed to mimic the body’s natural nerve impulse patterns,” the company says. Approval was
Devices
A 11/9-11/25/15 FDA inspection at Collagen Matrix in Oakland and Franklin Lakes, NJ, found that the firm’s Zcore porcine xenograft particulate in syringe device is adulterated because it doesn’t comply with Quality System Regulations covering current good manufacturing practice. A 9/20 Warning Letter