Devices
Integra LifeSciences says that a subsidiary 3/6 received an FDA Warning Letter blocking PMA approvals due to quality systems issues at a Boston manufacturing facility. The facility manufactures extracellular bovine matrix products. The letter was based on finding from a 11/2018 inspection and mirrored Form 483 observations that
Devices
FDA has granted Alcyone Lifesciences a breakthrough device designation for its ThecaFlex DRx System, an implantable subcutaneous port and intrathecal catheter used to provide access for cerebrospinal fluid aspiration and therapy infusion (intrathecal bolus administration). The company says the device is indicated for patients aged three years and above who
Devices
FDA has issued a letter to health care providers to alert them to an increasing number of medical device reports associated with surgical staplers for internal use and implantable surgical staples. In the coming months, CDRH will issue a draft guidance with safety labeling recommendations for manufacturers, according to a
Devices
FDA has cleared a Zeiss Medical Technology 510(k) for the Cirrus HD-OCT platform, expanding the capabilities of its anterior segment premier module to include epithelial thickness mapping. The device is designed to provide a detailed nine-millimeter map of epithelial thickness for assessing patients before refractive surgery, the
Devices
A lengthy Kaiser Health News investigative report says FDA is allowing medical device manufacturers to submit summary adverse event reports to databases that are kept from public view, hindering doctors and researchers who are trying to stay aware of issues with the devices. The report details issues with surgical staplers
Devices
The Medical Imaging and Technology Alliance (MITA) says it supports development of a regulatory system that both ensures the safety and efficacy of medical devices and reflects the real-world needs of the innovators and organizations bringing the technologies to market. Commenting on the FDA software precertification pilot program, MITA
Devices
FDA has granted Paige.AI, a start-up company that says it is developing computational pathology focused on artificial intelligence (AI) to transform clinical diagnosis and cancer treatment, a breakthrough device designation. “Paige.AI is focused on providing artificial intelligence tools to pathologists that will enable them to become faster
Devices
FDA has updated a 1/18 safety alert that warned health professionals about Zoll Medical’s Zoll LifeVest 4000 Wearable Cardioverter Defibrillator due to concerns that it may fail to deliver treatment if it is not replaced soon after displaying a “call for service” message code 102. Failure to contact
Devices
FDA has cleared a CurvaFix 510(k) for the CurvaFix Intramedullary Rodscrew for use in pelvic trauma surgery. The rodscrew is a flexible device that is implanted through a small skin incision into the intramedullary space (center of the bone) and then converted into a rigid state to stabilize and
Devices
FDA has cleared an Instrumentation Laboratory 510(k) for the GEM Premier ChemSTAT in vitro diagnostic (IVD) analyzer with Intelligent Quality Management. The device is designed for rapid basic metabolic panel testing at the point of care. The company says it provides laboratory-quality results in less than 70 seconds,
Devices
RVO 2.0 has recalled its Raindrop Near Vision Inlay because data from a post-approval study showed an increased risk of corneal haze (a type of cloudiness in the cornea due to inflammation) associated with the device. The device is now owned by RVO 2.0, doing business as
Devices
AdvaMed says two FDA draft guidances on self-monitoring blood glucose test systems for over-the-counter use and prescription point-of-care use will “support accurate, reliable blood glucose monitoring test systems while also providing for innovation and continued investment in new technology.” In comment letters here (over-the-
Devices
FDA says it is soliciting comments on a proposal to exempt some flow cytometer instruments from 510(k) premarket notification requirements. A 3/6 Federal Register notice says the agency has determined, based on established factors, that the devices no longer require premarket notification to provide reasonable assurance of safety
Devices
FDA has cleared an eNeura 510(k) for its single-pulse Transcranial Magnetic Stimulation (sTMS) device and expanded use in acute and preventive treatment of migraine to include children 12 years of age and older. The company received clearance for acute and preventive treatment of migraine in adults in 2017.
Devices
FDA has cleared a Safe Medical Design 510(k) for the Signal Catheter, a urinary catheter that is designed to reduce urethral trauma caused by premature balloon inflation during placement. The company says that there are 30 million urethral catheters annually used in the U.S., with up to 500,
Devices
FDA has issued a safety alert on using robotically-assisted surgical devices in women’s health procedures, including mastectomy and other cancer-related surgeries. The alert says that the safety and effectiveness of these devices in such cases has not been established. “There is limited, preliminary evidence that the use
Devices
Physio-Control has begun a Class 1 recall of its LifePak 15 monitor/defibrillator because the device may “lockup” (freeze) after a shock is delivered. “When this occurs, the device’s monitor display goes blank and there is no response from the keypad or the device although the device’s
Devices
FDA says it is monitoring the impact on medical device supply issues and potential shortages arising from a seal order issued by the Illinois Environmental Protection Agency to the Sterigenics Willowbrook product sterilization facility that resulted in the facility ceasing operations. An online CDRH message says medical devices accounted for
Devices
FDA has cleared a Medtronic 510(k) for the Accurian RF ablation platform for use in radio frequency ablation of nerve tissues for treating pain. The device “combines proprietary hardware and quad core processing with advanced software for power and temperature control resulting in consistent and predictable lesion formation,” the
Devices
FDA is joining the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services to launch a tri-agency task force to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public
Devices
FDA has cleared a Sensus Healthcare 510(k) for the Sculptura radiation oncology system, a single radiation treatment used during cancer surgery. The robotic intraoperative radiation therapy system uses patented Beam Sculpting capabilities to treat various cancers during surgery. The first device has been installed at the University of Pennsylvania&
Devices
FDA has issued a Warning Letter to Total Thermal Imaging (La Mesa, CA) for illegally marketing and distributing an unapproved thermography device as a sole screening device for breast cancer and other diseases. The agency also issued a safety communication to warn patients that thermography is not cleared as an