Devices
Philips Medical Systems has recalled (Class 1) the Forte Gamma Camera System due to a “nonconforming material/component.” The camera is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel. According to a recall notice, an
Devices
FDA has cleared a DiFusion 510(k) for the Xiphos-ZF Spinal interbody device. The device uses a new biomaterial called ZFuze, according to the company. Multiple studies have shown that the ZFuze material elicits pro-reparative M2 macrophage response and significant reductions in Interleukin 1-Beta and Interleukin 6,
Devices
FDA has cleared an Xact Robotics 510(k) for its robotic system and its use during computed tomography guided percutaneous interventional procedures. The company says its technology is the “first hands-free robotic system combining image-based planning and navigation with insertion and steering of various instruments to a desired
Devices
Thoratec Switzerland has recalled its CentriMag Acute Circulatory Support System Motor, which is a component of the CentriMag Extracorporeal Blood Pumping System, because of the potential for electromagnetic interference. A recall notice says that reports have been received about the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic
Devices
FDA has cleared a Stryker 510(k) for its Sahara Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology. The company says the 3D-printed lateral expandable fusion device “features passive expansion capabilities that are designed to allow surgeons to achieve up to 30 degrees of sagittal spinal correction
Devices
Sens. Elizabeth Warren (D-MA), Patty Murray (D-WA), and Tina Smith (D-MN) are raising additional questions on the CDRH software pre-certification program after receiving the 6/19 response from FDA acting commissioner Ned Sharpless and CDRH director Jeffrey Shuren to the senators’ initial 10/18/18 questions.
Devices
FDA is closing National Cybersecurity Awareness Month with a listing of key 2019 agency activities to ensure medical device cybersecurity safety and awareness. The post calls attention to these items: * convened a patient engagement advisory committee that sought recommendations on integrating medical device cybersecurity risk into health risk communications; * participated
Devices
FDA has granted Shreis Scalene Sciences a Breakthrough Device designation for Cytotron, a whole-body therapeutic medical device. The device is intended to be used to cause degeneration of uncontrolled tissue growth, the company says, and it is proposed for treating protein-linked, abnormally regenerating disorders such as neoplastic disease.
Devices
FDA says an Ethicon 10/3 recall 8,256 of its Echelon Flex Endopath staplers due to a failure to completely form staples is a Class 1 recall. The company says it recalled the devices because some of them may contain an out-of-specification component within the device jaw
Devices
Innovative Health Solutions is asking FDA not to make a determination of certain subject devices’ substantial equivalence to the IB-Stim without preclinical studies and at least one clinical trial establishing non-inferiority of the subject device to the IB-Stim in head-to-head evaluations. The 10/29 petition
Devices
FDA has granted Breakthrough Device status to Med-botics for its Oxalert EPO (Enhanced Pulse Oximeter) device. The wrist-worn “arousal” device is designed to prevent respiratory arrest and death from opioid overdose. It is intended to continuously monitor SpO2 (blood oxygen levels) in post-operative patients and at-home
Devices
FDA has approved an Impulse Dynamics PMA supplement for its next generation of the implantable Optimizer Smart System for delivering cardiac contractility modulation therapy in heart failure patients. “New algorithms in the two-lead version of Optimizer Smart deliver therapy just as the previous device did, but no longer require
Devices
CDRH Office of Gastrorenal, OBGYN, General Hospital and Urology Devices clinical deputy office director Charles Viviano says CDRH uses a flexible approach in assessing the impact of uncertainty on benefit-risk determinations for PMAs, de novo submissions, and HDEs. Speaking on a 10/16 Webinar on a new “uncertainty guidance,
Devices
Medtronic has received an FDA Breakthrough Device designation for its fully implantable left ventricular assist device (LVAD) for patients with advanced heart failure. Currently, LVAD systems include an implanted heart pump that is connected to a driveline cable that extends outside the body to a controller, which is connected to
Biologics
A Pew Trusts report, “FDA’s Framework for Regulating Regenerative Medicine Will Improve Oversight,” says the agency’s 2017 guidance documents that constitute its regulatory framework “marks an important step in the agency’s efforts to encourage the development of new therapies while also protecting patients from dangerous unapproved interventions.
Devices
FDA has cleared a HeartVista 510(k) to use its artificial intelligence-assisted One Click MRI acquisition software for cardiac exams. The clearance is based on data from a recent multi-center, outcome-based study (MR-INFORM), published in the New England Journal of Medicine, that “demonstrated that non-invasive
Devices
FDA has updated a 2018 safety alert about Endologix’s AFX endovascular graft systems used in treating abdominal aortic aneurysms (AAA) and the risks associated with Type III endoleaks with the devices. The new safety communication comes after the agency evaluated new information from recent real-world data, published in
Drugs
FDA has released a draft guidance on “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software.” A drug master file (DMF) is a voluntary submission that provides confidential detailed information about facilities, processes, or articles used in the manufacturing one or more human
Devices
FDA is growing concerned over recent closures of certain large-scale sterilization facilities that use ethylene oxide to sterilize medical devices prior to their use. “The recent closure of a Sterigenics ethylene oxide sterilization facility in Illinois, the temporary closure of another Sterigenics facility in Georgia, and the potential closure
Devices
Abiomed says that a post-approval study confirmed survival data in its pre-approval study for the Impella RP heart pump. “Nearly two years of real-world outcomes data on Abiomed’s Impella RP heart pump shows that when physicians followed the FDA’s approved protocol for Impella RP use
Devices
FDA has approved a Flowonix Medical PMA to market the Prometra II 40 mL Programmable Infusion Pump and its associated programmer software. The device has expanded reservoir size options to include both 20 mL and 40 mL pumps, and also includes a claim of a 10-year battery life at
Devices
FDA has granted Fresenius Medical Care a breakthrough device designation for its new hemodialysis system that aims to prevent blood clotting without the use of blood thinner medication in most patients. The antithrombogenic additive, Endexo, is being incorporated into the manufacturing process of dialyzers and bloodlines, the company says. Endexo