Devices
Maquet Datascope has recalled its CardioSave Hybrid Intra-aortic Balloon Pump due to a design issue that allows fluid (e.g., saline) to seep into the device. The fluid can corrode internal components (electronic circuit boards) that could lead to device malfunction and a delay or interruption of therapy, according
Drugs
FDA commissioner Scott Gottlieb says that a Biotech Working Group named last month is preparing an action plan with steps the agency will take to ensure it has a flexible regulatory framework for evaluating the safety of products that also supports plant and animal biotechnology innovation. Gottlieb made the comment
Devices
FDA has cleared a K2M Group Holdings 510(k) for its Ozark Cervical Plate Systems for anterior screw fixation to the cervical spine (C2-T1) in patients with degenerative disease, deformity, tumor, or trauma. The systems are available in two designs, Ozark Guide and Ozark View, both featuring an advanced
Devices
A 5/24 CDRH Webinar on two precision medicine guidances outlined major changes between the 2016 draft guidances and the final documents issued 4/13. During the Webinar, Adam Berger from the CDRH precision medicine staff, said the scope of the final guidance on design, development, and analytical validation of
Devices
FDA has published a draft guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, with an overview of the mechanisms available to submitters to request feedback from or a meeting with FDA on potential or planned medical device IDEs, PMAs, HDEs, De Novo requests, 510(
Devices
The CBER Office of Compliance and Biologics Quality says a Tiger Medical Web site is selling and distributing the Alere Determine HIV-1/2 Ag/Ab combo test kit without imposing the restrictions that are part of the kit’s approval. A 5/29 untitled letter says the agency’s
Devices
FDA has cleared a Rodo Medical 510(k) for the Rodo Smilekey, an induction remover device for use with the Rodo Abutment System. The device uses Rodo’s proprietary induction technology to remove dental prostheses retained by the Rodo Smileloc in less than 10 seconds without occlusal holes or damaging
Devices
FDA has completed its review of the agency-required Medifocus post-approval study of its Prolieve Thermodilation system. The company says the study involved 225 symptomatic benign prostatic hyperplasia (BPH) patients. The 12-year study with five-year follow-up data confirms long-term safety, efficacy, and durability of the
Devices
FDA has cleared an EOS Imaging 510(k) for its hipEOS 3.0 surgical planning software. The surgical planning software for total hip arthroplasty is part of the company’s EOSapps suite of online 3D surgical planning solutions (spineEOS, hipEOS, kneeEOS). The hipEOS 3.0 is intended to simulate the
Devices
FDA has cleared a Royal Philips 510(k) for the Ingenia Elition 3.0T magnetic resonance (MR) device and two clinical applications, Philips Compressed SENSE and 3D APT. The device and apps provide faster exam times and improved analytics to allow automatic planning, scanning and exam processing, the company says.
Devices
FDA has cleared a Spineology 510(k) for its Rampart One Standard ALIF interbody fusion system for use with or without supplemental fixation. The system includes both standard and oblique interbody devices, each with integrated fixation screws. The device is designed to minimize vascular retraction and exposure, the company says.
Devices
FDA is alerting health care providers about five additional deaths associated with the use of liquid-filled intragastric balloon devices for obesity treatment (see earlier story). “We have been carefully tracking adverse events, including a total of 12 deaths over the past two years, that have been reported in patients
Devices
FDA has cleared a Micronics 510(k) for its PanNAT STEC Test and its use in detecting Shiga toxin-producing E. coli. The test is performed in a disposable microfluidics-enabled cartridge and is a qualitative, in vitro nucleic acid amplification-based assay that simultaneously detects and differentiates the stx1
Devices
FDA has cleared a Medicrea Group 510(k) for patient-specific spinal cages through the extension of its UNiD ASI (Adaptive Spine Intelligence) technology to select from its IB3D range of 3D-printed titanium interbody devices. The clearance allows Medicrea to digitally plan, manufacture in-house and supply a 3D-
Devices
Medtronic has recalled its HeartWare Ventricular Assist Device (HVAD system) because of the possibility for an interruption to occur in the electrical connection between the system’s power source (battery, AC adapter, or DC adapter) and the HVAD controller. An interruption to the electrical connection, which occurs when the power
Devices
FDA has cleared a Branchpoint Technologies 510(k) for its Aura ICP Monitoring System, an implantable and wireless intracranial pressure (ICP) sensor that allows mobile ICP monitoring in brain-injured patients. The device enables continuous telemetric monitoring of parenchymal ICP including continuous ICP waveforms, the company says. It notes that
Devices
FDA has approved a MicroVention PMA for the LVIS and LVIS Jr. stents for stent-assisted coil embolization of intracranial aneurysms. The low-profile visualized intraluminal support device features a braided conformable, resheathable and retrievable design that provides high metal coverage and end-to-end device visualization to support the
Devices
FDA has published a draft guidance, Recommended Content and Format of Test Reports for Complete Non-Clinical Bench Performance Testing in Premarket Submissions, to describe relevant information that the agency wants included in complete test reports for non-clinical bench performance testing provided in a pre-market submission (PMA, HDE,
Devices
FDA has released the FDA-483 issued following a 4/9-4/24 inspection at Zimmer Biomet, Warsaw, IN. The 11 inspection observations were: * failing to adequately establish procedures for corrective and preventive action; * failing to adequately validate according to established procedures a process whose results cannot be fully verified
Devices
FDA has cleared a Neural Analytics 510(k) for its NeuralBot System, a robotic assistance technology which automatically adjusts orientation and position of its ultrasound products under the guidance of a healthcare professional. When used with its previously cleared Lucid M1 Transcranial Doppler Ultrasound System, the device is intended to
Devices
FDA has approved HumanOptics’ CustomFlex artificial iris, the first standalone prosthetic iris in the U.S. An agency news release says the surgically implanted device treats adults and children whose iris is completely missing or damaged due to aniridia or other damage to the eye. The CustomFlex product is made
Devices
FDA has started an “innovation challenge” to encourage development of medical devices, including digital health technologies and diagnostic tests, that could provide novel solutions to detecting, treating, and preventing addiction, addressing diversion, and treating pain. Companies selected by the agency to participate in the challenge will have an opportunity for