Devices
FDA has extended its review of a Nuvectra PMA for its Virtis Sacral Neuromodulation system. “FDA has informed us that they have not yet concluded their review and as such will require an extension of our 180-day review period,” the company says. “To date, FDA has not identified any
Devices
FDA has cleared a XableCath 510(k) for its Peripheral Crossing Catheters, intended for use to cross challenging lesions in both arterial chronic total occlusions and chronic obstructive venous lesions. The device’s clearance is based on data demonstrating a 95% success rate in crossing arterial lesions and 100% success
Devices
The Healthcare and Public Sector Coordination Council Joint Cybersecurity Working Group, of which FDA is a member, has produced a Joint Security Plan (JSP) to address cybersecurity challenges in using software-based medical technologies. The document says the challenges include but are not limited to transparency and disclosure between vendors
Devices
FDA has approved a Kurin 510(k) for its Kurin PIV18 peripheral IV (PIV) configuration with an extension set, which is intended for use with infusions. Many blood cultures are taken via direct venipuncture. By adding an extension set to a previously-available PIV product, nurses can leave the set
Drugs
FDA commissioner Scott Gottlieb says the agency is undertaking additional activities to advance the opportunity to use real-world data (RWD) and real-world evidence (RWE) for the benefit of patients. In a 1/28 speech to the Bipartisan Policy Center Conference, he outlined the activities as: * supporting the seamless
Devices
FDA has cleared a MediPines 510(k) for the MediPines Gas Exchange Monitor, which is intended for real-time pulmonary parameters and insights to support rapid triage and treatment decisions for respiratory conditions. The device is designed to “integrate a comprehensive set of respiratory parameters and innovative indices analyzed from
Devices
FDA has extended by 30 days the comment period for a 12/2018 public workshop and a related white paper, Evaluating Whether Activities Are Servicing or Remanufacturing. Comments, which now are being accepted until 2/25, will be used by FDA to inform future guidance on the topic. The white
Devices
FDA has approved an expanded use for AbbVie’s Imbruvica (ibrutinib) — combination use with Gazyva (obinutuzumab) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The latest approval expands Imbruvica’s use as a single agent or in combination with bendamustine and rituximab for adult
Devices
CDRH approved a record 106 novel devices last year, eclipsing the 40-year record it set in 2017 when 99 such devices were approved. The agency also granted 112 breakthrough device designation requests since the start of the program in 4/2015, and in 2018 it approved or cleared nine
Devices
FDA has announced a 3/25-26 General and Plastic Surgery Devices Panel meeting to discuss topics concerning the benefit-risk profile of breast implants. The agency plans to publish a Federal Register notice and agenda on its Advisory Committee Calendar Web page 15 days in advance of the meeting.
Devices
Centerline Biomedical has submitted a 510(k) for its Intra-Operative Positioning System (IOPS), a non-radiation-based surgical navigation system. The device is intended to leverage anatomical mapping and modeling algorithms and electromagnetic tracking technology to provide three-dimensional color visualization and real time guidance during endovascular procedures, the
Devices
Draeger Medical has recalled (Class 1) its VentStar and ID Breathing Circuits and Anesthesia Sets manufactured 1/2016 to 11/2018 due to incorrect assembly concerns. The single-use, disposable, accessory devices are used with a ventilator or anesthesia machine to provide mechanical ventilation and critical breathing support to infant,
Devices
FDA has cleared a Zimmer Biomet Holdings 510(k) for the Rosa Knee System for robotically-assisted total knee replacement surgeries. The device, according to the company, features 3D pre-operative planning tools and “real-time, intraoperative data on soft-tissue and bone anatomy designed to improve bone cut accuracy
Devices
FDA has approved a CorMatrix Cardiovascular early feasibility study IDE to evaluate the safety and feasibility of the Cor Tricuspid ECM cardiac valve for adults with endocarditis and for pediatric patients with congenital heart valve disease. The device is described by the company as the first cardiac valve of its
Devices
FDA has cleared a Hologic de novo submission for the Aptima Mycoplasma genitalium Assay, a new test to aid in the diagnosis of the sexually-transmitted infection called Mycoplasma genitalium (M. gen.). This is the first test authorized by the agency to test for this bacterium, which is associated with
Devices
King & Spalding attorneys have posted a detailed review of three documents released by FDA 1/7 relating to the agency’s software precertification pilot program. The documents are: (1) the Developing a Software Precertification Program: A Working Model (Version 1.0); (2) the Software Precertification Program: 2019 Test Plan;
Devices
AdvaMed says it is proposing legislation to help “fix” some of the disruption FDA is experiencing in collecting user fees and reviewing medical device applications during this and any future government shutdowns. Under the proposal, the trade group says, FDA could continue to collect user fees and review applications that
Devices
Attorneys general in 46 states have reached a $120 million settlement with Johnson & Johnson and DePuy to resolve allegations that the medical device company unlawfully promoted two metal-on-metal hip implant devices—the ASR XL and the Pinnacle Ultamet. An announcement by New York State attorney general Letitia
Devices
FDA has cleared a Perspectum Diagnostics 510(k) for MRCP+ biliary visualization software. The artificial intelligence (AI) device is designed to enable quantitative and objective assessment of the bile ducts. The company says it uses quantitative MRI and AI algorithms for magnetic resonance cholangiopancreatography (MRCP) images “to provide improved visualization
Devices
FDA has cleared a Rebound Therapeutics 510(k) for the Aurora Surgiscope System, which the company describes as the world’s first single-use disposable neurosurgical endoscope for minimally invasive access, visualization and illumination of target neuro anatomy. The device comprises two components — a sterile, single use, neurological endoscope called
Devices
FDA has published a guidance, Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection, with recommendations to facilitate industry development and validation of assays for assessing the immunogenicity of therapeutic protein products during clinical trials. Specifically, the document includes guidance on the development and
Devices
The Duke-Margolis Center for Health Policy says artificial intelligence (AI) has been introduced into many areas of medicine, including clinical decision support (CDS) software. It has issued a report examining the benefits and challenges when AI has been incorporated into CDS software, particularly software that supports improved clinical diagnosis,