Devices
Boston Scientific has received IDE approval to begin enrolling in the HI-PEITHO clinical trial to compare its EkoSonic Endovascular System (EKOS) in combination with anticoagulation therapy to anticoagulation alone for treating acute, intermediate-high-risk pulmonary embolism (PE). The collaborative research study is being conducted by the Pulmonary Embolism
Devices
In a detailed report, the investigative newsroom Pro Publica says FDA relies too much on medical device manufacturers to correct problems with their products and takes too little action to ensure compliance. The report focuses primarily on the HeartWare ventricular assist device (HVAD) used as a heart pump while a
Devices
FDA has approved a Pillar Biosciences PMA for its oncoReveal Dx Lung and Colon Cancer Assay, a next-generation sequencing (NGS) tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal cancer tumors. Pillar says the
Devices
FDA says an Eight Medical 2/5/21 recall of specific lots of its Recirculator 8.0 disposable lavage kit was Class 1. The company recalled 288 devices in the U.S. An FDA recall notice says the kit is used with the company’s hyperthermic perfusion system. It allows
Devices
Eco-Med Pharmaceuticals has recalled certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination. Affected products are also distributed as MediChoice Ultrasound Gel by Owens and Minor and Mac Medical Supply. The gels are non-sterile and not indicated for sterile procedures, the company says. The
Devices
FDA has cleared a Camber Spine 510(k) for both its Spira-P Posterior Lumbar Spacer technology and Spira-T Oblique Posterior Lumbar Spacer technologies. The clearance covers their use in skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2-S1.The devices are
Devices
BD says it will begin remediation for the 2/4/20 BD Alaris system 1 recall through a new version of software. The recall notified customers of several conditions under which the Alaris infusion pump may not operate as expected. BD says the new software is expected to remediate the
Devices
FDA says it is participating in several new collaborative communities intended to address challenges in patient health care. An online notice says the communities are a continuing forum where private and public sector representatives of the community work together on medical device challenges to achieve common objectives and outcomes. The
Devices
FDA has posted a Web page that responds to common questions on online 506J notification submission methods concerning medical device manufacturing interruptions, including the Web form and spreadsheet template. The page covers submissions under section 506J of the Federal Food, Drug, and Cosmetic Act during the Covid-19 pandemic. The
Devices
Arriva Medical, at one time the nation’s largest mail-order diabetic testing supplier, and its Alere parent will pay $160 million to resolve allegations they violated the False Claims Act. A Justice Department news release says Arriva ceased business operations 12/2017. It was acquired by Alere in 2011.
Devices
Philips Respironics has recalled its V60 and V60 Plus ventilators that provide High Flow Therapy (software version 3.00 and software version 3.10), due to a risk to the patients if the system pressure reaches the default maximum limit. “This can occur if the oxygen flow is partially blocked
Devices
FDA has cleared an Abbott 510(k) for its latest optical coherence tomography (OCT) imaging platform powered by the company’s new Ultreon Software. The software combines OCT with artificial intelligence (AI) to provide physicians a better view of coronary blood flow and blockages to assist physician decision-making and
Devices
FDA has cleared a RealView Imaging 510(k) for its Holoscope-i holographic system for creating spatially accurate, three-dimensional interactive medical holograms based on data received from standard CT scans and 3D ultrasound systems. The device features an over-the-head system configuration suspended above the physician, without the
Devices
FDA has granted Biofourmis a breakthrough device designation for BiovitalsHF, a software medical application that is intended to augment guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy. It specifically is designed to assist with guideline-directed medical therapy in patients with heart failure
Devices
FDA has dismissed concerns raised in a JAMA Internal Medicine report (see earlier story) that many medical device adverse event reports (MDRs) involving a patient death are classified in categories other than death in the agency’s Manufacturer and User Facility Device Experience (MAUDE) database. An FDA spokeswoman told FDA
Devices
FDA has cleared a TransMedics Group 510(k) for its OCS Lung Solution for use in transplants using cold storage techniques. The device is indicated for hypothermic flushing, storage and transportation of donor lungs for transplantation, according to the company. It is a colorless, sterile, pyrogen-free, colloid-based extracellular
Devices
Washington Legal Foundation (WLF) is asking the 1st Circuit Court of Appeals to reverse on First Amendment grounds the criminal convictions of two former medical device company executives under the Federal Food, Drug, and Cosmetic Act (FFDCA). WLF submitted an amicus brief on behalf of the two Acclarent former executives
Devices
FDA has cleared a Volpara Health 510(k) for the latest version of its key science algorithm, Volpara Imaging Software (VIS 3.2), a breast density assessment algorithm that incorporates learnings from artificial intelligence. The company says the clearance also expands the software’s use on additional mammography machines, increasing
Devices
Researchers at the University of California San Francisco and other locations say that many medical device adverse event reports that involve a patient death are classified in categories other than death in the FDA Manufacturer and User Facility Device Experience (MAUDE) database. “As FDA only routinely reviews all adverse events
Devices
FDA has cleared two Medtronic AccuRhytm AI algorithms for use with the LINQ II insertable cardiac monitor. The company says the AccuRhythm AI applies artificial intelligence (AI) to heart rhythm event data collected by LINQ II, improving the accuracy of information doctors receive so they can better diagnose and treat
Devices
FDA has cleared an Asensus Surgical 510(k) for its 5 mm diameter articulating instruments for use on the Senhance Surgical System technology platform. Articulating instruments offer better access to difficult-to-reach areas, according to the company. The surgical system is a digital laparoscopic platform that leverages machine learning.
Devices
FDA has approved a Synchron IDE application for its Stentrode motor neuroprosthesis. The company says an early feasibility study of the device will begin later this year at Mount Sinai Hospital in New York to assess device safety and efficacy in patients with severe paralysis. Outcomes will include the use