Devices
FDA has cleared an In2Bones Global 510(k) for the Quantum Total Ankle. The device treats patients who suffer from arthritis and is designed to improve patient mobility and increase stability, the company says. It features an anatomically designed talus with a dual radius of curvature to improve the dorsi
Devices
FDA has permitted the de novo marketing of Caption Health’s software to assist medical professionals in capturing cardiac ultrasound or echocardiography images. The software, called Caption Guidance, is considered an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence to help users capture images of a patient’s
Devices
GE Healthcare has recalled the Carestation 600 Series Anesthesia Systems because there is a potential for a loose cable connection inside the system which may cause the mechanical ventilation to stop operating. If this happens, the system will sound a high priority audio and visual alarm to alert health care
Devices
FDA has cleared a Life Spine 510(k) for its Steerable Plateau Ti Spinal System. The company says the device allows for controlled delivery to help positioning in the disc’s anterior space. It features a curved design to match patient anatomy and maximize endplate coverage, it says, adding that
Devices
Becton Dickinson (BD) says FDA this week told the company that modifications to the Alaris infusion pump will require a 510(k) filing, and it will sideline sales of the device through the remainder of this fiscal year. The device, which the company says is used on about 70% of
Devices
The Justice Department says former Walter Reed National Military Medical Center prosthetics and orthotics department chief David Laufer has been indicted by a federal grand jury on five counts of making false statements. The indictment alleges that he failed to report financial benefits he received from an unnamed individual and
Devices
FDA has again posted an online notice that Cardinal Health has alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource Procedure Packs containing those gowns. The notice says the company has sent urgent medical device recall letters for the devices to its
Devices
FDA has cleared a BioElectronics 510(k) for its over-the counter (OTC) ActiPatch medical device and its expanded indication — adjunctive treatment of musculoskeletal pain. The device was originally cleared in 2017 for OTC treatment of pain from knee osteoarthritis and plantar fasciitis. The device uses electromagnetic pulse therapy for
Devices
A 4/8-4/11/19 FDA inspection at Won Industry Co., Siheung-si, Republic of Korea, found Quality System Regulation violations in the firm’s manufacturing of the Morning Life Compression Limb Therapy System. The inspection was a follow-up to a 2015 inspection and found recurring violations. A
Devices
GE Healthcare has begun a Class 1 recall of its CareScape Respiratory Modules and Airway Gas Option due to a manufacturing issue which may cause the devices to display incorrect oxygen values. Incorrect oxygen values could lead to high (hyperoxia) or low (hypoxia) blood oxygen levels in patients, according to
Devices
FDA has approved a Conturais PMA for Bulkamid for treating stress urinary incontinence (SUI) due to intrinsic sphincter deficiency in adult women who have SUI or stress predominant mixed incontinence. The soft hydrogel comprises 2.5% polyacrylamide and 97.5% water, according to the company. Once injected, it says, (XXX
Devices
CDRH is using the 2019 ASCA Annual Report to detail progress made during the year toward an Accreditation Scheme for Conformity Assessment (ASCA) pilot program as required under the 2017 FDA Reauthorization Act. The report says the pilot “is anticipated to augment confidence in and reliance upon Declarations of Conformity
Drugs
ML Strategies senior director Aaron Josephson says changes are likely to be made in the medical product user fee programs that are starting the reauthorization process this year. In an online post, Josephson highlights some changes made to the programs when they were last reauthorized through the 2017 FDA Reauthorization
Devices
FDA has issued a coronavirus emergency use authorization to permit the wider use of a Centers for Disease Control and Prevention (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, the reverse transcriptase polymerase chain reaction test has been limited to use at CDC laboratories. Testing is limited
Devices
FDA has cleared a Qynapse 510(k) for its QyScore software that analyzes brain MRI markers that occur early in diseases such as Alzheimer’s disease, Parkinson’s disease and multiple sclerosis. The software is intended to generate a patient report that is compared to a healthy subjects database to
Devices
Boston Scientific has issued an urgent field safety notice about installing a firmware update for its Maestro 4000 Cardiac Ablation System. The update addresses the potential for “unintended continuation of radiofrequency (RF) energy delivery from the Maestro 4000 Cardiac Ablation System after releasing the foot switch,” the notice says. Only
Devices
FDA has cleared an Olympus 510(k) for the TJF-Q190V duodenoscope with a sterile, disposable distal endcap. The device is designed to improve its cleaning and reprocessing to reduce potential contamination, the company says, adding that it responds to the agency’s call for duodenoscopes with disposable components that
Devices
FDA says that Medtronic 1/30 has released the first round of software updates to address some cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between the company’s implantable cardiac devices, clinic programmers, and home monitors. Medtronic will issue additional rounds of software updates to address the
Devices
FDA has designated two Association for the Advancement of Medical Instrumentation standards as recognized consensus standards. By attaining FDA recognition, voluntary consensus standards can be used in premarket submissions to demonstrate conformity with relevant FDA regulations and requirements. The two are the newly updated ANSI/AAMI/ISO 14971:2019, a
Devices
FDA has cleared a BioIntelliSense 510(k) for the BioSticker on-body sensor for remote monitoring and care. It is a single-use device that provides continuous vital signs monitoring and actionable insights, the company says. Data are delivered to clinicians from patients in the home setting for early detection
Devices
The California Superior Court has ordered Johnson & Johnson to pay $343.99 million in penalties for false and deceptive marketing of its pelvic mesh products for women. The California Department of Justice sued the company 5/2016 after a years-long multistate investigation showed the company had neglected to
Devices
FDA has cleared a Sony Electronics 510(k) for its Nucleus Operating Room Imaging Management and Collaboration Control platform. The device supports 4K resolution using existing network infrastructures, and it provides operating rooms and clinical spaces with direct access to imaging data from a central dashboard, the company says. It