Devices
FDA says Oscor has expanded its 9/29 recall for certain lots of TB Unshrouded Bipolar Pacing Leads to include expired inventory for devices distributed between 12/21/11 and 5/17/18. A company recall notice posted by FDA says the expansion is to ensure proper disposition of expired
Devices
FDA says the GE Healthcare Millennium Nuclear Medicine Systems recall is Class 1. GE says the devices are used to take images of a patient’s organs or tissues to help diagnose or treat a health condition or disease. The systems are intended for use as diagnostic imaging devices that
Devices
FDA has cleared a Canon Medical Systems 510(k) for its new premium MRI system, Vantage Orian 1.5T. The device features Rapid Scan technologies to reduce scan time, a dockable table to assist in seamless patient handling, and low energy consumption to minimize running costs, the company says. It
Devices
FDA has released three documents produced by the International Medical Device Regulators Forum, of which the agency is a member. Optimizing Standards for Regulatory Use says that standards play a significant role in the design, production, post-production, and regulation of medical devices throughout their lifecycle. “Standards offer a means
Devices
FDA says it has received numerous Medical Device Reports on adverse events with implanted pumps that may be used for intrathecal administration of pain medicines not approved by the agency for use with the specific implanted pump. An agency safety communication says that while some individual patients may experience relief
Devices
FDA has cleared a Lumendi 510(k) for its DiLumen EIP technology with “suture loops” placed in the skirt along the trailing edge of the fore balloon, a modification to improve tissue retraction during therapeutic endoscopy. “This new device feature will help facilitate tissue manipulation for easier dissection and resection
Devices
A 3/26-3/30 FDA inspection at US Vascular, LLC, Beaverton, OR, found Quality System and Medical Device Reporting violations in the firm’s manufacturing of Class 2 VascuLab devices used in vascular pathology. A just-released 6/7 Warning Letter says violations were: * failing to establish procedures for
Drugs
The Stericycle Recall Index for the third quarter of 2018 shows that drug recalls increased 19% to 92, although recalled units declined 56% to just over seven million, lower than in 10 of the last 13 quarters. The report says that failed specifications were the top reason based on recalls
Devices
CDRH biomedical engineer Ifeanyi Uwemedimo told a CDRH Webinar that comments received on a 2014 draft guidance on benefit risk factors to consider when determining substantial equivalence (SE) in premarket notifications with different technological characteristics fell into three broad groupings. In finalizing the guidance that was issued 9/25, FDA
Devices
Sen. Judiciary Committee chairman Chuck Grassley (R-IA) has stepped up pressure on FDA after a recent HHS Inspector General (OIG) report said FDA should take steps to have its policies and procedures better address medical device postmarket cybersecurity risks. OIG found that FDA’s policies and procedures were insufficient
Devices
FDA has issued Chembio Diagnostic Systems an emergency use authorization for its DPP Ebola Antigen System, a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). The fingerstick test uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in
Drugs
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says FDA regulation of some medical devices as drugs violates the distinction Congress has drawn between the two regulatory schemes. “FDA’s position that it may regulate devices as drugs is plainly not authorized under the Federal Food, Drug, and Cosmetic Act (FFDCA)
Devices
FDA says it has cleared a new Monteris Medical NeuroBlate probe containing a non-metallic fiber optic temperature sensor to address unintended probe heating in the magnetic resonance environment. The new probe replaces the metallic thermocouple temperature sensor of the original probe that was the subject of an agency 3/
Devices
The National Cybersecurity and Communications Integration Center says several Roche handheld medical devices have cybersecurity risks that could be exploited with adjacent access and a low skill level. The notice says the vulnerabilities include improper authentication, OS command injection, unrestricted upload of file with dangerous type, and improper access control.
Devices
FDA has cleared a MaxQ AI 510(k) for its Accipio Ix intracranial hemorrhage detection software. The company says the artificial intelligence software is designed to aid in prioritizing the clinical assessment of adult non-contrast head computed tomography (CT) cases that exhibit indications of intracranial hemorrhage (brain bleed). “Accipio
Devices
FDA has cleared an MRI Interventions 510(k) for its latest software platform, ClearPoint 2.0. The platform’s new features are designed to improve the clinical workflow and user experience of the company’s ClearPoint Neuro Navigation System, including “enhanced functionality in areas of image fusion, volume of interest
Devices
A 10/25 CDRH Webinar explained a recent guidance on appropriate use of voluntary consensus standards in premarket submissions for medical devices. During the program, CDRH director of the standards and conformity assessment program Scott Colburn reviewed the evolution of the guidance from its 2014 draft to changes that were
Devices
FDA has cleared a NinePoint Medical 510(k) to market its Intelligent Real-time Image Segmentation software upgrade for its NvisionVLE Imaging System. The artificial intelligence-based platform for image feature segmentation is intended for use in imaging esophageal tissue. The imaging system allows physicians to perform a volumetric laser
Devices
FDA has cleared a Shoulder Innovations 510(k) for the InSet Humeral Short Stem System for partial or total shoulder arthroplasty used in the treatment of degenerative, rheumatoid or traumatic arthritis in the shoulder. The system includes streamlined instrumentation and proprietary coating technology for implant fixation with bone preservation, the
Devices
FDA has classified as Class 1 a Roche Diagnostics recall of its CoaguChek XS PT Test Strips due to inaccurate International Normalized Ratio (INR) test results, when compared to laboratory results. Roche re-calibrated the strips in January to correspond to a newly released INR International Standard. Since the re-
Devices
FDA has posted a guidance on “Unique Device Identification (UDI): Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking.” UDI system requirements are being phased in over seven years according to established compliance dates based primarily on device classification. The guidance outlines FDA’
Devices
FDA has permitted the de novo marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands). The clearances were issued to Fluoptics for