Devices
FDA has cleared a Tempus AI 510(k) for its Tempus ECG-AF device that uses artificial intelligence to help identify patients at increased risk of atrial fibrillation/flutter (AF). The company says this is the first FDA clearance for an AF indication in the category known as “cardiovascular machine
Devices
FDA has cleared a Fujifilm Healthcare Americas 510(k) for its new compact, 128-slice computed tomography (CT) system, the FCT iStream. The device consolidates four core proprietary Fujifilm technologies, including HiMAR Plus (High image quality Metal Artifact Reduction), Intelli IPV, SynergyDrive and IntelliODM to “enhance the sharpness of images,
Devices
Advanced Medical Technology Association (AdvaMed) says there are inconsistencies and ongoing concerns with FDA’s guidance entitled “Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff.” In comments submitted about the final guidance, AdvaMed contends that when an earlier draft
Devices
FDA has approved an Endotronix PMA for its Cordella Pulmonary Artery (PA) Sensor System for treating New York Heart Failure Class III heart failure patients. The device is the “only PA pressure-guided platform to offer comprehensive patient management using daily PA pressure and vital signs from home to guide
Devices
Zoll Medical has recalled (Class 1) its Zoll 731 Ventilators (EMV+, AEV, Eagle II MRI compatible devices) and their operator and quick reference guides. A recall notice says the guides omit patient safety ventilator MRI information, and they are being updated with instructions to ensure safe distance from the MRI
Drugs
FDA has published a guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection, meeting a requirement for such a guidance in the 2012 FDA Safety and Innovation Act. The document finalizes a 12/16/2022 draft guidance and supersedes a 10/2014 guidance, which is
Devices
FDA has granted Onkos Surgical a de novo authorization for its novel antibacterial coating for use with implants. “Implant contamination is a growing concern to the orthopedic surgical community,” the company says. The coating technology was authorized based on data showing that the “proprietary coating does not elute and has
Drugs
FDA has published a report on the topics discussed at an 11/29-30/2023 public workshop it held with the Clinical Trials Transformation Initiative to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the
Devices
Stimwave founder and former CEO Laura Perryman has been sentenced to six years in prison by a New York federal judge in connection with a healthcare fraud scheme in which she created and sold a fake medical device component and told doctors they could claim $16,000 to $18,000
Devices
FDA is asking for input on certain non-device software functions and their impacts on patient safety. A Digital Health Reports online notice says the agency is requesting input on patient safety, including best practices to promote patient safety, education, and competence, associated with medical software functions that are excluded
Devices
FDA has granted Elixir Medical a Breakthrough Device Designation for its novel bioadaptive implant DynamX Sirolimus-Eluting Coronary Bioadaptor System for improving coronary luminal diameter, restoring hemodynamic modulation, and reducing plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The device
Devices
FDA has cleared an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder (ADHD). Delivered through a video game experience, EndeavorOTC is intended to improve attention function as measured by computer-based testing in men and women with primarily
Devices
Developing a medical device “quality assurance practice” for artificial intelligence (AI) models should be a priority to ensure clinical outcomes are optimal with the use of AI models that are “accurate, reliable, ethical, and equitable,” a new online agency post says. “Top of mind for device safety is quality assurance
Devices
Teleflex and subsidiary Arrow International are recalling (Class 1) the Arrow FiberOptix Intra-Aortic Balloon Catheter Kits and Arrow UltraFlex Intra-Aortic Balloon Catheter Kits after determining that a manufacturing error may cause the device’s balloon to become overtwisted. “This issue may prevent the balloon from fully inflating, cause
Devices
Getinge is recalling (Class 1) its Vaporizer Sevoflurane Maquet Filling after receiving reports of discoloration or corrosion within the vaporizer after the device was used with low water content sevoflurane manufactured by Piramal or Baxter. Sevoflurane used in the vaporizer may degrade to hydrogen fluoride, a recall notice says, adding
Devices
Megadyne is recalling (Class 1 — market withdrawal) its Megadyne Mega Soft Pediatric Patient Return Electrodes after receiving reports about patients being burned in procedures using the devices. “The use of affected product may cause serious adverse health consequences for pediatric patients, including third-degree burns, scarring, and additional surgeries,” a
Devices
FDA has cleared an Avicenna.AI 510(k) for its CINA-VCF, a triage and notification artificial intelligence tool for detecting unsuspected vertebral compression fractures (VCFs) in patients undergoing chest or abdomen CT scans. “Often resulting from the deterioration of bone structure (osteoporosis), VCFs can cause significant pain, deformity, and
Devices
FDA has cleared a Getinge 510(k) for its innovative clinical decision support software Talis +ACG (Advanced Clinical Guidance), which the company says is intended for use to help promote compliance with care protocols directly at the bedside in high acuity care environments. The clearance covers the company’s Talis-
Devices
FDA has cleared a Spinal Simplicity 510(k) for its Wolff’s Law Anterior Cervical Plate System. The device features “active compression,” which provides continuous 24/7 compression to assist in achieving spinal fusion, according to the company. It also features a low-profile plate to minimize tissue disruption, and
Devices
Insulet is recalling (Class 1) its Omnipod DASH Insulin Management System’s Personal Diabetes Manager after receiving reports of battery issues (e.g., swelling, fluid leakage and overheating). A recall notice warns that users could be exposed to battery fluid and extreme heat, and there is a risk for an
Devices
FDA has published the three 2024 enhancements to CDRH’s electronic medical device reporting (eMDR) system. The page says the FDA eSubmitter client is updated concurrently with the eMDR system, but industry with system-to-system, or AS2, accounts with the FDA electronic submissions gateway should use the enhancement information
Devices
Medline Industries is recalling (Class 1) its Sub-G Endotracheal Tube with Subglottic Suction due to detachment or tearing of the inflation tube and other device components from the main tube. A recall notice says the device malfunctions could result in cuff leakage, deflation, moisture buildup, and failure to inflate.