Devices
FDA has cleared a Tenon Medical 510(k) for an expanded indication for the Catamaran SI Joint Fusion System for use in augmenting thoracolumbar fusion. With the clearance, the Catamaran is now indicated for treating the SI (sacroiliac) joint as either a stand-alone treatment or to augment spinal fusion.
Devices
Bard Peripheral Vascular is updating the instructions for use (Class 1 recall) for its Rotarex Atherectomy Systems after receiving reports about problems occurring with the helix portion of the device because it rotates at a high rate of speed and may be at risk of fracture or breakage. “Use of
Devices
FDA has cleared a Vent Creativity 510(k) for its AI-driven software product, Hermes Knee, which uses “deep learning” to generate surgical plans for mechanical, kinematic, and anatomical alignment techniques for total and partial knee arthroplasty procedures. The device is built on the Minerva platform, which allows users to
FDA Policy/General
Former 15-year FDAer Henry Miller, now an American Council on Science and Health distinguished fellow, says uncertainty rules as FDA awaits the confirmation of commissioner-designate Martin Makary. Writing in his personal Pundicity online blog, Miller says that while specific priorities for Trump 2.0 are not yet clear,
Devices
An FDA medical device early alert says the agency is aware that Calyxo has notified affected customers that its CVAC Aspiration Systems have updated instructions for use. The alert says Calyxo identified a new risk of injury during use of the system when patients have high viscosity fluid in the
Devices
FDA says the Baxter 2/5 recall of certain Spectrum infusion pumps is Class 1. An updated medical device early alert says the pumps were recalled due to the potential for missing motor mounting screws, which may have occurred during the servicing process. The company said the affected pumps should
Devices
IceCure Medical says FDA has delayed its review decision on the company’s de novo marketing authorization request for ProSense and its use in early-stage low-risk breast cancer with endocrine therapy. The decision was expected this quarter and now the company says it should be issued next quarter,
Devices
Becton, Dickinson is correcting software (Class 1 recall) for the BD Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter after receiving reports that customers running both may experience delayed system response and backlogging of automated programming requests (APRs). “After the delay, outdated APRs may upload to the Alaris
Devices
Smiths Medical has recalled (Class 1) its ProPort Plastic Venous Access System because the device’s plastic port housing and port reservoir may separate due to a manufacturing defect. According to a recall notice. FDA has determined that the defect is related to the firm’s process controls. Last month,
Devices
FDA has cleared a bioMérieux 510(k) for the latest version of its Vitek Compact Pro for microorganism identification (ID) and antibiotic susceptibility testing (AST) to help diagnose infectious diseases and combat antimicrobial resistance. The device is designed to provide efficient workflows, and fast routine ID/AST results and microbiology
Devices
FDA has cleared a Moon Surgical 510(k) for its ScoPilot, an artificial intelligence-powered feature on the company’s Maestro System that is intended to ensure a stable and ideal view during laparoscopic surgery. “On-demand and easy to use, ScoPilot allows the laparoscope attached to a Maestro System
Devices
Medtronic Neurovascular is recalling its Compatible Pipeline Vantage Embolization (027) Devices and updating the use instructions for their 021 version due to reports about the flexible, braided tube part of the device failing to properly attach or stay attached to blood vessel walls (incomplete wall apposition or braid deformation) during
Devices
Three former executives of Magellan Diagnostics have pleaded guilty to federal charges after concealing a medical device malfunction that led to inaccurately low lead test results for thousands of children and other patients. Former CEO Amy Winslow, former chief operating officer Hossein Maleknia, and former quality assurance and regulatory affairs
Devices
FDA is warning healthcare professionals about supply interruptions involving hemodialysis bloodlines because of recent supplier issues. “The disruption in supply of this device is expected to impact patient care and as such may require adjustments to the clinical management of patients receiving acute or chronic hemodialysis,” an agency notice says.
Devices
Becton Dickinson’s CareFusion unit has recalled (Class 1) its BD Alaris Systems Manager, including the device’s infusion safety management software, due to software issues that could provide incorrect therapy. The software issue may result in an outdated automated programming request being sent to the device’s progressive care
Devices
FDA has approved a Valcare Medical IDE to assess the safety and functionality of its AMEND Trans-Septal System for treating patients with mitral insufficiency. The company says the device is designed for transcatheter mitral annuloplasty and “features a semi-rigid, closed, D-shaped annuloplasty ring that replicates the current
Devices
Smiths Medical has recalled its Portex Endotracheal Tube because some devices have a smaller diameter than expected and may result in inadequate ventilation to patients. According to a recall notice, patients may experience hypoxia, underdose, or cardiopulmonary collapse if an affected device is used. FDA has identified the issue as
Devices
A 7/29-8/8/2024 FDA inspection at Q’Apel Medical in Fremont, CA, determined that the firm manufactures the Hippo 072 aspiration system that is adulterated because Q’Apel does not have an approved PMA application or IDE for it. A 2/5 Warning Letter says the system
Devices
Nearly one-third of medical device adverse event reports submitted to FDA’s Manufacturer and User Facility Device Experience (MAUDE) database arrived later than the 30 days allowed by agency regulations, according to an analysis by researchers from several academic medical centers. “Late reporting to the MAUDE database could preclude
Devices
FDA has cleared a Canon Medical 510(k) for artificial intelligence (AI) enhancements for the Aquilion One/Insight Edition CT scanner. The modifications include the company’s new Precise IQ Engine (PIQE), which uses “deep learning reconstruction” technology to maximize the scanner's resolution, the company says. “This technology
Devices
Akin Gump attorneys Nathan Brown and Maddy Bolger say FDA has created a Web page on medical device data integrity that apparently will include CDRH letters to testing laboratories discussing their data integrity issues, helping companies to know which laboratories may have data integrity issues. The new Notifications on Data
Devices
The Doctor Patient Forum (DPF), which says it is a nonprofit organization advocating for chronic pain patients and healthcare providers, is petitioning FDA to classify and regulate Bamboo Health’s NarxCare platform as software as a medical device. The petition describes NarxCare as a proprietary risk-scoring algorithm used in