Devices
FDA has issued an early alert highlighting serious safety concerns with Baxter's Novum IQ large volume infusion pump, following reports of underinfusion, overinfusion, and two patient deaths. According to Baxter, the device may deliver insufficient medication or fluids when transitioning from a lower to a significantly higher flow
Biologics
An 8/23-8/31/2023 FDA inspection at the O3UV facility in Grand Ledge, MI, documented multiple violations in the firm’s illegal manufacturing of autohemotherapy devices. A 7/7 Warning Letter says the firm’s products are adulterated because the company does not have an approved PMA or
Devices
Maquet Critical Care AB, a subsidiary of Getinge, is recalling (Class 1 device correction) its Servo Ventilator Systems to update their use instructions due to the risk of inaccurate compliance measurement leading to improper tidal volume delivery in neonatal patients. The devices can be used with several different patient circuits
Devices
Integra LifeSciences is recalling (Class 1) its MicroMyst Applicators due to incomplete bioburden assessments and incomplete sterilization location transfer documentation, both of which help ensure the products were adequately sterilized. “The use of affected product may cause serious adverse health consequences, including inflammation, infection, and death,” a recall notice says.
Devices
SunMed Holdings is recalling (Class 1) its Adult Manual Resuscitator devices due to incorrect assembly of the bacterial/viral filter. “The use of affected product may cause serious adverse health consequences, including lack of oxygen to the body (hypoxia), build-up of carbon dioxide in the blood (hypercapnia), organ failure,
FDA Policy/General
While FDA updates and improves its Elsa internal generative artificial intelligence (AI) tool, questions and concerns persist in the industry that FDA is potentially using a tool that might not have passed the agency’s own expectations for the validation, governance and transparency of such tools when used for FDA-
Devices
FDA says Whoop, Inc., Boston, MA, is marketing its Blood Pressure Insights (BPI) medical device without agency approval and despite agency assertions that Blood Pressure Insights is legally considered to be a medical device that requires premarket approval. A 7/14 Warning Letter says the firm’s Web site indicates
Devices
FDA has cleared a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operative guidance for transcatheter heart valve implantation. The device is intended to enhance implant procedure precision and improve patient outcomes, according to the company, adding that the
Devices
BD and subsidiary CareFusion have issued an “Urgent Medical Device Recall (Correction)” letter about performance issues, under certain use cases, for the BD Alaris Pump Module model 8100 when used with a subset of compatible pump infusion sets. “BD stated that they have identified a subset of compatible pump infusion
Devices
FDA has granted Artera a breakthrough device designation for its ArteraAI Prostate, an artificial intelligence-based tool designed to assist clinicians in personalizing treatment decisions for patients with localized prostate cancer. The company says the device’s software uses multimodal artificial intelligence to analyze digital pathology images from a patient’
Devices
AirLife is recalling certain lots of its Broselow Pediatric Emergency Rainbow Tape because they were manufactured with incorrect information on the tape. “Incorrect joules in the cardioversion and defibrillation section are printed in the red zone of the tape,” a recall notice says. “Using the incorrect information in this section
Devices
A University of Illinois law school scholar who specializes in the ethical and legal challenges of artificial intelligence (AI) for health care says FDA needs to develop labeling standards for AI-powered medical devices. A university news release says Sara Gerke suggests that the labeling follow the format of mandatory
Devices
The Foundation for Defense of Democracies (FDD) says that medical devices such as pacemakers, insulin pumps, and vital signs monitors that are already in use in healthcare settings are vulnerable to hacking despite a new FDA guidance. An FDD paper says the guidance doesn’t have a requirement that companies
Devices
FDA has cleared an Exactech 510(k) for the Equinoxe Scapula Reconstruction System for treating acromial and scapular spine fractures. The device allows orthopedic surgeons to treat scapular fractures using several different techniques, including single and dual plating, regardless of placement of any particular reverse total shoulder arthroplasty implant design.
Devices
AirLife and Vyaire are recalling (Class 1) certain infant heated wire circuits due to the risk that accessory adapters may unintentionally disconnect during setup or use when the circuit reaches operating temperature. “Use of the affected product may cause serious adverse health consequences, including lack of oxygen to the body
Devices
A 1/21-1/27 FDA inspection at Insightra Medical Inc. in Clarksville, TN, found multiple violations in the firm’s manufacture of the Double Pump and the Ultra Intra Aortic Balloon Pump (IABP) catheter kits. A just-released 6/3 Warning Letter says the IABP catheter kit is adulterated
Devices
FDA has approved an expanded indication for Insightec’s Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients living with advanced Parkinson's disease (PD). The device previously received approval for unilateral treatment of medication-refractory essential tremor in 2016, tremor-dominant PD in 2018, and unilateral
Devices
An FDA Early Alert says the agency is aware that Abiomed has issued a letter to affected customers recommending that all Automated Impella Controllers have updated instructions for use. The alert says users should be aware that the controller may not detect an Impella pump when connected. It says they
Devices
FDA has given 510(k) clearance to Philips’ SmartSpeed Precise dual AI (artificial intelligence) software across the company’s entire portfolio of MRI systems. A company statement says SmartSpeed Precise combines: * compressed SENSE, Philips’ acceleration engine; * an AI-powered denoising engine that enhances image clarity by reducing noise; and * a
Devices
In an updated safety communication, FDA says Contec has issued a software patch to fix cybersecurity vulnerabilities in certain Contec and Epsimed patient monitors. The agency notice says the patch fully removes networking functionality from the affected monitors, making them usable only for local monitoring. In a 1/30 safety
Devices
FDA says Baxter has issued a letter to affected customers recommending that certain Spectrum infusion pumps be removed from where they are used or sold. An agency Early Alert said Baxter recommended that customers with the affected pumps remove them from service and check the software version installed on the
Devices
FDA has approved a Sirtex Medical PMA for its SIR-Spheres Y-90 resin microspheres for treating unresectable hepatocellular carcinoma (HCC) in the United States. HCC is the most common form of liver cancer in adults in the U.S., according to the American Cancer Society. Radioembolization with SIR-Spheres