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
Devices
FDA has cleared an Atmo Biosciences 510(k) for the ingestible Atmo Gas Capsule System for assessing both whole and regional gut transit times — covering the stomach, small bowel, and colon — as an aid in diagnosing gastrointestinal motility disorders (gastroparesis and slow transit constipation). “By measuring regional and whole gut
Devices
FDA has posted a draft guidance entitled “Unique Device Identifier (UDI) Requirements for Combination Products.” The document discusses how the agency’s UDI requirements apply to combination products with device constituent parts. It also outlines requirements, recommendations, and best practices for UDI labeling and submission of information to the Global
Drugs
FDA has published a guidance, Conducting Remote Regulatory Assessments—Questions and Answers, to help enhance the industry’s understanding of such assessments, thus facilitating the process for FDA conducting the assessments. The document says the term Remote Regulatory Assessment (RRA) is used to describe a category of activities for which
Devices
FDA has released a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The document applies to devices with cybersecurity considerations, including but not limited to those that have a device software function or that contain software (including firmware) or programmable logic, and it
Devices
FDA has approved an InspireMD PMA for its CGuard Prime Carotid Stent System for treating carotid artery stenosis. The device is described as a novel mesh-covered stent designed to improve patient safety through sustained embolic protection. The device’s approval is supported by data from the company’s C-
Devices
Cook Medical has recalled (Class 1) its Beacon Tip 5.0 Fr Angiographic Catheter because it may experience tip separation. The issue was identified through field complaints, with users reporting tip separation occurring both prior to and during patient contact, a recall notice says. “If an affected product is used,
Devices
FDA has alerted healthcare providers to agency import alerts for certain medical devices manufactured by Olympus Medical Systems and its subsidiaries. An online notice says the alerts apply to specific models of the firm’s uteroenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors. “Despite extensive and ongoing efforts to address compliance
Devices
FDA has issued a safety alert on Medtronic subsidiary Given Imaging and certain Bravo CF Capsule delivery devices, which are designed to place and attach a pH monitoring capsule to the esophagus to assist a physician in diagnosing clinical gastroesophageal reflux. The alert says Medtronic has told customers that the
Devices
A 1/20-1/23 FDA inspection at Aju Pharm Co. Ltd. in Seongnam-Si, Gyeonggi, South Korea, found Quality System (QS) and Medical Device Reporting (MDR) violations in the company’s manufacturing of the Class 2 Fixone Hybrid Knotless Anchor and the Class 2 Fixone Biocomposite Anchor. A just-
Devices
GE HealthCare is recalling (Class 1 device correction) certain Carestation anesthesia devices due to the risk that they may not provide effective ventilation when used in volume control ventilation mode. “If this issue occurs, it will be apparent to the user through observation and multiple alarms,” a recall notice says.
Devices
FDA has cleared a DeepEcho 510(k) for its artificial intelligence (AI)-based fetal ultrasound analysis platform. The device “leverages advanced deep learning algorithms to automate real-time identification of fetal ultrasound views, providing healthcare professionals with enhanced diagnostic accuracy and efficiency,” the company says. The device’s technology is
Devices
The issuance by FDA of two Warning Letters to manufacturers of diagnostic products labeled for research use only (RUO) within three months may be a coincidence or may signal a new FDA enforcement emphasis. That’s the view of attorneys Dominick DiSabatino and Audrey Mercer (SheppardMullin) in their firm’s
Devices
A 10/29-12/20/2024 inspection at Reset Technology Corp. in Irving, TX, identified multiple violations in the firm’s manufacturing of the ResetSmile partial denture device and ResetSmile impression kit device. A 6/9 Warning Letter says specific Quality System Regulation violations were: * failure to ensure that when