Devices
FDA says Trividia Health has recalled one lot of 601 True Metrix self-monitoring blood glucose meters co-branded under the Good Neighbor Pharmacy brand and distributed in the U.S. A company statement posted by the agency says the recalled units may have the potential for defective LCD displays
Devices
FDA has given Nobles Medical Technology II the green light to restart its pivotal clinical trial evaluating the NobleStitch EL system, a device-free, suture-mediated method for closing a patent foramen ovale (PFO) to reduce recurrent cryptogenic stroke. The trial was paused in 2023 over a protocol update to
Drugs
In a Food & Drug Law Institute review of Warning Letters (WLs) issued by FDA since 1/9/2020, a Hyman, Phelps & McNamara attorney and a regulatory expert say Tuesdays are the most common day for a WL to appear on the FDA Web site. The analysis found that
Devices
A 4/9-4/21/2025 FDA inspection at Technological Medical Advancements in West Palm Beach, FL, identified multiple violations in the firm’s manufacturing of two unapproved laser systems. A 9/26 Warning Letter says specific Quality System Regulation violations were: * failure to adequately establish procedures to ensure that
Devices
FDA has granted IceCure Medical’s de novo marketing authorization for the ProSense cryoablation system for treating early-stage, low-risk breast cancer in women aged 70 years and older who are also receiving adjuvant endocrine therapy. The company says ProSense offers a minimally invasive, outpatient alternative to lumpectomy, using
Devices
A CDRH Learn education module presented by Postmarket Industry Education Team assistant director Tonya Wilbon covers the Quality Management System Regulation (QMSR) with its requirements for risk management, a risk-based approach, and risk-based decisions. The module defines essential risk terms; explains the role of risk management within the
Devices
CDRH has published a list of 11 guidances it expects to issue in FY 2026. The list contains an A-List (priority to publish) with four final guidances and four draft guidances. A B-List (publish as resources permit) has three final guidances and no drafts. For the first time,
Devices
FDA has cleared a UroViu 510(k) for its UV5000 cordless, single-use endoscope platform. The new device, which replaces the UV4500 currently on the market, is designed to improve clinical efficiency with a faster processor, longer battery life, and brighter high-definition visualization, according to the company. UroViu says
Devices
FDA has approved a Zoll Medical PMA for Zenix, the company’s newest monitor/defibrillator, which it says is designed to streamline emergency and hospital care. The device features a large touchscreen and customizable settings that allow healthcare professionals to adjust functions in real time. Among its key features are
Devices
FDA has issued an updated alert about an ongoing Class 1 recall of certain BD Alaris Pump Module infusion sets, warning that continued use of the affected devices could cause serious injury or death. The recall involves performance issues with the BD Alaris Pump Module model 8100 when used with
Devices
FDA has expanded its medical device “Early Alert” program to cover all products that may pose significant safety risks. CDRH launched the pilot program 11/2024 and it applied to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology device issues. It was designed to reduce the lag between when
Devices
FDA has granted Essilor a de novo marketing authorization for its Stellest eyeglass lenses, which are designed to both correct vision and slow the progression of pediatric myopia (nearsightedness). The lenses are indicated for children aged 6 to 12 years at the start of treatment, with or without astigmatism. “Today’
Drugs
FDA has published its Electronic Submission Gateway NextGen Unified Submission Portal Guide for Industry Users, outlining the functionalities, processes, and requirements for submitting regulatory information through the NextGen Unified Submission Portal (USP). The document says it is intended to facilitate a smooth transition to Electronic Submission Gateway NextGen, providing users
Devices
FDA has granted Biolinq a de novo authorization for its Shine system, the first fully autonomous, needle-free glucose sensor in the U.S, according to the company. The device features an integrated display and does not require a smartphone to deliver glucose readings. Unlike traditional continuous glucose monitors that
Devices
FDA has published a guidance, Computer Software Assurance for Production and Quality System Software, with recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. The document says it describes: * computer software assurance as a risk-based
Devices
Olympus has recalled (Class 1) its ViziShot 2 FLEX (19G) EBUS-TBNA needles manufactured prior to 5/12 after receiving reports of device components detaching during procedures. The ViziShot 2 FLEX is protected by a hypotube and sheath, a recall notice says, adding that the “hypotube protects the sheath from
Devices
FDA has issued an early alert after becoming aware that Abiomed had issued a letter to affected customers recommending certain Automated Impella Controllers be removed from where they are used or sold. “Abiomed identified Automated Impella Controller purge pressure issues due to purge retainer failures, such as cracks,” the alert
Devices
FDA has released a final guidance outlining how the agency will decide when to temporarily allow use of unapproved diagnostic tests during a declared public health emergency. The guidance, Consideration of Enforcement Policies for In Vitro Diagnostic (IVD) Tests During a Section 564 Declared Emergency, explains the factors FDA will
Devices
FDA has approved Medtronic’s Altaviva implantable tibial neuromodulation device, described by the company as a minimally invasive therapy for treating urge urinary incontinence. The device, inserted near the ankle, works by sending mild electrical impulses to the tibial nerve to help restore communication between the bladder and brain, according
Devices
FDA appears to be escalating medical device oversight this year, issuing more Warning Letters and relying on artificial intelligence to zero-in on compliance gaps, according to a new analysis from law firm Hogan Lovells. As of early September, the agency had issued 19 Warning Letters citing Quality System Regulation
Devices
FDA has issued a final rule rolling back a 2024 regulation that expanded the agency’s authority over laboratory-developed tests (LDTs), following a federal court decision that struck down the earlier policy. The move restores the regulatory definition of “in vitro diagnostic products” to its pre-2024 language, removing
Devices
FDA is issuing an alert after becoming aware that Abbott issued a letter to customers recommending updated instructions when removing the TactiFlex Ablation Catheter from its packaging. “Abbott has become aware of tip detachment events during catheter removal from the packaging,” the alert says. “Improper removal from the packaging can