Devices
A 7/10-7/11 FDA inspection at Dongguan Rainbow Tech Electronic & Plastic Products Co., Ltd., in Guangdong Sheng, China, found Quality System Regulation violations in the firm’s manufacturing of Class 2 manual emergency ventilators. A 10/7 Warning Letter says the specific violations were: * failure to establish
Devices
A 4/7-4/9 FDA inspection at Levo AG in Wohlen, Switzerland, found multiple violations in the firm’s manufacturing of several models of Class 2 stand-up wheelchairs. A just-released 7/18 Warning Letter says the specific violations were: * failure to establish and maintain a quality system
Devices
In a recent submission to the Trump administration, the Advanced Medical Technology Association (AdvaMed) outlined a series of recommendations aimed at strengthening U.S. leadership in medical technology and safeguarding national security amid reliance on imported devices, personal protective equipment and medical consumables. AdvaMed proposed the creation of a new
Drugs
FDA is laying the groundwork for a future where real-world evidence (RWE) and artificial intelligence (AI) work together to deliver better outcomes for patients and more efficient pathways for innovation. That’s the takeaway posted in a blog by Adrienne Lenz, the principal medical device regulation expert at Hyman,
Devices
FDA has issued a new safety communication warning about reports of serious complications associated with certain uses of radiofrequency (RF) microneedling devices, commonly used in aesthetic skin treatments. The devices deliver radiofrequency energy through tiny needles to heat tissue under the skin, a process marketed for skin tightening, wrinkle reduction,
Devices
FDA has cleared Roche’s Elecsys pTau 181 test, which the company says is the only blood-based biomarker test indicated as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in the primary care setting. Roche says the Elecsys pTau 181 test
Devices
FDA says it is aware that LifeVac, LLC, in Nesconset, NY, is illegally marketing its LifeVac Rescue Suction device since the device does not have agency marketing authorization. A just-released 9/18 Warning Letter says the airway clearance device is used for resuscitating a victim with an airway obstruction
Devices
FDA has approved SQ Innovation’s drug-device combination Lasix ONYU (furosemide injection) for treating edema (due to fluid overload) in adult patients with chronic heart failure. The product was developed to enable subcutaneous infusion of furosemide outside the healthcare setting for selected patients, according to the company. Lasix ONYU
Devices
FDA has cleared a Methinks AI 510(k) for its Methinks CTA Stroke, an artificial intelligence–based software tool that detects suspected large vessel occlusions (LVOs) using CT angiography scans. The software demonstrated 98.2% sensitivity and 91.6% specificity, including detection of distal occlusions up to the MCA-M2
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