Devices
FDA says a July Medtronic recall of some Medtronic McGrath MAC Video Laryngoscopes to remove them from where they are used or sold is Class 1. The company also issued a recall updating instructions for using other models of the devices without removing them. An agency notice says the recalls
Devices
Breas Medical is recalling (Class 1) its Vivo 45 LS ventilators to update the use instructions after internal testing of the devices identified the potential for a short-term increase in formaldehyde exposure for people using new ventilators for the first time. “The use of affected product and short-term
Devices
Baxter is recalling (Class 1) certain Volara Single Patient Use Circuits and Blue Ventilator Adapter Assemblies due to reports that the components’ handset plugs may disconnect from the nebulizer port. “When using the Volara system in line with a ventilator and without a nebulizer connected to the blue ventilator adapter,
Devices
In a new motion, the American Clinical Laboratory Association, HealthTrackRx Indiana, and HealthTrackRx, Inc., are asking a Texas federal court to grant summary judgment in favor of their 5/29 suit against FDA and vacate the FDA 5/4 final rule asserting oversight over laboratory-developed tests. In their latest
Devices
FDA has cleared a Zynex 510(k) for its TensWave device for managing pain. The transcutaneous electrical nerve stimulation therapy is intended for use in reducing chronic and acute pain, according to the company. It says the device offers a user-friendly, portable design that can be easily integrated into
Devices
FDA has cleared a Ventis Medical 510(k) for the VM-2000, an emergency transport ventilator that allows medical personnel to provide respiratory support with robust volume and pressure control modes in the field. The company says the battery-operated device weighs less than many standard laptop computers. It features
Devices
Politico says that while concern about FDA regulation of artificial intelligence (AI) tools in medicine is growing, there is no shortage of people with ideas for improving the regulation. An online column cites a study by University of North Carolina researchers who looked at 521 FDA-authorized AI medical devices
Devices
FDA has cleared an Embecta 510(k) for its proprietary Disposable Patch Pump for Insulin Delivery, intended for use by adults who require insulin to manage diabetes, including Type 1 and Type 2. The device features a tubeless patch pump design with a 300-unit insulin reservoir, which was designed
Devices
Tandem Diabetes Care says it is recalling version 2.7 of the Apple iOS t:connect mobile app used in conjunction with the t:slim X2 insulin pump with Control-IQ technology, and replacing it with app version 2.8.2. FDA says the recall is Class 1. A company
Devices
FDA has approved a Renata Medical PMA for its Minima Growth Stent that’s intended for treating congenital heart disease in neonates, infants, and young children. The device is designed to be “re-expanded” over the course of the patients’ growth period. The stent is indicated for treating vessel narrowing
Devices
FDA has sent Warning Letters to three companies marketing CPAP cleaning/sanitizing products without agency clearance or approval. The letters were sent on 8/7 or 8/8 to Shenzhen Moyeah Intelligent Life Technology Co. in Guangdong Sheng, China; Leel Tech in Guandong Sheng, China; and Adventure Innovations in South
Devices
FDA has published a guidance, Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers, to help manufacturers better understand and use the program. The agency says the document is intended to further explain, but not change, the conditions of the VMSR program. The guidance “describes and clarifies several aspects of the
Devices
Abbott Diabetes Care has begun a Class 1 recall (device correction) of its FreeStyle Libre 3 sensors based on users reporting situations where they were receiving erroneously high glucose results. “The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose
Drugs
Three stakeholders are recommending changes to an FDA draft guidance on the agency’s platform technology designation program. The National Organization for Rare Disorders (NORD) says the platform technology designation “is a promising regulatory tool of significant potential value to the rare disease community.” It suggests ways to improve the
Devices
FDA has approved an llumina PMA for its in vitro diagnostic TruSight Oncology Comprehensive test for two companion diagnostic indications. This single test “interrogates” over 500 genes to profile a patient’s solid tumor, “helping to increase the likelihood of identifying an immuno-oncology biomarker or clinically actionable biomarkers that
Devices
A group of researchers led by Duke Heart Center’s Sammy Chouffani El Fassi analyzed over 500 recent medical artificial intelligence-driven devices that showed about half of them lacked reported clinical validation data. Their findings were published in Nature Medicine on 8/26. “Although AI device manufacturers boast of
Devices
FDA has escalated its surveillance of iRhythm Technologies based on a second Form FDA-483 issued last month at the company’s Cypress, CA manufacturing facility that was simultaneously inspected with its San Francisco facility, which also ended with an FDA-483 (see earlier story). Presumably, the inspections are related
Devices
Public Citizen’s Health Research Group is calling on HHS’ Office of Inspector General to launch an investigation into allegations that retiring CDRH director Jeff Shuren failed to recuse himself from potential conflict-of-interest matters involving medical device firms being represented by his wife’s law firm. An 8/
Devices
Inari Medical has begun a Class 1 recall to update the use instructions for its ClotTriever XL catheter after discovering serious adverse events caused when the device becomes entrapped or blocks the lung arteries (pulmonary emboli). A recall notice says affected devices may cause serious adverse health consequences, including device
Devices
FDA has published a guidance, Electronic Submission Template for Medical Device De Novo Requests, to introduce de novo request submitters to the current resources and associated content developed and made publicly available to support de novo electronic submissions to FDA. The document, FDA says, is “intended to represent one of
Devices
FDA has given 510(k) clearance to Procept BioRobotics’ Hydros Robotic System for aquablation therapy. A company statement says Hydros is a next-generation artificial intelligence (AI)-powered platform. Aquablation therapy is used in the treatment of benign prostatic hyperplasia, the company says. It says the Hydros system provides AI-
Devices
Defibtech has begun a Class 1 recall of its RMU-2000 ARM XR Chest Compression Devices due to a motor problem that may cause them to stop compressions. “The use of affected products may cause serious adverse health consequences, including patient injuries, delay of therapy and death due to a