Devices
Physician-attorney Jeff Shuren’s hand-picked successor Michelle Tarver has been given the reigns as the next CDRH director effective 10/22. She takes over as Shuren is receiving increased scrutiny (see story) from Capitol Hill after two U.S. House of Representatives Democrat lawmakers last month called for
Devices
FDA says a new dataset generated from studies of how people with Parkinson’s disease move has multiple benefits as a regulatory science tool. An agency post says the new dataset is from a partnership between FDA and the Johns Hopkins University School of Medicine. The post says researchers used
Devices
Well in advance of the 11/20-21 meeting of the FDA Digital Health Advisory Committee to discuss “Total Product Lifecycle Considerations for Generative AI-Enabled Devices,” FDA has published a meeting executive summary and questions the panel is being asked to discuss. The summary says that the novel capabilities
Devices
FDA has cleared an iRhythm Technologies 510(k) related to prior design changes made to the Zio AT device under a letter to file. A 5/25/2023 Warning Letter noted that the device was cleared for long-term monitoring of arrhythmia events for non-critical care patients where real-
Devices
GE Healthcare has recalled its Giraffe OmniBed neo-natal incubator after receiving reports about the screw securing the door that covers the warmer heaters may not have been torqued to specification. If it is not tight then the door could become loose. Last month, GE HealthCare issued an Urgent Medical
Devices
Boston Scientific is recalling (Class 1) its Obsidio Conformable Embolic device to update the use instructions due to a concern about risks when using it anywhere in the gastrointestinal (GI) area. A previous alert noted serious adverse health consequences that were associated with lower GI bleeding, and the company is
Biologics
FDA has published a guidance, Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development, with a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful to support a determination of the safety of a drug, biological product, or
Devices
FDA has cleared a Bracco Diagnostics and Subtle Medical 510(k) for their artificial intelligence-powered software AiMify for magnetic resonance imaging (MRI) of the brain. The software is designed to enhance brain MRIs, particularly detecting small and poorly enhanced lesions, the companies say. “AiMIFY leverages advanced AI technology to
FDA Policy/General
FDA commissioner Robert Califf and two agency colleagues say that historic advances in artificial intelligence (AI) applied to biomedicine and healthcare “must be matched by continuous complementary efforts to better understand how AI performs in the settings in which it is deployed.” Writing in a JAMA Special Communication, the authors
Devices
CDRH is piloting medical device “trial participation snapshots” to provide “key information” about clinical trials that supported the agency’s approval of a new device. The pilot is part of the agency’s efforts to increase transparency around clinical trials and diversity in clinical trial participation. It is intended to
Devices
FDA has posted recommendations for preventing the risk of damage caused by electronic interference with wearable medical devices including wearable diabetes devices, cardiac implantable devices, and neurostimulators. “FDA has received some reports of electronic medical devices being damaged during CT scans,” the post says. “Damage to the devices may be
Devices
FDA has cleared an iCardio.ai 510(k) for its artificial intelligence software EchoMeasure for interpreting echocardiography. The Los Angeles-based company develops machine and deep learning algorithms for analyzing ultrasound applications, with a specific focus on transthoracic echo, iCardio.ai says, adding that the software leverages a database of
Devices
FDA has approved an Iota Biosciences IDE for an early feasibility study of its investigational implantable device designed to deliver electrical stimulation directly to the bladder wall to induce contractions to help with bladder emptying in individuals impacted by underactive bladder (UAB). Iota says the agency granted a “staged approval”
Devices
FDA has approved Bausch + Lomb’s EnVista Envy intraocular lens (IOL), which offers a “continuous range of vision with excellent dysphotopsia tolerance” for cataract patients, according to the company. Approval was based on clinical trial data from 332 subjects. “On average, 86% of patients reported little to no bothersomeness for
Devices
FDA has posted a final guidance entitled “Endosseous Dental Implants and Endosseous Dental Implant Abutments — Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for endosseous dental implants and endosseous dental implant abutments under CDRH’s Safety and Performance-Based Pathway. Under the framework, entities planning
Devices
FDA has published a list of three final guidances and 18 draft guidances it intends to publish in FY 2024. The list also shows two final and one draft guidances the Center says will be published as guidance development resources permit. The final guidance topics it intends to publish are:
Devices
The Department of Justice says Magellan Diagnostics, headquartered in Billerica, MA, was sentenced in a Massachusetts federal court on 10/9 for criminal charges related to concealing a device malfunction that produced inaccurately low lead test results. A department statement says the company pleaded guilty to two counts of introducing
Devices
Zyno Medical is recalling (Class 1 device correction) various models of its Z-800 Infusion System because there is a defect in the air in-line software algorithm. FDA determined the cause to be related to the firm’s “process change control,” according to a recall notice. An “Urgent: Medical
Devices
FDA has approved a Procept BioRobotics IDE for a clinical trial comparing its Aquablation therapy to radical prostatectomy in men with Grade Group 1 to 3 localized prostate cancer. The trial, WATER IV PCa, will enroll up to 280 patients at up to 50 centers and follow them for 10
Devices
Sentec/Percussionaire is recalling (Class 1 device correction) its Phasitron 5 In-Line Valve to update use instructions due to an increase in reports of patient injuries after users failed to remove the blue plug from the expiratory port when applying therapy directly to a patient’s airway. “Failure to
Devices
FDA has granted a de novo marketing authorization to Healgen for its over-the-counter Healgen Rapid Check Covid-19/Flu A&B Antigen Test. The test, which is intended for use by individuals experiencing respiratory symptoms, uses a nasal swab sample to deliver at-home results in about
Devices
A 9/19-9/20 workshop sponsored by FDA and the National Institutes of Health on “Developing Implanted Brain/Computer Interface Clinical Outcome Assessments to Demonstrate Benefit” was intended to help resolve some of the hurdles that exist in commercializing that device ecosystem for brain/computer interfaces (BCI) that may