Devices
Abbott is recalling (Class 1) its HeartMate Mobile Power Unit (MPU) because of instances where the device experiences a sudden power loss. A recall notice says the company has received reports in which the MPU experienced sudden, unexpected performance issues such as not turning on, unprompted shutdown, or suddenly turning
Drugs
The Association for Clinical Oncology (ASCO) has written to the new heads of FDA, the National Institutes of Health, and the Centers for Medicare and Medicaid Services to ensure continued progress in cancer care, research, and patient access. An ASCO statement says that in its letter to FDA commissioner Martin
Devices
An FDA alert says Conavi has sent an “Urgent Medical Device Product Removal” notice to customers about removing certain Novasight hybrid catheters from the market. The action is based on one reported incident involving the device’s sheath detaching from the catheter during use and was left in the patient’
Devices
FDA has granted CereVasc a breakthrough device designation for its investigational eShunt System and its use in treating communicating hydrocephalus in pediatric patients aged 12 years and older. The action was supported by data generated during pilot clinical studies, as well as original research published in the Journal of NeuroInterventional
Devices
A 7/23-8/9/2024 FDA inspection at Smiths Medical ASD, in Minneapolis, MN, which was acquired by ICU Medical in 1/2022, determined that the firm manufactures two infusion pumps that are adulterated because the company does not have an approved PMA or IDE for them and are
Devices
A 10/28-11/26/2024 FDA inspection at Noah Medical Corporation in San Jose, CA, found Quality System Regulation violations in the firm’s manufacturing of the Galaxy System bronchoscopes and accessories. A 4/9 Warning Letter says the specific violations were: * failure to establish and maintain procedures for
Devices
Bard Access Systems, a Becton Dickinson subsidiary, has recalled (Class 1) its BD 4 Fr. Single Lumen PowerPICC Catheters due to tubing that exceeded melt flow index specifications, which could lead to increased material fatigue leaks. These leaks could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body
Devices
Q’Apel Medical is recalling (Class 1) and discontinuing the marketing of its 072 Aspiration System (also known under the product name “Hippo” and “Cheetah”) based on a recent Warning Letter that raised questions about whether the features and characteristics of the catheter’s distal tip were within the scope
Devices
FDA has issued two documents with answers to frequently asked questions about medical device recalls and reports of corrections and removals. The first, Medical Device Recalls and Reports of Corrections and Removals, Part 7, Part 806: Frequently Asked Questions answers common questions about medical device recalls and reports of medical
Devices
Three CDER and Digital Health Center of Excellence staffers say advancing the use of digital health technologies (DHTs) is a priority for FDA. “We recommend engaging early with FDA when planning to integrate DHTs into a clinical investigation to design a trial that will provide meaningful results,” the three write
Devices
FDA has granted Click Therapeutics a de novo marketing authorization for its prescription digital therapeutic, CT-132, which it describes as the first prescription digital therapeutic for preventing episodic migraine. The company says it is intended for adjunctive use alongside acute or other preventive treatments for migraine. The device “delivers
Devices
FDA has cleared a TytoCare 510(k) for its Tyto Insights for Rhonchi Detection, an artificial intelligence (AI)-based device for detecting, during a virtual exam, all three major abnormal lung sounds — wheezes, crackles, and rhonchi. The company says the the diagnosis of these abnormal lung sounds presents a recognized
Drugs
Researchers from FDA and several hospitals say there is increasing interest in using patient-reported outcomes (PROs) as endpoints in heart failure trials and regulatory bodies have shown a willingness to consider heart failure drugs and devices for approval based on improvement in PROs. Writing in the journal Circulation, the
Devices
Harmed Americans for Reforms in Medical Device Safety (HARMS) is asking FDA to recall all Humacyte Symvess vascular graft products and withdraw its approval of the Symvess BLA. The 4/10 petition cites eight cases with ATEV (acellular tissue-engineered vessel) blowouts or disruptions generally associated with major, life-threatening
Devices
FDA has cleared a Bright Uro 510(k) for its Glean Urodynamics System, a wireless, catheter-free ambulatory urodynamics device designed to support clinical decision-making for patients with lower urinary tract dysfunction. About 80 million Americans suffer from voiding problems, including overactive bladder, urinary incontinence, enlarged prostate and neurogenic
Devices
Daxor Corp. has filed a 510(k) seeking FDA clearance for its next-generation blood volume analyzer, Daxor BVA. The new device “represents a significant leap forward in diagnostic technology, offering direct quantification of intravascular blood, red blood cell, and plasma volume,” according to the company. It says that compared
Devices
FDA has cleared the Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System for people over age 18 with diabetes in the U.S. A company statement says the G7 15 Day is the longest-lasting CGM system with 15.5 days of wear. The company says the system has
Devices
FDA has cleared an Intuitive 510(k) for the SP SureForm 45 stapler for use with its da Vinci SP surgical system in thoracic, colorectal, and urologic procedures. The device features the company’s SmartFire technology, which continuously monitors tissue compression before and during firing,” the company says, adding that
Devices
FDA has cleared a Zeiss Medical Technology 510(k) for its Intrabeam 700, a robotic-assisted platform to support intraoperative radiation therapy for use in neurooncology and breast cancer therapy. In oncological treatments, the device ensures that the target area is optimally resected, and that healthy tissue is spared as
Devices
FDA approved nine new or substantially changed high-risk medical devices in the first quarter of 2025, the lowest number of approvals in 10 years. The Minneapolis Star Tribune reports there were 13 such devices approved in the comparable period in 2024 and 14 in 2023. The newspaper says the
Devices
An 11/12-12/13/2024 FDA inspection at EpiCare Acquisitions in Lawrenceville, NJ, found Quality System Regulation and other violations in the firm’s manufacturing of the EpiCare-Zenith family of laser systems. A just-released 3/21 Warning Letter says the specific violations were: * failure to establish and
Devices
Bausch + Lomb has recalled its enVista intraocular lenses (IOLs) after the company received reports of complications, which it says could not immediately be explained. “The recall is in response to an increased number of reports of toxic anterior segment syndrome, and includes all lots of enVista Aspire, enVista Aspire Toric,