Devices
A federal court has approved an FDA-brokered consent decree against Philips Respironics over its defective continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines, and other devices. CDRH director Jeff Shuren calls the action a significant milestone, as it “marks the first time a device
Devices
FDA has granted Onkos Surgical a de novo marketing authorization for its novel antibacterial coated implants. The authorization is based on preclinical safety and efficacy data showing that the “proprietary coating does not elute and has been proven to be bactericidal, with a 99.999% (5 log) kill rate in
Devices
Honeywell Safety Products is recalling its Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station after a supplier of the cartridge was found to be non-compliant with GMP requirements. “Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range
Devices
Some 31 experts in genetics, addiction, psychiatry, public health, and medical device regulation are asking FDA to revoke its 1/2 approval of AutoGenomics’ AvertD, the first test to use DNA to assess whether individuals may have an increased risk of developing opioid use disorder (OUD). In a 4/4
Devices
CDRH says it issued 45 safety-related communications between 1/1/2022 and 12/31/2022. In a report to Congress mandated by the Consolidated Appropriations Act of 2023, which was posted six months past its due date, CDRH says there were 30 Medical Device Safety Communications and 15 Letters
Devices
FDA says the 2/2 Medos International Sàrl recall of the Cerenovus Cerebase DA guide sheath neurovascular catheter is Class 1. The company recalled 1,343 devices in the U.S. An FDA notice says the company recalled the sheaths after complaints describing fractures of the distal catheter shaft. Using
Biologics
Four Hogan Lovells attorneys say a discussion paper published by CBER, CDER, CDRH, and the Office of Combination Products on artificial intelligence (AI) and medical products aims to provide greater transparency on how the agency’s Centers are collaborating to safeguard public health while fostering responsible and ethical innovation. The
Devices
FDA has approved Abbott’s TriClip, which it describes as a “first-of-its-kind” transcatheter edge-to-edge repair system that is designed for treating tricuspid regurgitation (leaky valve). Approval is based in data from the TRILUMINATE Pivotal trial that evaluated the safety and effectiveness of the TriClip system
Devices
FDA says it has qualified a new tool for the evaluation of lethal arrhythmia alarm detection algorithms used in hospital-based patient monitoring systems. An online announcement says that under the Medical Device Development Tools program, the University of California San Francisco Lethal Arrhythmia Database Medical Device Development Tool was
Devices
FDA has granted Prenosis a de novo marketing authorization for its Sepsis ImmunoScore artificial intelligence (AI)/machine learning software as a medical device to guide rapid diagnosis and prediction of sepsis. The company says this is the first authorization of an AI diagnostic tool for sepsis, a “complex condition that
Drugs
AdvaMed says it appreciates that FDA issued a revised draft guidance on questions and answers about conducting remote regulatory assessments (RRA) and continues to support the concept of RRAs. In its comment letter, AdvaMed says it is “important that RRAs be implemented in a manner that both serves FDA’s
Devices
FDA says its 6/7-6/13/2023 inspection at Agena Bioscience in San Diego, CA, determined that the firm manufactures the MassARRAY4 system and iPLEX HS chemistry panels in vitro diagnostic products, including the iPLEX HS colon panel. A 3/21 Warning Letter says the colon panel is adulterated
Devices
An 11/1-12/11/2023 FDA inspection at the Beckman Coulter facility in Chaska, MN, found Quality System Regulation violations in the firm’s manufacturing of the DxI 9000 Access Immunoassay analyzer instrument system and assays. A 3/15 Warning Letter says specific violations were: * failure to adequately establish
Devices
FDA appears to be increasing scrutiny over CooperSurgical and its manufacturing facility in North Tonawanda, NY, where Paragard (intrauterine copper contraceptive) is made, according to a report by Spotlight on America, which describes itself as “a national award-winning investigative news franchise airing on 90+ ABC, CBS, NBC, FOX, CW
Devices
FDA has cleared a Baxter International 510(k) clearance for its Novum IQ large volume infusion pump (LVP) with Dose IQ safety software. “Adding LVP modality to the Novum IQ Infusion Platform – which includes Baxter’s syringe infusion pump (SYR) with Dose IQ safety software, powered by the IQ Enterprise
Devices
FDA has cleared Abbott’s i-STAT TBI (traumatic brain injury) cartridge to be used with whole blood to assess patients with suspected concussion at the patient’s bedside within 15 minutes. Previously, tests to help assess TBI were only cleared for use with plasma or serum, requiring samples to
Devices
Thoratec has recalled (Class 1) its HeartMate Touch Communication System due to software design issues. The Touch application is intended to be loaded onto a tablet to provide a user interface with hardware/software platforms for supporting left ventricular assist device (LVAD) patients, according to Thoratec. The application also introduces
Devices
FDA has approved Roche’s cobas malaria test for use on the cobas 6800/8800 Systems to aid healthcare professionals in reducing potential risks of patient infection from transfused blood products. The test provides a “highly sensitive and specific solution to help ensure that infected blood units are removed from
Devices
FDA has published a draft guidance, Animal Studies for Dental Bone Grafting Material Devices—Premarket Notification (510(k)) Submissions, with recommendations for animal studies that may assist manufacturers in complying with some special controls for dental bone grafting material devices. The document says the device is a material that is
Devices
The Accreditation Scheme for Conformity Assessment (ASCA) consolidated pilot final report issued by CDRH says the pilot, which began in 2020, “met and in some cases exceeded program expectations.” The report says that while the pilot called for the inclusion of five consensus standards, the program now includes 80 recognized
Devices
FDA has cleared a Synaptive Medical 510(k) for its near-infrared fluorescence visualization module, Modus IR, adding to the existing fluorescence offering on its 4K 3D robotic exoscope, Modus X, for use in neurosurgical procedures, as well as in plastic and ear, nose and throat surgery. The company says
Devices
Boston Scientific has recalled the PolarSheath Steerable Sheath 12F after the company identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of devices. If delamination should happen, this could result in the embolization of a fragment during