Devices
FDA says it has determined that biocompatibility testing labs Mid-Link Technology Testing and Sanitation & Environment Technology Institute of Soochow University dba SDWH have in several instances copied the results of another study or created falsified or otherwise invalid data that were submitted to the agency. Until the firms
Devices
A 9/23-10/4/2024 FDA Bioresearch Monitoring Program inspection at United Health Products in Mt. Laurel, NJ, identified serious violations in the firm’s conduct of research involving the CelluSTAT absorbable hemostat. A just-released 3/24 Warning Letter says the specific violations were: * failure to submit an
Devices
A 1/6-2/5 FDA inspection at the NeuroSync facility in Holliston, MA, found Quality System Regulation violations in the firm’s manufacturing of the Eye-Sync eye assessment virtual reality headset and tablet computer. A 5/9 Warning Letter says the specific violations were: * failure to establish and
Devices
Johnson & Johnson’s Ethicon Endo-Surgery has recalled (Class 1) its Endopath Echelon Vascular White Reload for Advanced Placement Tip surgical stapler due to increased reports regarding inadvertent instrument lockout during surgical procedures involving the device. “If lockout occurs, the device will momentarily activate but will not cut or
Devices
A 1/14-2/18 FDA inspection at the Microspecialties facility in Middletown, CT, found Quality System Regulation violations in the firm’s work as a contract manufacturer of several Class 1 and 2 ophthalmic surgical devices. A 5/8 Warning Letter says the specific violations were: * failure to establish
Devices
Zynex has submitted a 510(k) for its NiCO, Noninvasive CO-Oximeter device which the company says was designed to address problems with current devices on the market that have been scrutinized for their inaccuracy and limitations. “Zynex's laser technology enables oxygen levels to be measured accurately for
Devices
FDA has cleared a Stryker 510(k) for its OptaBlate basivertebral nerve ablation (BVNA) system and its use for procedures providing vertebrogenic pain relief. BVNA is described by the company as a minimally invasive and innovative procedure that targets a key source of this pain, particularly in patients with specific
Devices
FDA has cleared a Fujirebio Diagnostics 510(k) for the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is intended to detect amyloid plaques associated with Alzheimer’s disease in adult patients aged
Devices
FDA has approved Roche’s Ventana MET (SP44) RxDx Assay, a companion diagnostic to aid in determining MET (also known as c-Met) protein expression in lung cancer patients to determine eligibility for AbbVie’s just-approved Emrelis (see earlier story). The device detects the MET protein and is scored
Devices
Nipro Renal Soultions has recalled (Class 1) its MedicaLyte Liquid Bicarbonate Concentrate, a dialysate concentrate for hemodialysis, due to the potential for the presence of visible foreign matter in the plastic bottles. Nipro Renal notified consignees on 4/11 through a “Urgent: Medical Device Recall” letter that instructed them to
Devices
FDA has cleared a BrightHeart 510(k) for the B-Right Views, an artificial intelligence (AI)-powered tool that automatically detects the standard views required for second- and third-trimester fetal heart ultrasound evaluations within routine anatomy scans. “The software supports fetal heart exams by confirming when all recommended views
Devices
FDA has cleared a Capillary Biomedical 510(k) for its SteadiSet, a wearable infusion set that delivers insulin from a pump to the body for up to three days of use in Type 1 diabetes patients. The device features an integrated inserter with a hidden needle designed for one-handed
Devices
FDA has approved GE HealthCare’s ultrasound imaging agent Optison 9 (perflutren protein-type a microspheres injectable suspension) for use in pediatric patients. The drug, which contains gas-filled microbubbles that enhance the visibility of heart chambers and walls during ultrasound imaging, was previously approved for adult use in 1997.
FDA Policy/General
FDA and HHS have launched a public Request for Information to “identify and eliminate outdated or unnecessary regulations.” An FDA statement says the initiative is part of a broader federal effort to reduce regulatory burdens and increase transparency in line with President Donald J. Trump’s Executive Order on “Unleashing
Devices
FDA has cleared a United Imaging 510(k) for its first interventional X-ray system, uAngio Aviva. The company says the “intuitively bionic ceiling-mounted system” uses intelligent robotics, voice control, vision and imaging to assist clinical staff. United Imaging describes the eight-axis robotic system as offering flexibility to
Devices
FDA has approved a Teal Health PMA for the Teal Wand, the first at-home vaginal sample, self-collection device for cervical cancer screening. The prescription device is indicated for women aged 25–65 at average risk, according to the company. The at-home screening includes a collection kit and
Drugs
The FDA Office of Inspections and Investigations (OII) Ombudsman Program recommends that the agency explore developing a Stakeholder Education Hub, perhaps as a dedicated Web page that brings together existing educational resources organized around common concerns in a question-and-answer format. The recommendation is included in the program’s
Devices
FDA has given Orchestra BioMed the green light to begin a pivotal clinical trial evaluating its next generation Virtue Sirolimus-AngioInfusion Balloon (Virtue SAB) for treating coronary in-stent restenosis. The agency approved a study design amendment allowing a head-to-head trial comparing Virtue SAB to the only FDA-
FDA Policy/General
FDA commissioner Michael Makary says the agency will expand the use of artificial intelligence (AI)-assisted scientific reviews across all Centers by 6/30. In a statement, he says the rollout follows the successful completion of a new generative AI pilot for scientific reviewers. “I was blown away by the
Devices
SS Innovations says it will seek a de novo marketing authorization in July for its SSi Mantra 3 surgical robotic system for multiple indications. The modular, multi-arm system is designed with many advanced technology features, according to the company, including three to five modular robotic arms, an open-faced
Drugs
FDA says it will expand unannounced inspections at foreign manufacturing facilities that produce medical products, drugs, and food intended for U.S. consumers and patients. A 5/6 statement says the intent is to “ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic
Devices
FDA has cleared a Teleflex 510(k) for an expanded indication for its QuikClot Control+ Hemostatic Device to include all grades of internal and external bleeding. The device was previously indicated for temporary control of Class III and Class IV internal organ space bleeding, severely bleeding surgical wounds, mild and