Devices
FDA has released a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers.” The document provides information on the most frequently asked questions regarding the transfer or sale of a 510(k) clearance from one application holder to another. It discusses topics related to a
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A roundtable of experts convened by the Government Accountability Office (GAO) says HHS should have a coordinated national approach to diagnostic testing for pandemic threats. A GAO report outlines steps FDA and other HHS units can take to support such an approach. While the roundtable suggested nearly 100 actions HHS
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Having failed to appeal a federal court decision vacating the laboratory-developed test (LDT) rule it proposed, FDA has accepted that it does not have a role in regulating such tests. That’s the view of attorneys Steven Gonzalez and Allyson Mullen (both Hyman, Phelps & McNamara) in a post
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FDA has given de novo authorization to Clarity’s Clarity Breast, described as a “novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram.” A company statement says most risk assessment models rely heavily on age and family history to predict risk.
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FDA has cleared a Hyperfine 510(k) for its next-generation AI-powered portable MRI system for the brain, the Swoop system. The clearance includes a new portable MRI scanner powered by the proprietary Optive AI software that helps to deliver high image quality and functionality, according to the company.
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FDA has granted BiVACOR a breakthrough device designation for its titanium Total Artificial Heart (TAH). The designation supports the BiVACOR TAH as a bridge to transplant (BTT) for adults with severe biventricular or univentricular heart failure where current treatments, including a left ventricular assist device, are not viable, according to
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An 11/4-11/7/2024 FDA inspection at DRG Instruments GmbH in Marburg, Germany, found multiple violations in the firm’s manufacturing of several in vitro diagnostic devices. A just-released 3/31 Warning Letter says two of the firm’s diagnostic devices are adulterated because DRG does not
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FDA has published one final and one draft guidance on aspects of its medical device Q-Submission program. The final guidance Request for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program gives an overview of the mechanisms available to submitters through which they can request interactions with
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A 1/20-1/24 FDA inspection at Sedecal S.A. in Madrid, Spain, found Quality System Regulation violations in the firm’s manufacturing of mobile digital radiography systems. A 5/5 Warning Letter says the specific violations were: * failure to adequately establish and maintain procedures for implementing corrective and
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FDA has issued a Warning Letter to Kabe Labortechnik, the North Rhine-Westphaia, Germany-based manufacturer of the RAM Scientific SAFE-T-FILL Capillary Collection System tubes distributed by ASP Global that are linked to a safety alert issued last month on reports of falsely elevated (false positive) results that
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FDA has given 510(k) clearance to the Olympus EZ1500 series endoscopes that the company says feature extended depth of field (EDOF) technology. A company statement says the series’ gastroscope and colonoscope “represent Olympus’ most advanced imaging and latest innovation as part of the EVIS X1 endoscopy system. By allowing
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BD has recalled (Class 1 device correction) its Esophagogastric Balloon Tamponade Tubes to update the device’s instructions for use due to difficulties in removing plastic plugs from its rubber lumen to inflate the balloons. In some cases, the devices may become damaged during removal of the plastic plugs in
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Centerline Biomedical has recalled (Class 1) its Intra-Operative Positioning System’s (IOPS) Guidewire 2, a sensorized wire used to navigate through a patient’s vasculature to help accurately place a catheter. A recall notice says that the company has determined that the coating on the guidewires for lot# 2404-
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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
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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
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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
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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
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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
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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
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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
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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
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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