Devices
FDA has cleared a Quidel 510(k) for its Sofia 2 Lyme Fluorescent Immunoassay and its use with the Sofia 2 Fluorescent Immunoassay Analyzer for rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from finger-stick whole blood specimens to aid in Lyme disease diagnoses. “Sofia
Drugs
FDA is modernizing its overall approach to regulation to effectively advance the kinds of medical innovations that are becoming available, according to FDA commissioner Scott Gottlieb. In a lengthy FDA Voice blog post, Gottlieb says the changes, including modernizing organization of the medical product review programs, are part of the
Devices
University of California, San Francisco, School of Medicine researchers say that to best ensure safety and effectiveness of high-risk medical devices, FDA should require high quality data under its new breakthrough devices program designation. In a JAMA Internal Medicine Research Letter, they also call on the agency to ensure
Devices
FDA has released an 8/24 Zimmer Biomet Warning Letter that the company disclosed last week (see story). The letter notes that the inspection, which was a follow-up to a 2016 inspection at the firm’s Warsaw, IN device manufacturing facility, “revealed continuing, significant violations of the quality system
Devices
FDA has cleared a Ceterix Orthopedics 510(k) for an added feature to the NovoStitch Pro Meniscal Repair System — a size 0 suture cartridge. The NovoStitch Pro system enables surgeons to place stitches arthroscopically in tight joint compartments, allowing them to address meniscal tears which have not been amenable to
Devices
CathWorks has submitted a 510(k) for its CathWorks FFRangio System, a fractional flow reserve (FFR) device that is intended to deliver objective multi-vessel physiologic measurements to optimize and confirm intraprocedural percutaneous coronary intervention therapy decisions. “The FAME trials clearly demonstrated the clinical and economic value of FFR in
Devices
FDA 8/24 sent a Warning Letter to a Zimmer Biomet subsidiary’s manufacturing facility in Warsaw, IN over GMP issues documented in an April inspection. “We have provided written responses to the FDA detailing corrective actions underway to address the FDA’s observations and have provided, and will continue
Devices
FDA has granted Dthera Sciences a breakthrough device designation, for its Alzheimer’s treatment, DTHR-ALZ. If approved , the device would become the first non-pharmacological prescription treatment for Alzheimer’s symptoms. It is intended for use in mitigating the symptoms of agitation and depression associated with major neurocognitive disorder
Devices
FDA has classified as Class 1 a bioMerieux recall of its Vitek 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards due to false results for some strains of methicillin-resistant Staphylococcus aureus (MRSA). A recall notice says the recall was ordered because of false negative or false susceptible results for
Devices
FDA has approved Roche’s cobas EGFR Mutation Test v2 as a companion diagnostic test for selecting patients suitable for AstraZeneca’s Iressa (gefitinib) in treating non-small cell lung cancer (NSCLC). The cobas test is currently the only FDA-approved diagnostic test for NSCLC using liquid biopsy. Epidermal growth
Biologics
FDA has published a draft guidance, Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment, to assist sponsors who are developing medical products to treat the underlying pathophysiology and structural progression of osteoarthritis. The document says that approvals for osteoarthritis to date have been based
Devices
FDA has cleared a MagVenture 510(k) for a faster treatment protocol for its Transcranial Magnetic Stimulation and its use in treating depression. The company says the protocol, called Theta Burst Stimulation, will cut treatment time to three minutes per session compared with up to 37 minutes. The FDA clearance
Devices
FDA has cleared a Gynesonics 510(k) to market its Sonata Sonography-Guided Transcervical Fibroid Ablation System. The ultrasound system with a proprietary radiofrequency ablation device “provides a transcervical, incision-free, uterus-preserving treatment for uterine fibroids,” the company says. The device exceeded “FDA-specified 12-month primary endpoint performance
Devices
FDA has cleared a Techlab 510(k) for the H. Pylori Quik Chek and the H. Pylori Chek tests that are intended to aid in diagnosing H. pylori infection. Quik Chek is a rapid diagnostic test that detects H. pylori in 30 minutes, whereas the Chek test is a 96-
Devices
FDA has cleared a UVision360 510(k) for the Luminelle DTx Hysteroscopy for use in both hysteroscopy and cystoscopy procedures. The device allows physicians to see the uterus’ internal lining from an “optimal distance with clarity thus enabling identification of suspicious tissue, perform a biopsy under visualization, and offer a
Devices
bioMerieux has recalled its Vitek 2 AST P631 after customer reports indicate an increase in the rate of non-detected methicillin-resistant Staphylococcus aureus. The automated system comprises instruments, software and reagent cards designed for antimicrobial susceptibility testing of bacteria and yeast.
Devices
An FDA review of a post-approval study conducted by SynCardia Systems for its Temporary Total Artificial Heart Companion 2 Driver System (C2 Driver System) has shown a higher mortality rate and higher stroke rate for patients initially supported with the device compared to patients initially supported with the previous
Devices
FDA has granted Brainsway de novo marketing clearance for its Deep Transcranial Magnetic Stimulation System for treating obsessive compulsive disorder (OCD). The device uses magnetic fields to stimulate nerve cells in the brain. It was originally cleared in 2008 for treating major depression, and in 2013 it was cleared for
Devices
FDA says it is launching three new initiatives under the recent MDUFA reauthorization to support medical device development, innovation, and safety. The first change is the Voluntary Malfunction Summary Reporting Program under which manufacturers will be able to report certain medical device malfunctions in a quarterly summary rather than individually.
Devices
FDA has released the FDA-483s issued following a 11/14-11/18/16 and 5/15-5/19/17 inspection at Zhejiang Huahai Pharmaceutical Co., Zhejiang, China, an active pharmaceutical ingredient manufacturer that is the reported manufacturer of the active ingredient in recalled valsartan-containing products. Observations in the
Devices
An online article in Healthcare IT News says FDA and the medical device industry “are moving in the right direction” on medical device security, “fueled by the open dialog and FDA guidance on disclosures.” The article notes that medical device vendors reported 400% more vulnerabilities per quarter since FDA released
Devices
The BRIDGE Coalition (Bringing Real-world Insight for Device Governance and Evaluation), a coalition of medical device companies, says it supports the increased institutional review board flexibility included in a draft FDA guidance on the humanitarian device exemption (HDE) program. It also supports the agency’s efforts to further define