Devices
Apollo Endosurgery says it has completed a post-approval study of its Lap-Band AP Adjustable Gastric Band called HERO (Helping Evaluate Reduction in Obesity). The study began in 2009 as part of CDRH’s approval conditions for the device, which is indicated for weight reduction in obese patients. The
Devices
FDA has approved a de novo petition to allow marketing of a Becton Dickinson molecular test to detect the most common causes of vaginitis. The in vitro diagnostic is the first multiplex, real-time polymerase chain reaction assay that can detect microorganisms responsible for bacterial vaginosis, trichomoniasis and vulvovaginal candidiasis,
Devices
FDA has cleared an Onkos Surgical 510(k) for the Eleos Limb Salvage System to treat patients with significant bone loss due to cancer, trauma, or previous surgical procedures. “When replacing bone with an implant, Eleos provides the flexibility and modularity a surgeon needs for these complex cases, the company
Devices
A client alert by DLA Piper attorneys reviews when a cybersecurity-related change to a device is reportable to FDA. In particular, a correction to a device already in the field can trigger FDA reporting under 21 CFR Part 806, the alert says. “The reporting threshold is whether a correction
Drugs
A Washington Legal Foundation legal backgrounder examines the recent convictions of two Acclarent (Johnson & Johnson subsidiary) executives in U.S. v. Facteau (see story) and the questionable boundaries that currently separate speech from criminal conduct. Authored by Sedgwick attorneys Anthony J. Anscombe and Mary Beth Buckley, the backgrounder notes
Devices
FDA has approved a St. Jude Medical PMA for the Amplatzer PFO Occluder device to reduce the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart (patent foramen ovale) and then
Devices
FDA has released a guidance on “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” that addresses the necessary warnings and risk information to inform healthcare providers and patients before such procedures are performed. The guidance addresses recommendations made last year by FDA’s Obstetrics and Gynecology Devices Panel
Devices
FDA has cleared a Corindus Vascular Robotics 510(k) for the CorPath GRX, the second generation of its CorPath Vascular Robotic System. Improvements over the previous model include precision upgrades, improved workflow, and extended capabilities and range of procedures that can be performed robotically, the company says. It also features
Devices
HeartWare Inc. has begun a Class 1 recall of its Ventricular Assist Device controller due to a loose power connector which may cause the rear portion of the pump’s driveline connector to become separated from the front portion of the driveline connector. A loose connector may allow moisture to
Devices
FDA has approved a Roche PMA for the Ventana PD-L1 (SP142) Assay as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the company’s recently approved (see story) immunotherapy Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer. The assay is
Devices
FDA has cleared a SeaSpine Holdings 510(k) for its Shoreline ACS Anterior Cervical Standalone System, which features TruProfile technology. The device offers a low profile plate that is designed to minimize cephalad-caudal encroachment onto the vertebral bodies and maximize the distance from adjacent disc spaces, according to the
Devices
New funding to be phased in over the course of MDUFA 4 will be used to implement proposed MDUFA 4 enhancements. A summary of draft recommended legislative changes dated 10/25 shows new funding of $47,419,400 in FY 2018, $54,849,400 in FY 2019, $64,339,400
Devices
The Small Biotechnology Business Coalition commends FDA for its 7/27 draft guidance on using data and evidence collected outside of the traditional clinical trial context to support medical device regulatory decisions. The group suggests these additions to improve the impact and clarity of the draft: * stipulating that economic cost-
Devices
An FDA update to transplant surgeons and cardiologists says that additional data continue to indicate that there is a higher mortality rate for a subgroup of patients requiring pre-implant circulatory rescue interventions when using SynCardia’s Temporary Total Artificial Heart Companion 2 Driver System, as compared to the previous
Drugs
FDA and the European Union are moving forward with a GMP inspection mutual agreement to recognize each other’s inspectional activities, with such an agreement being finalized in January. The agreement is part of the negotiations under the Transatlantic Trade and Investment Partnership (TTIP). There are still a number of
Devices
FDA has approved Medtronic’s CoreValve Evolut R 34 mm valve, said to be the largest sized transcatheter aortic valve replacement (TAVR) system available in the U.S. The device is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size
Devices
FDA has approved an Ethicon BLA supplement for an expanded indication for Evarrest Fibrin Sealant Patch, indicated for stopping problematic bleeding during surgery. It now supports the product’s use as an adjunctive hemostat across a broad range of challenging patient types and surgical situations. Approval is based on data
Devices
FDA has cleared a Spineology 510(k) for the Rampart Duo Interbody Fusion System, which the company describes as the first device of its kind to combine PEEK (polyether ether ketone), titanium, and graft containment mesh elements. The device is designed to allow for “decreased retraction requirements when compared to
Devices
St. Jude Medical has recalled certain models of its Fortify, Unify, and Assura implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) due to reports of rapid battery failure caused by deposits of lithium (lithium clusters) forming within the battery, and causing a short circuit. “If the battery
Devices
The Yale Collaboration for Research Integrity & Transparency says it supports appropriate use of high quality real-world evidence in the context of post-market medical device regulation and surveillance. Commenting on an FDA draft guidance, on using real-world evidence to support medical device regulatory decision-making, the group
Devices
FDA says that Viracor-IBT Laboratories, Lee’s Summit, MO, is distributing a Zika Virus IgG test and Zika Virus IgG and IgM Panel without marketing clearance, approval, or authorization from the agency. A 10/21 untitled letter says that the agency issued an emergency use authorization for the firm’
Devices
AdvaMed says it appreciates FDA’s interest in providing guidance and further clarity regarding the form and content of a device’s unique device identifier (UDI). In comments on the agency’s draft guidance on the form and content of a UDI, the association says it does not agree that