Devices
CDRH says it will hold a two-day meeting of its Medical Devices Advisory Committee’s Circulatory System Devices Panel to review information about the benefit-risk profile of Endologix’s AFX endovascular graft system pertaining to Type III endoleak risks. The agency intends to request panel feedback on the
Devices
FDA has granted a de novo marketing authorization for Helius Medical’s Portable Neuromodulation Stimulator, indicated for use as a short-term treatment for gait deficit due to mild to moderate symptoms from multiple sclerosis (MS). The neuromuscular tongue stimulator comprises a non-implantable apparatus to generate electrical pulses for
Devices
CDRH’s Covid-19 experience with diagnostics will lay the foundation to expand home testing for routine medical care and future outbreaks. Writing in the 3/22 Health Affairs Blog, CDRH director Jeff Shuren and Office of In Vitro Diagnostics and Radiological Health director Tim Stenzel say progress in advancing
Devices
FDA has approved a Medtronic PMA for its Harmony Transcatheter Pulmonary Valve (TPV), the first minimally invasive therapy created to treat patients with a specific type of congenital heart defect of the right ventricle that makes it difficult for blood to travel from the heart to the lungs. The company
Devices
FDA has cleared a Rapid Medical 510(k) for its TigerTriever revascularization device for use in treating ischemic stroke. The stent retriever offers intelligent control, enabling neuro interventionalists to better remove blood clots and restore blood flow in the brain following an ischemic event, according to the company. Clearance was
Devices
FDA has cleared an Aurora Spine 510(k) for its proprietary Apollo Anterior Cervical Plate system, featuring a 1.9mm design with hyper-angulation variability in the Cephalad Caudal and screw angulation of 32 degrees. The company says the device is designed to help reduce common postoperative complications — such as
Devices
A multi-state settlement with Boston Scientific Corp. will require it to pay $188.6 million to 47 states and the District of Columbia to settle allegations that it deceptively marketed its transvaginal surgical mesh devices to patients. A statement issued by the California Department of Justice says the state
Devices
FDA has granted Tempus a breakthrough device designation for its artificial intelligence electrocardiogram (ECG) Analysis Platform. The device, which was developed in collaboration with Geisinger, is intended to aid clinicians in identifying patients at increased risk of developing atrial fibrillation (AFib) or atrial flutter. It was designed for use with
Devices
An Alabama federal court has granted summary judgment to Sanofi-Aventis on both medical causation and preemption grounds in a case involving a Class 3 medical device that is a gel-like substance injected into a knee to reduce pain. Attorney Michelle Yeary (Dechert) writes in an online post that
Devices
FDA has cleared a Recovery Force 510(k) for the Movement and Compressions System, a data-driven mobility measurement device designed for hospital and home use. The device provides therapeutic compressions to the lower leg and displays real-time patient mobility data. According to the company, it provides bedside caregivers
Devices
FDA has granted Tiger Tech Solutions an emergency use authorization for the first machine learning-based Covid-19 non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation. The device identifies certain biomarkers that may be indicative of Covid-19 infection
Devices
FDA has announced a 5/4 virtual public meeting entitled “Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices.” Sources of patient generated data, data quality measures, interoperability, and potential impacts of the data in regulatory and healthcare settings will be discussed during the meeting. To
Devices
FDA has cleared a Life Spine 510(k) for the Prolift Wedge Expandable Spacer System, described as a lordotic expandable implant for micro-invasive transforaminal lumbar interbody fusion back surgery and posterior lumbar interbody fusion procedures. “The device maintains coronal alignment while achieving sagittal correction through controlled lordotic expansion of
Devices
FDA says a 1/18 recall of the ACIST Kodama intravascular ultrasound catheter due to risk of broken O-ring pieces flushing into arteries during use is Class 1. The device uses ultrasound waves to view the inside of an artery, including its structure, and any devices such as stents.
Devices
FDA has granted BioFire Diagnostics a De Novo marketing authorization for the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of Covid-19 and other respiratory
Drugs
FDA acting commissioner Janet Woodcock and associate commissioner for regulatory affairs Janet McMeekin say the agency has used alternative oversight tools when the pandemic prevented investigators from entering facilities for inspections. Writing in an FDA Voice post, the two say the agency prioritized “mission-critical” inspections on a case-by-
Devices
CDRH has published an analysis of its experience in using real-world evidence (RWE) in regulatory decisions to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market. In an online
Devices
Stakeholders are questioning the advisability of a 1/15 HHS notice stating that it is planning to exempt specified medical devices from 510(k) requirements, for which premarket review had been waived during the Covid-19 public health emergency. HHS said it wanted input on whether premarket review should be
Devices
FDA has cleared a Catalyst OrthoScience 510(k) for its reverse shoulder system. The total shoulder prosthesis is designed for patients experiencing severe shoulder arthritis in conjunction with a grossly deficient or non-functional rotator cuff, the company says. “In a reverse shoulder system, the design is inverted compared to
Devices
KEB consultant Adam Atherton says his analysis of FDA quality system inspection data over time yielded three takeaways to ensure future success. In a Med Device Online guest column, Atherton says agency inspections of medical device quality systems are driven by either the older, but still relevant, quality system inspection
Devices
CDRH says it is providing information to test developers about a streamlined path for emergency use authorization (EUA) for Covid-19 tests and information to assist in setting up testing programs. An online notice (contains links to documents) says FDA issued a new supplemental template for test developers seeking EUA
Devices
FDA has issued a safety alert on Stryker’s Scandinavian Total Ankle Replacement device due to a higher than expected risk of the device’s polyethylene (plastic) component breaking as early as three to four years after implantation. “Fracture of the plastic component of the STAR Ankle may lead to