Devices
FDA has approved a Shockwave Medical PMA for its Intravascular Lithotripsy (IVL) to treat severely calcified coronary artery disease. The sonic pressure wave therapy is intended to pass through soft arterial tissue to disrupt calcified plaque by creating a series of micro-fractures. “After the calcium has been cracked, the
Devices
CDRH director Jeffrey Shuren and Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel say that knowing what they know now, they would not have permitted SARS-CoV-2 serology tests to be marketed without FDA review and authorization. Writing in a New England Journal of Medicine Perspective,
Devices
An FDA briefing document released in advance of a 2/17 meeting of the Cardiovascular Devices Panel that will consider a PMA application submitted by Lutonix for its 014 drug-coated balloon PTA (percutaneous transluminal angioplasty) catheter says that limitations associated with the primary and supplementary data in the application
Devices
FDA and Defense Advanced Research Projects Agency staffers said at a recent Silicon Flatiron event that hardware security and trust must involve the integration of hardware and software protection strategies, as well as resilient build practices. FDA cybersecurity policy advisor Jessica Wilkerson said the growing integration of hardware and software
Devices
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Devices; Device Tracking — 21 CFR Part 821” (OMB Control Number 0910-0442). FDA regulations provide it the authority to require by order that a manufacturer adopt a method for tracking a Class 2 or 3 medical
Devices
FDA has granted BrainQ’s artificial intelligence (AI)-powered technology for ischemic strokes a breakthrough device designation based on the company’s latest randomized controlled clinical trial results. BrainQ says it is developing the AI-powered electromagnetic field therapy that aims to enhance recovery and reduce disability after neurological damage
Devices
FDA has classified as Class 1 a Boston Scientific recall of its Emblem S-ICD subcutaneous electrode because of an increased risk of fractures at the distal to the proximal sense ring. If the device fractures during use, it could become unable to deliver therapy to slow very fast heartbeats
Devices
FDA has cleared an Access Vascular 510(k) for its HydroMID midline catheter, which is made using the company’s proprietary biomaterial that it says has been shown to reduce thrombus accumulation by up to 97% when compared to standard polyurethane catheters. HydroMID is described as a 4 French, single
Devices
Only 10% of artificial intelligence (AI) products cleared by FDA for use in breast imaging provided a breakdown of racial demographics of the data used to validate the algorithm’s performance in public summaries filed by manufacturers. A Stat analysis says the remaining 90% only said that they have been
Devices
FDA has cleared an Acuitive Technologies 510(k) for its Citrefix Knotless Suture Anchor System with Citregen material technology, a bioresorbable synthetic polymer. The device is intended to assist tissue attachment to bone during orthopedic surgeries such as fixation of ligaments or tendon graft tissue repairs of the shoulder, elbow,
Devices
FDA has classified as Class 1 a recall of Smiths Medical Medfusion Syringe Pumps (Models 3500 and 4500) due to the risk of medication delivery errors related to a software error. The devices are intended to deliver blood, blood products, prescribed drugs, and other fluids into a patient’s body
Devices
Three senators are asking FDA to quickly conduct a review of the accuracy of pulse oximeters across racially diverse patients and consumers. A 1/25 letter to FDA acting commissioner Janet Woodcock from Sens. Elizabeth Warren (D-MA), Ron Wyden (D-OR), and Cory Booker (D-NJ) references a recent
Devices
CDRH Office of Surgical and Infection Control Devices biomedical engineer Devashish Shrivistava says FDA has enacted an enforcement policy for bioburden reduction systems using dry heat to support single user reuse of certain filtering facepiece respirators during the Covid-19 public health emergency “to help address the urgent public health
Devices
FDA has cleared an Ava 510(k) for its wearable Fertility Tracker to aid women in ovulation prediction and facilitating conception. To gain FDA clearance, Ava says it submitted multiple performance tests, including a prospective clinical trial demonstrating that the device accurately predicted the day of ovulation. “Results demonstrated that
Devices
FDA says it is monitoring clinical experience with ventilator splitters (multiplexing ventilator tubing connectors) in situations in which no alternatives for invasive ventilatory support are available. Splitters are intended to divide the gas flow from a single mechanical ventilator to deliver a tidal volume to more than one patient and
Devices
A new Medical Imaging & Technology Alliance (MITA) white paper, “Understanding Accountability in Medical Device Servicing,” calls on FDA to do more to hold third-party medical device servicing businesses accountable. The document gives an overview of the types of organizations and entities that perform medical device servicing and the
Drugs
A Hogan Lovells white paper, “The False Claims Act Guide: 2020 and the Road Ahead,” says that a federal directive to prioritize the investigation of coronavirus-related fraud, the unprecedented amount of federal stimulus payments, and the transition to a new administration are creating a climate in which False Claims
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CDRH Office of Neurological and Physical Medicine Devices director Carlos Pena has left the agency to develop the newly established Office of Regulatory Services at Jacobs Institute in Buffalo, NY. The institute says its mission is to “accelerate the development of next-generation technologies in vascular medicine through collisions of
Devices
FDA has granted Roche a breakthrough device designation for its Elecsys GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. The in vitro diagnostic immunoassay is intended to measure Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumors for
Devices
FDA has granted a Signifier Medical Technologies de novo request to permit the marketing of a new prescription-only device, eXciteOSA, intended to reduce snoring and mild obstructive sleep apnea. “Unlike devices used while patients sleep, this is the first device used while awake that is intended to improve tongue
Devices
FDA has cleared a Precision Spine 510(k) for its Dakota ACDF Standalone System for treating degenerative disc disease (DDD). The device features a titanium plate polyetheretherketone cage with cortical cancellous screws for maximum support and a generous cavity for autogenous bone graft to help facilitate fusion, the company says.
Devices
FDA has cleared a B-Secur 510(k) for its HeartKey software library, which was developed to enable scalability of medical grade EKG/ECG across “Internet of Things” devices. The company says its suite of powerful EKG/ECG algorithms combine user identification, health and wellness to generate accurate data encrypted