Devices
FDA has cleared a Cleveland Clinic 510(k) for patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea. The devices are used to keep airways open in patients with serious breathing disorders, such as those caused by tumors, inflammation, or trauma. Previously, the patient-specific devices were being
Devices
Attorneys Jeffrey Gibbs and McKenzie Cato (Hyman, Phelps & McNamara) document the slow disappearance of advisory panel meetings for PMA applications. Writing in their firm’s FDA Law Blog, the two say there were nine panel meetings in 2010, two in 2019, and none last year. They say the panel
Devices
FDA has accepted for review a Neovasc PMA for its Neovasc Reducer for treating refractory angina. The device is intended to relieve angina symptoms by altering blood flow within the heart’s myocardium and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle, the company says.
Drugs
Attorneys from McDermitt Will & Emery say that in 2019 the CDER Office of Prescription Drug Promotion (OPDP) issued a total of six untitled letters and three Warning Letters, a slight increase over the 2018 total. Writing in their firm’s review of the year 2019 for FDA, they say
Devices
CDRH associate director for compliance and quality Erin Keith says the number of Warning Letters issued by the Center may start to climb this year as reorganization bugs that prevented sending letters on time are worked out. However, not all observers agree that reorganization is the only cause for a
Devices
FDA has cleared a BioCardia 510(k) for the Morph DNA deflectable guide catheter used to guide the Helix Biotherapeutic Delivery System during CardiAMP cell therapy delivery in the heart. The guide catheter is designed to improve procedural control of therapeutic catheters, such as the Helix system, during delivery of
Devices
A new CDRH Learn Webcast module, “Production and Process Controls, Part 2: Acceptance Activities, Handling, Storage, Distribution, and Installation,” reviews the purpose of the production and process controls subsystem and describes aspects of acceptance activities, handling, storage, distribution, and installation. Presented by CDRH Division of Industry and Consumer Education consumer
Devices
FDA has granted ArcherDX a breakthrough device designation for its Personalized Cancer Monitoring technology for early-stage cancer treatment monitoring and recurrence surveillance. The device is intended to enable healthcare providers across community and academic care settings access to genomic information in their laboratory. The company says that fewer than
Devices
FDA has cleared an Aidoc 510(k) for its artificial intelligence (AI) component for flagging large-vessel occlusion in head computed tomography angiography scans. The latest AI module joins a previous cleared module for flagging and prioritizing intracranial hemorrhage to provide a comprehensive AI package for identifying and triaging both
Devices
Galemed has recalled (Class 1) its Babi.Plus Pressure Relief Manifold system due to complaints about the device not holding pressure when initially set up on a patient. This malfunction is traced to a dislodged valve not being properly seated, resulting in loss of pressure in the system, a recall
Devices
FDA has released a draft guidance on “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions.” The document provides draft recommendations, including bench testing and coating characterizations for 510(k) submissions for PTA balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-
Devices
A year after Bayer stopped selling and distributing Essure, an implantable contraceptive device, CDRH director Jeff Shuren says the company has repossessed 99% of unused devices in the market. “Additionally, postmarket safety monitoring for women who have Essure implanted remains a top priority for the agency, and today we are
Devices
FDA has granted Reflow Medical a breakthrough device designation for the Temporary Spur Stent System, a novel retrievable stent technology intended for treating below-the-knee (BTK) peripheral artery disease. The combination device comprises a “patented retrievable stent system having a series of radially expandable spikes designed to create multiple
Devices
FDA has approved a MicroVention PMA for the FRED (Flow Re-Direction Endoluminal Device) device for treating brain aneurysms. The company says this is the first flow diverter in the U.S. to use a self-expanding braided nitinol mesh to help re-direct blood flow and promote aneurysm occlusion.
Drugs
The Coalition to Preserve Access to Pharmacogenomics (PGx) Information has petitioned FDA urging it to stop enforcement actions against genetic tests that claim to predict a patient’s response to specific medications. Over the past year, the agency has warned several companies about claims made for specific genetic tests. It
Devices
CDRH scientists and engineers have developed a new tool to help hospitals determine how clean an endoscope is after it has been reprocessed. The effort is being led by the Center’s Biofilms Research Group and the Office of Science and Engineering Laboratories. Studies at hospitals are underway to confirm
Devices
FDA has cleared a Penumbra 510(k) for an expanded indication for its Indigo Aspiration System — treating pulmonary embolisms. Previously, the device was cleared for removing fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The company says it uses its proprietary Penumbra Engine aspiration
Devices
FDA has granted 3Derm Systems a breakthrough device designation for its 3DermSpot, an algorithm that uses artificial intelligence (AI) and highly standardized skin images to autonomously detect melanoma, squamous cell carcinoma, and basal cell carcinoma. If approved by FDA, the device will be the first to bring dermatologist-level triage
Devices
Minneapolis Heart Institute researchers say that FDA and the medical device industry need to improve the way they manage medical device recalls. Writing in JAMA Internal Medicine, the researchers say that their study of patients implanted with a defective Medtronic InSync pacemaker showed that the pacemaker recall was delayed and
Devices
FDA says it has contracted with Dun & Bradstreet to conduct onsite verification of medical device facility information provided to the agency by registered and listed medical device manufacturers. An agency notice says that participation is voluntary and FDA asks that if a company is contacted by Dun & Bradstreet
Devices
FDA has cleared an IceCure Medical 510(k) for its Cryoablation Technology and its use to destroy benign and cancerous tumors by freezing them. The device is cleared for treating tumors of the kidney, liver, ear, nose throat and certain neurology areas. Additionally, the clearance also covers the company’s
Devices
FDA has approved Abbott’s new alternative surgical technique for its HeartMate 3 heart pump that will allow more advanced heart failure patients to avoid open heart surgery. Historically, heart pumps have been implanted through open heart surgery, the company says. With approval for an alternative surgical technique, Abbott’s