Months into the pandemic, the FDA continues to grant emergency use approval (EUA) to new tests to detect the virus that causes COVID-19 and the antibodies that indicate a person has had it. To date, the FDA has granted EUAs for 171 tests —142 molecular tests, 27 antibody tests, and 2 antigen tests. Given the ever-changing […]
US FDA extends UDI deadlines for low-risk medical devices
By Stewart Eisenhart, Emergo Group Final guidance from the US Food and Drug Administration pushes back enforcement deadlines for certain Unique Device Identification (UDI) requirements for Class I and unclassified medical devices due partially to the agency’s coronavirus pandemic-related priorities. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
FDA plans to resume onsite inspections later this month
FDA has a goal of restarting on-site inspections during the week of July 20 — four months after it temporarily halted them — though there will be changes due to the COVID-19 pandemic. The agency today said that it will pre-announce inspections to FDA-regulated businesses. Said FDA: “This will help assure the safety of the […]
FDA clears Infervision’s lung CT.AI system
Infervision announced that it received FDA 501(k) clearance for its InferRead Lung CT.AI system which uses AI to automatically perform lung segmentation. InferRead Lung CT.AI is designed to use AI and deep learning technology to support concurrent reading and aid radiologists in pulmonary nodule detection during the review of chest CT scans, increasing accuracy and […]
FDA clears new Baxter bone graft substitute
Baxter (NYSE:BAX) announced today that it received FDA clearance for its Altapore Shape bioactive bone graft for bone growth and fusion. Deerfield, Ill.-based Baxter’s Altapore Shape is its latest addition to its bone graft substitute product line, designed to enhance bone growth and aid in achieving fusion, leading to reduced pain and other improved clinical outcomes […]
Essure study shows more pain, bleeding in women with implant
Interim results from a postmarket study of the Bayer (ETR:BAYN) Essure permanent birth control device revealed higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared with laparoscopic tubal ligation as permanent birth control. The FDA posted the results as part of a long-term safety evaluation of the device, which has […]
Soterix wins IDE for depression treatment trial
Soterix Medical announced today that it received FDA investigational device exemption (IDE) to launch a trial of its tDCS-LTE) neuromodulation system. New York-based Soterix Medical’s transcranial direct current stimulation-limited total energy (tDCS-LTE) system is an at-home platform for people suffering from major depressive disorder (MDD). The proprietary technology is designed to support the home-based tDCS, […]
Dascena wins FDA beakthrough device designation for AI to predict kidney injury
Dascena announced today that it received FDA breakthrough device designation for its Previse algorithm for predicting acute kidney injury (AKI). The artificial intelligence (AI)-based algorithm is designed to predict AKI more than a full day before patients meet the clinical criteria for diagnosis. The company touts its regulatory victory as the first breakthrough nod for […]
FDA warns of false positives with certain COVID-19 tests from BD
The FDA issued a statement today warning on an increased risk of false positive results with the BD Max System SARS-CoV-2 tests from Becton Dickinson (NYSE:BDX). The agency is alerting clinical laboratory staff and healthcare providers to the risk after a study in which the manufacturer found that approximately 3% of results from the BD SARS-CoV-2 […]
Abbott wins FDA approval for Bluetooth heart rhythm devices
Abbott (NYSE:ABT) announced today that it received FDA clearance for its next-generation Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The next-generation devices offer a patient-preferred design with Bluetooth technology and a new patient smartphone app while sidestepping any compromise of battery longevity and MRI compatibility, according to a news release. Gallant, which […]
FDA approves Cochlear sound processor
Cochlear Ltd. (ASX:COH) announced today that it received FDA approval for three new products in its suite of implantable hearing technology. Lone Tree, Colo.-based Cochlear won approval for its Nucleus Kanso 2 sound processor, Nucleus 7 sound processor for Nucleus 22 implant recipients and Custom Sound Pro fitting software, according to a news release. Cochlear touts […]
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