Devices
A CDRH 7/27 Webinar helped to clarify FDA’s current thinking on the distinction between medical device servicing and remanufacturing as discussed in a recent draft guidance. It also outlined specific cybersecurity challenges and opportunities associated with medical device servicing. During the Webinar staff from the CDRH Office of
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FDA has givern 510(k) clearance to LifeSignals Group for its LifeSignals ECG remote monitoring patch platform, a wireless system used by healthcare professionals for the continuous collection of electrocardiography and heart rate monitoring in ambulatory, hospital, home, and healthcare settings. The company says healthcare professionals can remotely access patient
Devices
FDA has granted Evren Technologies a breakthrough device designation for its Phoenix earbud device and its use in treating post-traumatic stress disorder. The device is intended to provide transcutaneous auricular vagal nerve stimulation in a proprietary closed-loop system. To obtain the designaion, the company says it provided preliminary
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FDA has classified as Class 1 a Philips Respironics recall of its continuous and non-continuous ventilators due to concerns about the polyester-based polyurethane sound abatement foam, which is used to reduce sound and vibration. A recall notice says the foam may break down and potentially enter the device’
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Regulatory flexibility and developer engagement are two lasting lessons that CDRH has to learn from the Covid-19 emergency, according to director Jeff Shuren. Speaking at an Alliance for a Stronger FDA update 7/22, Shuren said that "these two together were really the drivers of our ability to
Devices
Vero Biotech is recalling its Genosyl DS; Nitric Oxide Delivery System due to a software issue that leads to errors in gas delivery. “Typically, this issue caused delivery of lower-than-expected dosage of nitric oxide during the transition between primary and backup console,” a recall notice says. “If this
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FDA acting commissioner Janet Woodcock says part of the agency’s FY 2022 budget request is for $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program in CDRH. Writing in an FDA Voices online post, Woodcock says the funding “will provide, for the first time, resources
Devices
FDA has granted AnchorDx a breakthrough device designation for UriFind, an early detection test for bladder cancer based on urine DNA methylation detection. The test is intended as an alternative to traditional cystoscopy. It is designed to detect bladder cancer through random urine collection and conducting methylation detection of exfoliated
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Mintz attorneys say an FDA draft remanufacturing guidance issued 7/24 may be a step in the right direction to help entities identify when they are performing remanufacturing activities and thus subject to agency regulation, but does not provide a clear process for such determinations. The analysis says a flowchart
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FDA has cleared a Zoll Medical 510(k) for its TBI Dashboard feature on its Propaq M monitor and Propaq MD monitor/defibrillator. The dashboard provides clinical decision support for managing patients with traumatic brain injury, and was previously available on Propaq devices sold in international markets. The device is
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An online Evaluate Vantage post says FDA awarded just 12 first-time PMAs and one HDE during the first six months of this year. The post says that if the agency maintains the same approval rate in the second half of the year, it will see the fewest high-risk
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FDA has cleared a First Light Diagnostics 510(k) for its SensiTox C. difficile toxin test along with its proprietary MultiPath Analyzer. C.difficile causes more life-threatening hospital infections than any other pathogen and is considered by the CDC to be an urgent antibiotic resistance threat, according to the
Devices
FDA has granted NeuroMetrix a breakthrough designation for its Quell device and its use in treating the symptoms of fibromyalgia in adults. Quell is a wearable nerve stimulation device that provides nerve stimulation to treat fibromyalgia-related pain. The designation was based on data from a double-blind, randomized, sham-
Devices
FDA has granted Endologix a breakthrough device designation for its ChEVAS (Chimney EndoVascular Aneurysm Sealing) System, an endovascular abdominal aortic aneurysm (AAA) sealing therapy. The device is designed to combine the company’s Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxtarenal, pararenal and
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FDA has approved a Nevro Corp. PMA for its Senza System for treating chronic pain associated with painful diabetic neuropathy. The approval is specific to Nevro’s unique 10 kHz stimulation, the company says. Approval was based on data showing that study participants demonstrated significantly improved and sustained outcomes with
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KorvaLabs has requested that its emergency use authorization for the Curative SARS-Cov-2 (Covid-19) test be revoked because it is now using different EUA-authorized tests for the testing offered at its laboratories. The Curative test was the subject of a January FDA safety alert about false result
Devices
FDA has cleared a Dexcom 510(k) for its Dexcom Partner Web application programming interface (API) to enable invited third-party developers to integrate real-time continuous glucose monitoring data into their digital health apps and devices. “Several prominent diabetes and digital health companies have been invited to access the
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Members of the FDA Gastroenterology and Urology Devices Panel voted 12-1-1 on 7/14 that the benefits of the TransMedics OCS (organ care system) liver preservation system outweigh its risks. Votes on the device’s safety and effectiveness were unanimously supportive, MedTechDive reports. The online report says the
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FDA has granted iStar Medical an IDE to begin a pivotal trial with its Miniject implant in over 350 patients with primary open angle glaucoma. The STAR-V trial will evaluate the device’s efficacy by the mean reduction in eye pressure, as well as the proportion of patients achieving
Devices
FDA has cleared a Palliare 510(k) for the END-200 tubeset that expands the use of its EVA15 continuous pressure insufflation technology from laparoscopic surgery to endoscopic and endoluminal surgery. The EVA15 insufflator and smoke evacuation system is designed to create a safer operating room environment and deliver insufflation
Devices
FDA says patients, caregivers, and healthcare providers should be aware of potential mechanical failures and concerns about tissue incompatibility associated with components of several specified NuVasive Specialized Orthopedics MAGEC devices. An agency safety communication refers to a company 2/2020 notice recalling its MAGEC devices to address a mechanical component
Devices
FDA has cleared an EnsoData 510(k) for new capabilities and enhancements to its EnsoSleep product, an artificial intelligence-assisted sleep scoring program that automates event detection in polysomnography (PSG) and home sleep apnea tests (HSAT). “Our enhancements to EnsoSleep will help to further expand patient access to quality care