The FDA today issued a notice informing customers of updated instructions for the Johnson & Johnson MedTech Abiomed Impella RP heart pump. Impella RP offers up to 14 days of use in patients who develop acute right heart failure after left ventricular assist device (LVAD) implantation. Placed in the internal jugular vein, it supports the […]
Food & Drug Administration (FDA)
Outset Medical resolves FDA warning letter
Outset Medical announced today that the FDA says it addressed all issues cited in a 2023 warning letter. Shares of OM rose nearly 4% to 85¢ apiece after hours shortly after the company made its announcement. In July 2023, the company announced that it received a warning letter from the FDA related to its Tablo […]
Neuvotion wins FDA nod for neuromod wearable
Neuvotion announced today that it received FDA 510(k) clearance for its first product, the NeuStim wearable device. The company designed NeuStim to electrically stimulate muscles dynamically and with high precision. It supports hand movement recovery after stroke or spinal cord injury (SCI). The system enables clinicians to quickly scan and pinpoint stimulation targets through an […]
BD warns on atherectomy catheters after deaths
BD recently issued a medical device correction later related to its Bard subsidiary’s Rotarex atherectomy system. The company identified a number of anatomical factors that could contribute to catheter helix fracture and/or breakage. It reports 30 serious injuries and four deaths associated with the issue. Additionally, BD reported 115 cases requiring additional intervention following helix […]
Medline has a Class I arterial catheter recall
The FDA labeled a recall of integrated arterial catheters made by Medline Class I, the most serious kind of recall. This recall involves removing certain devices from where they are used or sold. The company reports no injuries or deaths related to this recall to date, according to an FDA notice. Medline designed its arterial […]
FDA warns of potential missed alerts with smartphone-connected diabetes devices
The FDA today issued a safety communication relating to certain diabetes devices that connect to smartphones. Our sister site, Drug Delivery Business News, reports today that the FDA received medical device reports in which users reported failed delivery of alerts or failure to hear alerts from their smartphones that connect to diabetes devices. In these cases, […]
Newronika wins FDA IDE for adaptive deep brain stim tech
Newronika announced today that it received FDA investigational device exemption (IDE) for its deep brain stimulation (DBS) system. The IDE enables Newronika to initiate a pivotal U.S. clinical trial to evaluate the safety and efficacy of the adaptive DBS system. It could aid patients with movement disorders, including Parkinson’s disease. Milan, Italy-based Newronika said it […]
FDA clears AI 3D head, neck imaging tech from RapidAI
RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution. San Mateo, California-based RapidAI designed its platform to replace manual workflows with an AI-powered approach. The company says manual computed tomography angiography (CTA) reconstructions take considerable time, with turnaround stretched to hours at times. This can delay critical […]
FDA clears Instylla’s Tembo Embolic System
Instylla today said it has won FDA 510(k) clearance for its Tembo Embolic System. Bedford, Massachusetts-based Instylla said the Tembo system is a bioresorbable embolization agent with particles designed for embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature. Those irregularly shaped, dry gelatin particles range in size between 85 […]
FDA selects a CDRH official as acting commissioner
Dr. Sara Brenner, who has been FDA CDRH’s in vitro diagnostics chief medical officer, is serving as acting commissioner of the agency. That’s according to a recent update to the agency’s leadership profiles. The FDA, which has been under a communications freeze under the new Trump administration, did not immediately respond to MassDevice requests for […]
Imperative Care wins FDA clearance for Zoom stroke treatment
Imperative Care announced today that it has secured FDA 510(k) clearance for its Zoom comprehensive stroke thrombectomy system. According to Campbell, California–based Imperative Care, the Zoom system is the first such system to include large-bore .088-in. catheters indicated for both access and aspiration when used with one of the company’s Zoom catheters. The FDA clearance […]
