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 […]
FDA
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 adds RevMedica stapling platform to STeP program
RevMedica announced that the FDA accepted its Endo stapling platform into its Safer Technologies Program (STeP). STeP, a collaborative program, helps reduce the time needed to develop and obtain marketing authorization for eligible devices. The FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program. The program covers devices that could improve […]
FDA clears Nalu peripheral nerve stim tech for whole-body MRI
Nalu Medical announced today that the FDA cleared expanded labeling of its peripheral nerve system to include whole-body MRI use. The clearance gives physicians greater flexibility in treating chronic pain, minimizing MRI-related limitations with whole-body MRI-conditional use. Nalu’s system now enables personalized care without compromising future diagnostic imaging needs. Carlsbad, California–based Nalu offers FDA-cleared spinal […]
CergenX wins FDA breakthrough nod for neonatal brain monitoring tech
CergenX announced today that the FDA granted breakthrough device designation for its Wave device for neonatal brain monitoring. Additionally, the FDA accepted the Cork, Ireland-based company into its Total Product Lifecycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access […]
FDA clears CapsoVision capsule endoscopy tech for pediatric patients
CapsoVision announced today that the FDA cleared its CapsoCam Plus system for use in pediatric patients aged two and above. The CapsoCam Plus system delivers a non-invasive, comfortable endoscopy in the form of a capsule device. Saratoga, California-based CapsoVision designed its system with four cameras. It delivers a 360° panoramic lateral view of the small […]
AccurKardia wins FDA breakthrough nod for hyperkalemia detection software
AccurKardia announced today that it received FDA breakthrough device designation for its ECG-based, AI-powered hyperkalemia detection software. The AK+ Guard software uses Lead I ECG data to alert patients and clinicians of moderate to severe episodes of hyperkalemia. These episodes of excess potassium in the blood can lead to sudden cardiac arrest, according to a […]
