Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes initiated a select recall of power tool system battery adaptors due to possible explosion risks, according to an FDA notice posted today. The federal watchdog labeled the recall as a Class I, the most serious type of recall issued, indicating “a reasonable probability that use of these products will cause […]
Food & Drug Administration (FDA)
Becton Dickinson wins 510(k) for Vacutainer Barricor tubes
Becton Dickinson & Co. (NYSE:BDX) said today it won FDA 510(k) clearance for its Vacutainer Barricor plasma blood collection tube. The Franklin Lakes, N.J.-based company touted improvements to the next-gen blood collection and separation device, saying its designed to improve sample quality, speed up result returns and improve patient care and clinical efficiency. “As we launch […]
FDA approves Medtronic’s ‘artificial pancreas’ MinMed 670G hybrid closed loop system
The FDA today granted premarket approval to Medtronic (NYSE:MDT) for its MiniMed 670G ‘artificial pancreas’ hybrid closed loop system, making it the 1st system of its kind to win clearance globally. The MiniMed 670G is designed to automatically track and adjust blood sugar levels in patients with diabetes, measuring blood glucose every 5 minutes and automatically administering […]
Abbott wins FDA nod for Freestyle Libre Pro
Abbott (NYSE:ABT) said today it won FDA premarket approval for the FreeStyle Libre Pro continuous glucose monitoring system designed for use by healthcare professionals to treat patients with diabetes. The FreeStyle Libre Pro professional use device uses a patient-worn sensor to track blood glucose levels for up to 14 days. The sensor is applied by a […]
Medtronic wins FDA nods for TrailBlazer peripheral support cath
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its TrailBlazer angled support catheter designed for use in the peripheral vascular system. The Fridley, Minn.-based company’s newly cleared TrailBlazer cath is designed to support a guide wire during peripheral artery access to enable the delivery of solutions and diagnostic agents. Support catheters, such as […]
BrainScope wins FDA nod for Ahead 300 TBI scanner
Brainscope said today that it won FDA 510(k) clearance for its next-gen Ahead 300 traumatic brain injury assessment device, developed through a partnership with the U.S. Defense Dept. The Bethesda, Md.-based company’s Ahead 300 is designed to provide multiple clinically relevant measures for assessing traumatic brain injury, including concussions. The new version will also be the […]
Allergan wins FDA nod for Natrelle Inspira breast implants
Allergan (NYSE: AGN) said last week that it won FDA pre-market approval for its Natrelle Inspira cohesive breast implants for women undergoing breast reconstruction, augmentation or revision surgery. The newly cleared Natrelle Inspira implants combine both a high gel fill ratio and the company’s cohesive gel to create a customized shape, the company said. “Natrelle […]
FDA OKs Regentis Biomaterials trial for GelrinC knee cartilage treatment
Regentis Biomaterials said today it won an investigational device exemption from the FDA for a pivotal trial of its GelrinC hydrogel-based resorbable treatment for focal cartilage defects in the knee. The Phase III study aims to evaluate the safety and efficacy of GelrinC compared to microfracture treatment to support pre-market approval for focal defects, which normally occur […]
FDA clears Medtronic’s StealthStation DBS lead placement software
Medtronic (NYSE:MDT) said today that the FDA granted 510(k) clearance for its StealthStation software, which is designed to help plan the placement of the leads used for deep-brain stimulation therapy. Fridley, Minn.-based Medtronic said StealthStation is designed to work with its O-arm imaging system to integrate pre-operative planning and intraoperative imaging during DBS device implantations. “The […]
FDA relabels RebiScan pediatric vision scanner as Class II device
The FDA today said it reclassified RebiScan’s handheld pediatric vision scanner device as a Class II device. RebiScan’s flagship PVS won FDA de novo clearance in June, with indications for screening young children for amblyopia and strabismus. Boston-based RebiScan put in a request to classify the device as Class II in December 2013, according to the FDA. […]
Parent bloggers question Mylan’s EpiPen school campaign
Three years ago, Mylan (NSDQ:MYL) began holding summits for food allergy bloggers to learn about its campaign to get its EpiPen epinephrine injector into schools. Many of the bloggers, mothers of children with serious allergies, were eager to help. Some, including Ruth LovettSmith, wrote thousands of posts, providing testimony that some legislators say convinced them […]