Miach Orthopaedics announced today that the FDA cleared an expanded indication for the company’s Bear implant for ACL tears. The Bear implant previously won novo approval to treat skeletally mature patients at least 14 years of age with complete ACL tears. Now, the FDA granted 510(k) clearance to expand the indication to include children and […]
Pediatrics
Medtronic wins CE mark for jugular dual lumen catheter for young children
A Medtronic official said today on LinkedIn that the company won CE mark for its Crescent RA jugular dual lumen catheter. Giuseppe Savoja, the medtech giant’s senior business director for Western Europe, posted the announcement on LinkedIn: “Exciting times! I’m proud and thrilled to announce that the Medtronic Crescent RA jugular dual lumen catheter is […]
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 […]
Medtronic gets CE mark for Harmony transcatheter pulmonary valve
Medtronic today announced CE mark approval for its Harmony transcatheter pulmonary valve (TPV) system. About 1.3 children around the world each year are born with congenital heart disease, according to the Minneapolis-based nonprofit Children’s HeartLink. The Harmony system provides a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically […]
Align Technology wins CE mark for Invisalign palatal expander
Align Technology (Nasdaq:ALGN) announced today that it received CE mark for its Invisalign palatal expander system. In addition to CE mark under MDR, the palatal expander completed registration with MHRA for the UK and overseas territories. Approvals cover broad patient applicability, including growing children, teens and adults (with surgery or other techniques). The direct 3D-printed […]
BrightHeart earns FDA clearance for AI-powered prenatal heart ultrasound tech
BrightHeart announced today that it received FDA 510(k) clearance for its first AI software for prenatal ultrasound evaluations of the fetal heart. Paris-based BrightHeart designed its AI to address the challenges of detecting congenital heart defects (CHDs) in newborns. The company says misdetection or delayed diagnosis often leads to severe consequences, including missed opportunities for […]
FundamentalVR, AAO launch VR education for pediatric ophthalmic care
The American Academy of Ophthalmology (AAO), in partnership with FundamentalVR, today launched a new VR education program. This initiative aims to harness the power of VR to transform ophthalmic education and surgical training. Supported by a $5 million grant from the Knights Templar Eye Foundation, the platform offers a free and open simulation platform for […]
Renata Medical wins FDA nod for first-of-its-kind stent for young children
Renata Medical today said the FDA approved its first-of-its-kind Minima growth stent tailored for neonates, infants and young children. Newport Beach, California-based Renata designed the stent to re-expand over the course of the child’s growth period. The company says its approval marks a “groundbreaking advancement” in care for young children with congenital heart defects. Renata […]
FDA labels Ethicon recall of some Megadyne electrodes Class I
After Megadyne discontinued its pediatric patient return electrodes, the FDA labeled a recall of the electrodes Class I, the most serious kind. Megadyne removed the product last month after reports of patient burn injuries in procedures that used the electrodes. A root cause investigation included testing that showed a combination of factors that, when present […]
Megadyne discontinues pediatric patient return electrodes after recall woes
The FDA today said that Megadyne initiated a voluntary recall of its Mega Soft pediatric patient return electrodes, discontinuing the product. Megadyne removed the product after reports of patient burn injuries in procedures that used the electrodes. A root cause investigation included testing that showed a combination of factors that, when present together, may result in […]
