The FDA announced today that it approved the MicroTransponder Vivistim paired VNS system for chronic ischemic stroke rehabilitation. MicroTransponder designed its Vivistim System as a first-of-its-kind, drug-free rehabilitation system for treating moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation, according to an FDA news release. Vivistim electrically […]
Implants
How Medtronic fit a battery into a tiny pacemaker
Medtronic’s Micra pacemakers are one-tenth the size of what was previously out there. How the medtech giant did it provides lessons for anyone looking to shrink an implantable device. It was an all-hands-on-deck effort that consumed Medtronic in the early 2010s: the in-house creation of a pacemaker small enough to go inside the heart via […]
DePuy Synthes launches Inhance shoulder system
Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes this week announced that it has launched its Inhance shoulder system. DePuy Synthes designed the Inhance system as a fully integrated shoulder arthroplasty system. It has an intuitive stemless-first surgical approach that offers surgeons the ability to seamlessly transition from stemless to stemmed implants during surgical procedures, according to the […]
Medtronic to acquire Intersect ENT in $1.1B deal
Medtronic (NYSE:MDT) today announced that it has entered a definitive agreement to acquire Intersect ENT (NSDQ:XENT) for $1.1 billion. Medtronic will acquire all outstanding shares of the Menlo Park, Calif.-based sinus implant maker for $28.25 per share in an all-cash transaction. The deal is expected to close toward the end of Medtronic’s 2021–22 fiscal year, subject to […]
Abbott CMO Dr. Nick West touts latest iteration of drug-eluting stent
Abbott executive Dr. Nick West believes the company offers the “best-in-class” drug-eluting stent with its Xience platform. When Abbott (NYSE:ABT) CMO & divisional VP of global medical affairs for its vascular business Dr. Nick West looks back at his use of drug-eluting stents in the early 2000s, all he sees now is innovation. As a practicing interventional cardiologist, West […]
FDA clears Medtronic’s AI algorithms for cardiac monitoring
Medtronic (NYSE:MDT) announced today that the FDA cleared two of its AccuRhythm AI algorithms for use with the Linq II ICM. Fridley, Minn.–based Medtronic’s AccuRhythm AI applies artificial intelligence to heart rhythm event data collected by the Linq II insertable cardiac monitor (ICM) to improve the information provided to physicians for better diagnoses and treatments […]
Intersect ENT launches VenSure balloon sinus dilation system in U.S.
Intersect ENT (NSDQ:XENT) today announced that it has commercially launched its VenSure balloon sinus dilation system and Cube 4D navigation system in the U.S. Menlo Park, Calif.-based Intersect ENT designed the VenSure balloon and Cube 4D navigation system to be used in procedures that improve debilitating chronic rhinosinusitis (CRS) symptoms. Cube 4D has VirtuEye photo registration […]
Blackrock Neurotech and ClearPoint Neuro want to automate brain implant surgeries
ClearPoint Neuro (NSDQ:CLPT) announced an agreement with Blackrock Neurotech to develop automated technologies for brain implant surgeries. The partnership will seek to develop an automated surgical solution for implanting brain-computer interfaces (BCIs) into patients with neurological disorders including from paralysis, ALS, blindness and hearing loss, among others. Get the full story at our sister site, […]
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
FDA raises concerns about NuVasive Magec devices
The FDA today issued a notice warning patients, caregivers and healthcare providers of potential issues with Magec devices from NuVasive (NSDQ:NUVA). NuVasive’s Magec, a growing spinal rod system intended for use in children under 10, uses magnets to help correct spinal deformities as the child grows. The company designed Magec to help avoid multiple operations while […]
FDA grants iStar Medical IDE for glaucoma implant pivotal trial
iSTAR Medical announced today that the FDA granted investigational device exemption to start a pivotal trial with its MINIject implant. Wavre, Belgium–based iStar’s MINIject minimally invasive implant for glaucoma surgery will be investigated in the STAR-V study, which will enroll over 350 patients with primary open-angle glaucoma. Get the full story at our sister site, Drug […]