Enovis, the parent company of DJO, announced today that it launched its Arsenal ankle plating system. The Arsenal ankle plating system — the latest addition to the Enovis suite of foot and ankle products and an expansion of the Arsenal foot plating system, consists of 37 anatomically designed plates throughout nine plate families to accommodate […]
Implants
Conmed completes $145M In2Bones acquisition
Conmed (NYSE:CNMD) announced today that it completed its previously announced acquisition of In2Bones Global. Largo, Florida–based Conmed announced last month that it intended to acquire upper extremities device maker In2Bones Global for $145 million. The $145 million figure was floated for the closing of the acquisition, with up to an additional $110 million in growth-based […]
Si-Bone wins FDA clearance for expanded iFuse-TORQ implant indication
Si-Bone announced today that the FDA granted clearance for its iFuse-TORQ implant for pelvic fracture fixation. The regulatory nod expands Si-Bone’s iFuse-TORQ’s indication for acute, non-acute and non-traumatic pelvic fractures, including pelvic fragility fractures (fractures related to low-energy traumatic events) and pelvic insufficiency fractures. Santa Clara, California-based Si-Bone said in a news release that the […]
FDA clears lumbar interbody fusion device from Zavation Medical
Zavation Medical announced today that it received FDA 510(k) clearance for its eZspand lateral expandable lumbar interbody fusion device. Flowood, Mississippi-based Zavation designed the eZspand lateral, part of the Zavation eZspand interbody system, with precision and continual expansion to offer an optimized fit for each patient, allowing for the enhancement of structural stability and improved […]
FDA designates new Medtronic HVAD pump implant recall as Class I
Medtronic (NYSE:MDT) is recalling 1,614 of its HeartWare Ventricular Assist Device (HVAD) pump implant kits due to defective welds connected to at least one death. The Class I recall — the most serious type of FDA recall, in which use of the device may cause serious injuries or death — is the latest of more than 15 […]
Abbott presents positive data on MitraClip, TriClip heart implants
Abbott (NYSE:ABT) today announced late-breaking data supporting its MitraClip and TriClip structural heart solutions. Data for the MitraClip transcatheter edge-to-edge repair (TEER) device and the TriClip minimally invasive tricuspid heart valve repair device were presented at TVT: The Structural Heart Summit, the annual meeting from the Cardiovascular Research Foundation in Chicago. The company said in […]
Ocular Therapeutix adds two executives to leadership team
Ocular Therapeutix (Nasdaq:OCUL) announced today that it made two additions to its executive leadership team. Bedford, Massachusetts-based Ocular Therapeutix appointed a chief medical advisor (CMA) — a newly created role — as well as a new chief medical officer (CMO). Additionally, the company created a new role called chief strategy advisor (CSA) for its departing […]
How fluorescent signals could allow for deeper sensor implants in the brain
Engineers at the Massachusetts Institute of Technology have developed a photonic technique for fluorescent sensors that could improve sensor signals deep in the body. Fluorescent sensors are typically used to label and image a variety of molecules to give a unique glimpse inside living cells. However, the method has been limited to cells grown in […]
InVivo Therapeutics completes enrollment in study of Nuero-Spinal Scaffold
InVivo Therapeutics (Nasdaq:NVIV) announced today that it completed enrollment in the Inspire 2.0 study for patients with acute spinal cord injury. Cambridge, Massachusetts–based InVivo’s 20-patient randomized, controlled trial aims to enhance the clinical evidence for the company’s Neuro-Spinal Scaffold. The company designed the Neuro-Spinal Scaffold to encourage functional cells to fill a cavity that will […]
Axonics files FDA PMA supplement for 4th-gen rechargeable neurostimulator
Axonics (Nasdaq:AXNX) announced that it filed a premarket approval (PMA) supplement with the FDA for its next-generation neurostimulator. Irvine, California–based Axonics designed its fourth-generation rechargeable sacral neuromodulation implantable neurostimulator (INS) to reduce the frequency with which a patient needs to recharge their implanted device to just once every six months for one hour. The current […]
Si-Bone wins FDA clearance for pelvic fixation, fusion tech
Si-Bone announced today that it received FDA 510(k) clearance for its iFuse Bedrock Granite implant system for spinal procedures. Santa Clara, California-based Si-Bone designed the iFuse “Granite” implant to provide sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion. According to a news release, FDA clearance follows earlier breakthrough device designation […]