Abbott (NYSE:ABT) announced today that it received FDA breakthrough device designation for its deep brain stimulation (DBS) system. The breakthrough nod allows Abbott to investigate the use of its DBS system in treatment-resistant depression (TRD), a form of major depressive disorder (MDD). Abbott Park, Illinois-based Abbott designed its DBS system as a personalized, adjustable therapy […]
Implants
Ancora Heart’s AccuCinch ventricular restoration system wins FDA breakthrough nod
Ancora Heart announced today that it received FDA breakthrough device designation for its AccuCinch ventricular restoration system. Santa Clara, California-based Ancora Heart designed its AccuCinch system to provide a minimally invasive treatment option for patients who have symptomatic heart failure (HF) with reduced ejection fraction (HFrEF). The company is currently evaluating the system in the […]
Lyra Therapeutics appoints new chief medical officer
Lyra Therapeutics (Nasdaq:LYRA) announced today that it appointed Dr. Richard Nieman as its new chief medical officer (CMO). Nieman’s appointment as CMO of Lyra, which develops the XTreo — a platform for enabling precise, sustained and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues — will be made […]
Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home. A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year. Salt Lake […]
SpineX enrolls first patient in spinal neuromodulation technology trial
SpineX announced today that it enrolled the first patient in its pivotal trial evaluating the Scone neuromodulation device. Los Angeles-based SpineX will evaluate the safety and effectiveness of the non-invasive spinal neuromodulation technology for the treatment of neurogenic bladder. The first patient was enrolled at the Rancho Research Institute of the Rancho Los Amigos National […]
Bioventus restructures $315M CartiHeal acquisition
Bioventus (Nasdaq:BVS) amended the agreement for its pending acquisition of CartiHeal to defer a large chunk of payments. Durham, North Carolina-based Bioventus announced in April that it agreed to acquire the orthopedic implant maker in a deal worth at least $315 million. An amendment to the acquisition agreement reduces the closing payment to $50 million […]
3Spine wins FDA IDE for spine implant
3Spine announced today that it received FDA investigational device exemption (IDE) for its Motus spinal implant device. Chattanooga, Tennessee-based 3Spine designed the Motus device for use in the BalancedBack total joint replacement procedure. 3Spine’s BalancedBack procedure is indicated for the biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level […]
FDA grants breakthrough nod for Carthera’s SonoCloud-9
Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound […]
Onkos Surgical raises $26.5M
Surgical oncology device maker Onkos Surgical today filed an amendment to an SEC Form D confirming the sale of $26.5 million in equity. The equity offering had its first sale on Aug. 31, 2021 and today reached $26,500,001. That leaves no amount remaining to be sold. According to the amended SEC Form D, 16 investors […]
ZimVie launches duo of dental offerings
ZimVie (Nasdaq:ZIMV) announced today that it launched the T3 Pro tapered implant and Encode emergence healing abutment. Westminster, Colorado-based ZimVie designed the T3 Pro to deliver high primary stability and immediate function with a hybrid surface featuring its proprietary Osseotite surface on the implant collar, superimposed on the grit-blasted implant body. T3 Pro represents the […]
DJO parent Enovis unveils Arsenal ankle plating system
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 […]