Nyxoah announced today that it sold 3 million shares to raise $27 million in gross proceeds to support its sleep apnea therapy. Mont-Saint-Guibert, Belgium–based Nyxoah develops neuromodulation technology to treat obstructive sleep apnea (OSA). This market — led by Inspire Medical with companies like LivaNova and XII Medical vying for share — could offer an […]
Implants
4C Medical commences enrollment in heart valve trial
4C Medical Technologies announced today that it commenced enrollment in its ATLAS pivotal trial evaluating its AltaValve system. ATLAS (a transseptal left atrial system for the treatment of mitral regurgitation, or MR) evaluates AltaValve’s safety and efficacy. Participants in the study have moderate-to-severe or severe MR and are unsuitable for surgery or transcatheter edge-to-edge repair […]
Precision Neuroscience has more positive BCI data
Precision Neuroscience today announced the presentation of results from a pilot study of its brain-computer interface (BCI) technology. Researchers from the lab of Dr. Iahn Cajigas presented results at the Society for Neuroscience (SfN) Neuroscience 2024 conference in Chicago. Cajigas serves as a neurosurgeon at Penn Medicine and an assistant professor of neurosurgery and bioengineering […]
Medinol has first human implant of drug-eluting peripheral stent in Australia
Medinol today announced the successful first-in-human implantation of its ChampioNIR drug-eluting peripheral stent. Dr. Gerard S. Goh and Dr. Thodur Vasudevan of the Alfred Hospital in Melbourne, Australia, completed the stent implant. The company says it introduces a “revolutionary advancement” in the mechanics, durability and drug delivery of peripheral drug-eluting stents. Tel Aviv, Israel-based Medinol […]
InspireMD wins FDA IDE for carotid stent study
InspireMD (Nasdaq:NSPR) announced today that the FDA granted investigational device exemption (IDE) for its CGuard Prime 80cm carotid stent system. The FDA says the company can begin the CGUARDIANS II pivotal study of the system used during transcarotid revascularization (TCAR) procedures. InspireMD picked Dr. Patrick Geraghty and Dr. Patrick Muck to serve as lead investigators […]
FDA clears hip arthroplasty tech from OrthAlign
OrthAlign announced that it received FDA 510(k) clearance for its Lantern Hip handheld technology for hip arthroplasty. Lantern Hip offers enhanced technology and usability in total hip arthroplasty with patients in the supine position, according to OrthAlign. It adds to the Lantern platform that also features applications for total knee, revision knee and partial knee […]
Corin wins FDA nod for Unity Knee tibial insert for robot-assisted TKA
Corin announced that it received FDA 510(k) clearance for its Unity Knee medial constrained (MC) tibial insert. Cirencester, UK-based Corin designed the Unity Knee MC tibial insert to enhance its overall Unity Knee portfolio. It hopes to give surgeons the option to independently stabilize the medial compartment during a standard or robotic-assisted total knee arthroplasty […]
The top 10 women’s health stories of the year so far
It has been a blockbuster year for women’s health as the federal government and medtech place particular focus on the wellbeing of women. At the start of the year, President Joe Biden announced the federal government would focus its health initiatives on improving women’s health outcomes. Since then, his administration has announced two other federal […]
Globus Medical launches new orthopedic trauma portfolio offerings
Globus Medical (NYSE:GMED) announced that it expanded its orthopedic trauma product portfolio with several new system extensions. The company said it received FDA 510(k) clearance for its first suture-based product, the Tensor suture button system. Additionally, it launched the next-generation Anthem II distal radius volar plates, Autobahn trochanteric nail PRO instruments and Captivate Sola headless […]
BD to settle majority of existing hernia litigation
BD announced that it reached an agreement to resolve the vast majority of its existing hernia litigation. Terms of the settlement agreement — which remain confidential — include cases in the Rhode Island consolidated litigation and federal multidistrict litigation in Ohio. BD has the amount payable within its product litigation reserve for this matter. The […]
The top 10 neurotech stories of the year so far
Across medtech, companies have continued to innovate through the first nine months of 2024, and that rings especially true in the neurotech space. Regulatory achievements, mergers and acquisitions, significant fundraising and more within neurotech have all been topics that garnered the interest of the MassDevice readers so far this year. We even have lists of some […]
