Endotronix announced positive six-month results from a pivotal trial evaluating its Cordella pulmonary artery (PA) sensor. Naperville, Illinois-based Endotronix designed Cordella to enable proactive, data-driven heart failure (HF) management. It aims to engage patients, reduce and prevent congestion and improve outcomes. The PROACTIVE-HF trial evaluates Cordella in NYHA Class III HF patients at risk of […]
Implants
Orthofix beats Street in Q4, analysts see positive signs for future
Orthofix Medical are up today on fourth-quarter results that topped the consensus forecast. The Lewisville, Texas–based company posted losses of $22.2 million in the quarter. That equals 59¢ per share on sales of $200.4 million for the three months ended Dec. 31, 2023. The company’s bottom line dipped by more than $15 million further into […]
Vivani prices $15M offering to support long-term drug delivery implant
Vivani Medical (Nasdaq:VANI) announced today that it entered into a securities purchase agreement worth $15 million in proceeds. The company entered the agreement with an institutional investor. It covers the purchase of just shy of 4 million shares of common stock and warrants to purchase common stock. Alameda, California-based Vivani priced the shares at $3.80 […]
FDA reportedly finds animal lab issues at Neuralink facility
Reuters reports that FDA inspectors identified issues with record keeping and quality controls for animal experience at Neuralink. This isn’t the first time questions have been raised over the Elon Musk-backed brain-computer interface company’s animal practices. Over the past couple of years, the company has drawn concerns over animal welfare and hazardous material transport practices. Reuters‘ report […]
FDA submission for 365-day CGM from Senseonics is ‘imminent’
Senseonics (NYSE:SENS) shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast. The company also reported an “imminent” submission of its latest, longest-lasting continuous glucose monitoring (CGM) technology. Shares of SENS fell 3.5% to 69¢ apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of […]
Affluent Medical has positive biomimetic mitral valve data
Affluent Medical today announced positive findings in a clinical evaluation of its Epygon device for replacing mitral valves. The Aix-en-Provence, France-based company designed Epygon to replace mitral valves in those with mitral insufficiency. Epygon is the first biomimetic transcatheter mitral valve to mimic the native mitral valve and restore the natural vortex of blood flow […]
Onward wins FDA breakthrough nod for use of neurostim with brain-computer interface
Onward Medical announced today that the FDA granted breakthrough device designation for its ARC-BCI system that uses brain-computer interface (BCI) technology. ARC-BCI uses BCI technology in conjunction with ARC-IM neurostimulation. It aims to restore thought-driven lower limb mobility after spinal cord injury (SCI). The BCI system uses AI to decode brain signals and translate them […]
Medtronic asks ITC to stop Axonics’ sales of neuromod devices
Medtronic today announced that it filed a complaint to the U.S. International Trade Commission (ITC) to block the sales of certain Axonics (Nasdaq:AXNX) devices. The complaint to the ITC runs parallel to action in the U.S. District Court for the District of Delaware. Medtronic wants to block Axonics from “improperly importing and selling products that infringe […]
FDA clears sacroiliac joint fusion device from Nevro
Nevro (NYSE:NVRO) announced today that the FDA cleared its sacroiliac (SI) joint fusion device without the need to include an accompanying screw. Redwood City, California-based Nevro plans to market this device as Nevro1, without the need for the NevroFix screw. The system aims to immediately transfix the SI joint, allowing the opportunity for long-term fusion. […]
BlueWind reports first patient treated in study of neuromod for urinary incontinence
BlueWind Medical announced today that a doctor treated the first patient in the RESTORE study of its Revi iTNM device. Dr. Osvaldo Padron of Florida Urology Partners in Tampa, Florida, treated the first patient. The prospective, multi-center, open-label, post-market, randomized controlled trial aims to recruit 150 patients across up to 20 U.S. centers. BlueWind designed Revi […]
Smith+Nephew sales are up 7% as 12-point plan progresses
Smith+Nephew shares dipped today on fourth-quarter results that included nearly 7% sales growth year-over-year. Shares of SNN fell 2% to $27.97 apiece in late-afternoon trading. The London-based orthopedic giant posted sales of $1.458 million in the quarter. That marked 6.8% growth compared to the same period a year ago. Smith+Nephew says it continues to make […]