Stryker (NYSE:SYK) announced today that it launched its EasyFuse dynamic compression system for its ankle and foot portfolio. Kalamazoo, Michigan-based Stryker designed its EasyFuse dynamic compression system to decrease surgical complexity, provide strong dynamic-compression implants and reduce waste in the operating room. The company created the system using nitinol, a nickel titanium alloy metal known […]
Implants
Boston Scientific’s Acurate Neo2 valve performs well in studies
Boston Scientific (NYSE:BSX) announced positive outcomes from studies of its Acurate Neo2 aortic valve system. Initial outcomes from the Neo-Align study of 170 patients who underwent transcatheter aortic valve implantation (TAVI) with Acurate Neo2 using a novel implant technique to attempt commissural alignment of the prosthetic and native valves demonstrated that commissural alignment can be […]
FDA clears Accelus’ Toro-L interbody fusion system
Accelus announced today that it received FDA 510(k) clearance for its Toro Lateral (Toro-L) interbody fusion system. Palm Beach Gardens, Florida-based Accelus designed its Toro-L biplanar expandable lateral implant for a minimal insertion profile nad maximum bone graft delivery through the inserter. Toro-L includes a 14mm-wide insertion profile, expanding to the implant’s full width of […]
Globus Medical announces first surgeries with Excelsius3D
Globus Medical (NYSE:GMED) announced today that the first surgeries were performed with its Excelsius3D imaging platform. Audobon, Pennsylvania-based Globus Medical designed its intelligent, intraoperative 3-in-1 imaging platform as a mobile X-ray system for 2D fluoroscopy, 2D digital radiography and 3D imaging of adult and pediatric patients. Its indication covers where a physician benefits from 2D […]
NeuroMetrix’s Quell neuromodulation device wins FDA de novo nod to treat fibromyalgia
NeuroMetrix (Nasdaq:NURO) announced today that it received FDA de novo authorization for its Quell neuromodulation device. Quell received the authorization as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. Quell garnered FDA breakthrough device designation to treat fibromyalgia in July 2021. Much like when it received the breakthrough nod, […]
Medtronic’s Resolute Onyx drug-eluting stent demonstrates strong safety, efficacy
Data presented today at the EuroPCR 2022 event supported the use of the Medtronic (NYSE:MDT) Resolute Onyx drug-eluting stent. University of Padua Medical School Head of Interventional Cardiology Dr. Giuseppe Tarantini presented late-breaking clinical trial results from the investigator-initiated, Medtronic-funded ROLEX (Revascularization Of LEft Main With Resolute onyX) registry. ROLEX, the largest real-world, multicenter prospective study, observed […]
Exactech announces breakthrough nod for JointMedica’s hip resurfacing system
Exactech announced today that the FDA granted a breakthrough device designation to JointMedica’s Polymotion hip resurfacing system. Gainesville, Florida-based Exactech, a minority shareholder of JointMedica, collaborates with the United Kingdom-based orthopedic device designer and manufacturer on next-generation hip resurfacing and holds exclusive global distribution rights to the product. “This designation by the FDA is a […]
How Stryker includes users for product design in the digital age
Medical device developers and manufacturers like Stryker (NYSE:SYK) are changing how they approach design as digital technology becomes more crucial. Four Stryker executives shared how the Kalamazoo, Michigan–based orthopedic device giant is thinking differently about medical product development and how health care providers and patients will ultimately use them. The DeviceTalks Boston panel of Stryker […]
Medtronic completes Intersect ENT acquisition
Medtronic (NYSE:MDT) announced that it completed its previously announced $1.1 billion acquisition of Intersect ENT (Nasdaq:XENT). Fridley, Minnesota-based Medtronic announced in August 2021 that it would acquire all outstanding shares of the Menlo Park, California-based sinus implant maker for $28.25 per share in an all-cash transaction. As a result of the transaction, Medtronic acquires Intersect […]
FDA approves magnetic resonance labeling for CVRx’s Barostim neuromodulation system
CVRx (Nasdaq:CVRX) announced today that the FDA approved magnetic resonance (MR) conditional labeling for its Barostim system. The Barostim neuromodulation system for treating the symptoms of heart failure now includes instructions to allow for safe MRI scans of the head and lower extremities, offering heart failure patients implanted with Barostim more diagnostic options. Minneapolis-based CVRx […]
Axonics raises 2022 sales guidance on Street-beating Q1
Axonics Modulation Technologies (Nasdaq:AXNX) reported first-quarter financial results that topped analysts’ consensus forecast. The Irvine, California–based sacral neuromodulation technology developer posted losses of $22.7 million, or 50¢ per share, on sales of $48.4 million for the three months ended March 31, 2022, for a slight bottom-line loss of just over $150,000 year-over-year on sales growth […]