Zimmer Biomet today said it received FDA 510(k) clearance for its Rosa Partial Knee system for robotically-assisted partial knee replacement surgeries. Rosa Partial Knee is the latest addition to Zimmer Biomet’s Rosa Robotics platform, which includes the Rosa Knee system for total knee replacement surgery and Rosa One for neurosurgical and spine procedures. The Rosa […]
Seigla Medical gains CE mark for guide catheter extension
Seigla Medical recently announced that it won CE mark approval for its LiquID guide catheter extension for use in coronary and peripheral vasculature interventions. Guide catheter extensions are used by cardiologists to assist in the delivery of stents and other interventional devices, according to the Minneapolis-based company. Get the full story on our sister site, […]
Contego Medical carotid stent wins CE mark approval
Contego Medical recently announced that it received CE mark approval for its Neuroguard IEP 3-in-1 carotid stent system and post-dilation balloon system with integrated embolic protection. The system has a nitinol stent, a pre-positioned post-dilation balloon and a microembolic filter with 40 μm pores. It has a closed-cell stent that is designed for optimal performance […]
Qorvo wins FDA nod for test that uses acoustic waves to detect COVID-19 antigens
Qorvo this week said it received FDA emergency use authorization for its Omnia SARS-CoV-2 antigen test. The diagnostic platform uses high-frequency bulk acoustic wave (BAW) sensors to test for COVID-19 antigens in approximately 20 minutes, according to the company. BAW sensors enable a low limit of detection levels that are similar to molecular testing capability. […]
Solo-Dex launches peripheral nerve block catheter
Solo-Dex this week launched its Fascile continuous peripheral nerve block catheter. The nerve block catheter is designed to manage pain before, during and after surgery. It activates the facile continuous nerve block catheter quickly and safely for common procedures like shoulder repair, hip and knee replacement and other general surgical procedures. Get the full story […]
BD lands FDA clearance for hemodialysis catheter
BD (NYSE:BDX) this week said it has received FDA 510(k) clearance for its Pristine long-term hemodialysis catheter. The catheter has a side-hole free symmetric Y-tip distal lumen design that is designed to minimize thrombus adhesion and help facilitate blood clot aspiration prior to hemodialysis treatment. Its symmetric tip is designed to help minimize recirculation rates […]
Survey shows solid medical device industry performance despite pandemic
By Stewart Eisenhart, Emergo Group Medical device and IVD manufacturers reported healthy performance over the course of 2020, but also faced significant operational and regulatory challenges related to the coronavirus pandemic. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
Cardinal Health wins $58M federal PPE contract
Cardinal Health (NYSE: CAH) today said it was awarded a $57.8 million contract from the U.S. Dept. of Health and Human Services to support the Strategic National Stockpile. The Dublin, Ohio-based company received the contract, which includes options that if exercised by the HHS could reach $91.6 million, to store and distribute 80,000 pallets of personal […]
Endologix acquires PQ Bypass
Endologix today announced that it has completed its acquisition of PQ Bypass for an undisclosed amount. PQ Bypass makes the Detour platform that is designed for percutaneous femoral-popliteal bypass — providing a large lumen, endograft bypass to treat abdominal aortic aneurysm. FDA has designated Detour as a breakthrough device. The Detour System has the company’s […]
Zoll Medical acquires Respicardia
Zoll Medical said today that it has acquired Respicardia and its neurostimulation tech for treating sleep apnea. The financial terms of the deal were not disclosed. Respicardia makes implantable neurostimulators to treat moderate to severe central sleep apnea (CSA). The system is FDA approved to treat severe CSA in adult patients with reduced cardiac function. […]
Crown Aesthetics wins FDA clearance for wrinkle treatment device
Crown Aesthetics this week said it received FDA clearance for its SkinPen Precision device for treating wrinkles on the neck. The SkinPen Precision microneedling technology is safe for use with a depth of up to 2.5mm on the neck, according to the company. It is intended to be used as a treatment to improve the […]