Medtronic (NYSE:MDT) today announced its UNiD patient-specific rods for its spinal systems won FDA clearance. The UNiD rods are made for use with the medtech giant’s CD Horizon Solera Voyager and Infinity OCT spinal systems, which can be used with the Mazor robotic system. Medtronic designed the rods to be industrially pre-bent before surgery to accurately […]
510(k)
Avicenna.AI’s triage system get regulatory nods
Avicenna.AI announced today that it received FDA 510(k) clearance and CE mark for its Cina Chest vascular condition triage system. Marseille, France-based Avicenna.AI designed Cina Chest to leverage deep learning algorithms to offer automatic detection and triage capabilities for both pulmonary embolism (PE) and aortic dissection (AD) from CT-scan imaging, according to a news release. […]
Edwards’ low-BP prediction software gains FDA clearance
Edwards Lifesciences (NYSE:EW) has announced that its Acumen hypotension prediction index (HPI) software has received FDA 510(k) clearance. Using data obtained from the Acumen IQ finger cuff, the software uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure. Until now, Acumen HPI software has only […]
iRhythm wins FDA clearances for next-gen Zio monitor, AI capabilities
iRhythm Technologies (NSDQ:IRTC) announced that it received FDA 510(k) clearances for updates to its heart rhythm monitoring tech. San Francisco-based iRhythm’s first clearance came for a new and improved design of its flagship wearable Zio monitor and the second covered updated artificial intelligence (AI) capabilities, according to a news release. The Zio ambulatory cardiac monitoring […]
FDA clears EndoFresh disposable digestive endoscope
EndoFresh today said it received FDA 510(k) clearance for its disposable digestive endoscopy system. The system features a camera system with an all-in-one design, disposable upper GI endoscope and disposable colonoscope, which can be used with the company’s medical display and other peripheral devices for physicians to visualize, diagnose and operate gastrointestinal endoscopy. Get the full […]
FDA clears Biorez BioBrace implant technology
Biorez announced that it received FDA 510(k) clearance for two sizes of its BioBrace implant for tendon and ligament procedures. New Haven, Conn.-based Biorez designed its biocomposite soft tissue scaffold for use in a range of surgical procedures to reinforce soft tissue where weakness exists, according to a news release. The implant can be used […]
Bose jumps into hearing aid market
Bose just introduced FDA-cleared, direct-to-consumer hearing aids for adults with mild to moderate hearing loss. Users can use a smartphone app to fit, program and control a SoundControl hearing aid without a doctor visit, hearing test or prescription, according to Framingham, Mass.-based Bose. Each hearing aid will retail for $849.95 starting May 18th in five […]
Think Surgical robot can use Ortho Development implants, FDA says
The FDA has cleared two Ortho Development knee implants for use with a Think Surgical robotic system, the companies announced today. Surgeons will now be able to use Ortho Development’s Balanced Knee system (BKS) and BKS TriMax implants with Think Surgical’s TSolution One total knee arthroplasty system. TSolution One is the only commercially available active robot system for total […]
Bigfoot Biomedical wins FDA clearance for smart insulin pen cap system
Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes management system. Milpitas, Calif.-based Bigfoot’s first-of-its-kind Bigfoot Unity system features connected smart pen caps designed to recommend insulin doses for diabetes patients using multiple daily injection (MDI) therapy, according to a news release. Get the full story at our sister site, […]
BD applies for FDA clearance to start shipping Alaris pumps again
BD (NYSE:BDX) said today that it has applied to the FDA for a new clearance for its recall-plagued Alaris infusion pump system. BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes needed following a Class I-level recall in March 2020. Pumps are only […]
FDA clears Soundbite Medical peripheral crossing system
Soundbite Medical announced that it received FDA 510(k) clearance for its SoundBite crossing system-peripheral. Montreal-based Soundbite Medical’s SoundBite crossing system-peripheral (SCS-P) with the 0.014″ active wire (14P) is a recanalization tool designed to help physicians with the placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions (CTOs). The device […]
