Startup spinal implant company Carlsmed and startup spine imaging system company Precisive Surgical have completed a merger to develop a personalized surgical workflow platform. The system will combine clinical intelligence, advanced image recognition, and 3D printing to enable earlier surgical intervention delivering personalized implants to patients with complex, multi-level spinal alignment deviation, according to San Diego-based Carlsmed. The system […]
The 17 most innovative medical devices of 2019
The Galien Foundation recently announced nominees for most innovative medical devices for its 13th Annual Prix Galien USA Awards. The foundation awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Nominees need to be FDA approved for market within the last five […]
Osseus Fusion Systems acquires SIJ Surgical
Implantable spine products maker Osseus Fusion Systems (Dallas, Texas) said it has acquired SIJ Surgical. SIJ Surgical’s SI screw system has distal cutting flutes, dual lead threads, and fenestrated, open implant architecture designed to improve osseointegration and reduce radiographic signature, according to Osseus. Get the full story on our sister site, Medical Design & Outsourcing.
FDA warns of magnetic interference involving hearing devices
The magnets in some hearing implants may interfere with the operation of programmable cerebrospinal fluid (CSF) shunt systems used to treat hydrocephalus, causing over- or under-drainage, the FDA warned yesterday. Magnetic interactions between cochlear implants, bone-conduction hearing devices or middle-ear hearing devices implanted too closely to shunt systems may “ lead to unintended changes to […]
Australia eyes ban on textured breast implants
Australia’s TGA said last week that it concluded breast implants do not need to be removed as breast implant-associated anapestic large cell lymphoma (BIA-ALCL) is rare. The regulatory body said in April that is was considering implementing a ban on textured breast implants and was seeking new data from suppliers of the implants to decide […]
Taris Bio, Bristol-Myers Squibb launch bladder cancer trial
Taris Biomedical has announced the dosing of the first patient in a study of its TAR-200 system plus a programmed immune checkpoint inhibitor for the treatment of muscle-invasive bladder cancer (MIBC). The TAR-200 system continuously delivers the chemotherapy drug gemcitabine in the bladder for multiple weeks. The combination with Bristol-Myers Squibb’s Opdivo (nivolumab) will be assessed for […]
NeuroPace epilepsy tech to be studied for binge eating
NeuroPace said today that its epilepsy neuromodulation technology will be studied for its efficacy in treating binge-eating disorder in certain patients. The Mountain View, Calif.-based company’s RNS system is a closed-loop technology approved to treat adults with medically refractory focal onset epilepsy. The clinical trial will examine whether neuromodulation could help patients with a body […]
Cardiologist questions use of Boston Scientific Watchman device
A Philadelphia cardiologist has written a newspaper column questioning the efficacy and cost of Boston Scientific’s Watchman device for stroke prevention. The Watchman left atrial appendage closure device is designed to prevent blood clots that form in the heart’s left atrial appendage from reaching the brain. Boston Scientific (NYSE:BSX) markets it as an alternative to blood-thinning […]
How one medtech company is working on solving the data dilemma
The electronic medical record was designed to better track patient care, but it has had unintended consequences. Physicians are bombarded with digital patient information all day long, reducing their patient eye-to-eye interactions and adding hours to their workday. A 2016 American Medical Association study found that physicians spent about two hours on electronic health record […]
Study: Boston Sci’s Watchman cheaper than drugs long-term
Updated to include comments from the principal investigator. A new study has found that use of the Boston Scientific (NYSE:BSX) Watchman left atrial appendage closure (LAAC) device to treat atrial fibrillation costs less than existing and novel anticoagulant drugs over five years. Researchers conducted the analysis using an Excel-based simulation model developed to assess the […]
First patients implanted with Exactech’s non-cemented Truliant knee
Exactech (NSDQ:EXAC) today announced the successful first surgeries involving its Truliant Porous knee implant. Truliant Porous is a non-cemented implant system that Exactech said is designed for reproducibility and efficiency in total knee arthroplasty. Truliant Porous is designed to reduce micromotion and aid potential bony in-growth, according to the company. The system features a unique […]
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