Stroke treatment developer Silk Road Medical (NSDQ:SILK) announced that it promoted Andrew Davis as its new chief commercial officer. In the newly created role at the Sunnyvale, Calif.-based company, Davis is slated to oversee Silk Road Medical’s global commercialization efforts by establishing near-term priorities and setting the long-term strategic direction for the organization, according to a […]
UK warns on spinal fixation system from Depuy Synthes
The United Kingdom issued a warning for failure in a spinal fixation system manufactured by Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes. An alert sent out by the Medicines and Healthcare Products Regulatory Agency highlighted an issue with the cracking of the USS II Polyaxial 3D head rings that may result in the loosening of the spinal […]
FDA clears Infervision’s lung CT.AI system
Infervision announced that it received FDA 501(k) clearance for its InferRead Lung CT.AI system which uses AI to automatically perform lung segmentation. InferRead Lung CT.AI is designed to use AI and deep learning technology to support concurrent reading and aid radiologists in pulmonary nodule detection during the review of chest CT scans, increasing accuracy and […]
Philips launches new face scanning tech, partners with BioIntelliSense on telehealth
Royal Philips (NYSE:PHG) today announced two separate steps toward helping patients receive remote care as telehealth’s importance continues to grow. Amsterdam-based Philips said today that it launched its Philips Respironics mask selector 3D facial scanning system for fitting masks and formed a strategic collaboration with BioIntelliSense to monitor at-risk patients from the hospital into the home. […]
FDA clears new Baxter bone graft substitute
Baxter (NYSE:BAX) announced today that it received FDA clearance for its Altapore Shape bioactive bone graft for bone growth and fusion. Deerfield, Ill.-based Baxter’s Altapore Shape is its latest addition to its bone graft substitute product line, designed to enhance bone growth and aid in achieving fusion, leading to reduced pain and other improved clinical outcomes […]
Myomo launches MyoCare
Myomo (NYSE:MYO) announced today that it launched its MyoCare program for providing support to first-year users of its MyoPro powered brace. MyoCare offers expanded support to current and future clients who receive their MyoPro directly from the Cambridge, Mass.-based company, at no additional cost. Anyone who obtained the MyoPro from an authorized orthotics & prosthetics clinic […]
Balt receives CE Mark for flow diverting shunt
Balt announced that it received CE Mark approval for its Silk Vista flow diverting stent for treating patients with unruptured intracranial aneurysms. Montmorency, France.-based Balt designed its Silk Vista device for predictable and accurate deployment and high visibility under angiography, adding to its already-CE-Marked Silk Vista baby flow diverter, which has been approved in Europe […]
Eko names Humbarger as new SVP
Eko announced yesterday that it appointed Bryan Humbarger as its new senior vice president of commercial with an emphasis on sales. The digital health sales veteran’s new role includes responsibilities for overseeing sales and commercial operations for Eko’s AI and telemedicine software platforms for health systems, practices and providers worldwide, according to a news release. […]
iVWatch lands FDA clearance for continuous intravenous monitoring device
Continuous IV monitoring system developer ivWatch announced that it received FDA clearance for its new SmartTouch disposable sensor. SmartTouch is indicated for the early detection of peripheral IV infiltration and extravasation events. The latest FDA clearance expands ivWatch’s sensor portfolio to include the single-use sensor for all patient age groups. It is miniaturized and disposable and […]
Essure study shows more pain, bleeding in women with implant
Interim results from a postmarket study of the Bayer (ETR:BAYN) Essure permanent birth control device revealed higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared with laparoscopic tubal ligation as permanent birth control. The FDA posted the results as part of a long-term safety evaluation of the device, which has […]
Hologic launches first cart-based ultrasound system in U.S.
Hologic (NSDQ:HOLX) announced today that it launched its SuperSonic MACH 40 premium, cart-based ultrasound system in the U.S. The Marlborough, Mass.-based company touts the SuperSonic platform as its first cart-based system, saying in a news release that the new system features strong image quality, standard-setting imaging modes and design to enhance efficiency and accuracy. SuperSonic uses […]
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