Smith & Nephew (NYSE:SNN) today announced the launch of its new Journey II Unicompartmental Knee System. The system is a highly personalized approach to partial knee arthroplasty through a modular, two tray configuration. It works by introducing a lateral specific tibia baseplate and an increased size range for femoral components and medial tibia baseplates to optimize […]
G Medical Innovations ECG Patch receives FDA EUA for use in COVID-19 patients
G Medical Innovations recently announced that it received FDA emergency use authorization for its vital signs monitoring system ECG patch for remote monitoring of patients who are being treated for COVID-19. The patch monitors the QT interval of an ECG in patients to watch for fatal arrhythmias that may occur from treatment drugs. Prolonged QT […]
Cochlear wins FDA approval to lower age to implant to 9 months
Cochlear Ltd. (ASX:COH) has received FDA approval to lower the age of cochlear implantation to nine months for children. The new approval lowers the age from the original 12 months for children with bilateral, profound sensorineural hearing loss. Cochlear implants have been FDA approved for use in children since 1990. “In light of all that has […]
Electromed appoints new chief financial officer
Electromed has appointed Michael MacCourt as chief financial officer. MacCourt brings nearly two decades of financial leadership and multidimensional business experience in medical devices to the company, Electromed said yesterday. Prior to joining Electromed, MacCourt was the senior director of commercial finance at Starkey Hearing Technologies. He has also spent over nine years in leadership […]
Aesculap launches hydrocephalus valve
Aesculap recently launched its M.blue hydrocephalus valve. The valve is adjustable gravitational valve that features an integrated fixed pressure differential valve during the most active time of the day, according to the company. The fixed pressure differential valve addresses posture changes. “We are very pleased to be able to continue to provide healthcare teams with […]
Sight Sciences touts positive study results of dry eye treatment device
Sight Sciences today announced positive results from a clinical trial of its TearCare wearable eyelid technology. The Olympia study was a prospective, randomized multicenter trial that enrolled 235 dry eye patients across 10 sites in the U.S. The goal was to demonstrate the safety and effectiveness of a single TearCare procedure compared to the LipiFlow […]
How AI could help health providers diagnose COVID-19
When it comes to diagnosing treating COVID-19, timeliness is imperative to avoid patient deaths. Several companies are developing artificial intelligence-based algorithms to help doctors analyze and diagnose COVID-19 in patients quickly. The coronavirus has affected more than 3.7 million people globally, with the U.S. experiencing the most COVID-19 cases at just over 1.2 million so […]
Eudamed updates phased implementation for European medical device, IVD database
By Ronald Boumans, Emergo Group The implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the implementation of the Medical Devices Regulation (MDR) has been delayed by one year. The European Commission has informed Emergo that parts of Eudamed will be made available to users before the official […]
Minerva Surgical closes on Boston Sci intrauterine health franchise buy
Minerva Surgical today said it closed the acquisition of Boston Scientific’s intrauterine health franchise. The financial details of the deal were not disclosed. The new combination of devices includes the Minerva Endometrial Ablation System and the Genesys HTA Endometrial Ablation System for visualization in the uterine cavity during treatment. The deal also includes the Symphion […]
Endologix shares fall on missed Q1 projections
Endologix (NSDQ:ELGX) posted first-quarter results that missed the consensus forecast on Wall Street and cut its outlook for the rest of the year. The company — maker of endovascular stent-grafts for the treatment of abdominal aortic aneurysms (AAA) — reported losses of -$18.1 million, or -90¢ per share, on sales of $28.5 million for the three […]
Fitbit launches wearable AFib detection study
Fitbit (NYSE:FIT) recently announced it launched its first large-scale, virtual study to validate the use of its wearables in atrial fibrillation detection. The Fitbit Heart Study is part of Fitbit’s larger strategy to make easy-to-use tools for the detection of a range of conditions. The goal of the study is to enroll hundreds of thousands of […]