Moon Surgical’s Maestro system used in first US clinical procedures
Maestro being used in a procedure. GlobalData valued the surgical robotics 2021 market at $9.6bn. Image credit: Moon Surgical. Surgeons in the US have used Moon Surgical’s Maestro system to aid weight loss surgery procedures, in what are the first-use cases of the robotic system in the country. Maestro, which received US Food and Drug […]
Edwards Lifesciences named as the manufacturer targeted by EU antitrust raid
According to a GlobalData report, global market value for cardiovascular devices will grow at a compound annual growth rate (CAGR) of 6% to $62 billion by 2025. Credit; symbiot/Sutterstock Edwards Lifesciences, has been identified as the company subject to unannounced raids by the EU commission on September 19th, 2023. The raid was conducted as part […]
SpineX receives funds to complete trial of the SCiP device
In investigational studies, the SCiP technology has demonstrated the ability to treat the root cause of CP through spinal cord neuromodulation. Credit: SpineX/Business Wire. SpineX has received funds to complete a pivotal clinical trial of the SCiP device in children with cerebral palsy (CP), a movement disorder in childhood. The National Institutes of Health, through […]
IR-MED plans usability study for PressureSafe device ahead of US launch
Pressure injuries are ulcers (sores) which can develop in patients with limited or no mobility who are either bedridden, unconscious, or unable to sense pain. Image Credit: Albina Gavrilovic / Shutterstock. IR-MED has signed a Clinical Trial Agreement with the Methodist Healthcare System of San Antonio to conduct a usability study of its PressureSafe device […]
Senseonics concludes adult cohort of Eversense system trial
The study data will support the submission of the first 365-day continuous glucose monitoring system to the US FDA. Credit: Andrey_Popov/Shutterstock.com. Senseonics has concluded the adult cohort of the ENHANCE pivotal clinical trial of Eversense after the recently completed 365-day visit for the last study subject. The ENHANCE trial is designed to assess the Eversense […]
Oxford BioDynamics rolls out prostate screening blood test in US
The patient’s doctor completes the test through a simple ordering system. Credit: Tatiana från Pixabay. Oxford BioDynamics (OBD) has announced the launch of its EpiSwitch Prostate Screening (PSE) blood test in the US, following its validation in a clinical laboratory. The PSE test is conducted in conjunction with a standard prostate-specific antigen (PSA) test to […]
Galen receives authorisation from US FDA for ENT robotic system
The new cooperatively powered surgical assist device is intended for ear, nose and throat surgery. Credit: Phonlamai Photo/Shutterstock.com. Galen Robotics has received a De Novo classification grant and authorisation from the US Food and Drug Administration (FDA) for its Galen ES Robotic System. The authorisation will enable the marketing of the device for use in […]
Healthyr and Koning Health partner to provide breast health solutions
Healthyr’s at-home testing solutions will be combined with Koning’s imaging technology to detect breast health issues. Credit: Okrasyuk/Shutterstock.com. Healthyr has entered a strategic partnership with Koning Health to provide advanced, non-invasive breast health solutions for women across the world. The partnership aims to integrate Healthyr’s at-home testing solutions with the imaging technology of Koning for […]
SHL Telemedicine’s at-home ECG device reduces hospital visits for patients
SHL plans to begin direct-to-customer sales for SmartHeart in the second half of 2023. Image Credit: Alena Yudina / Shutterstock. SHL TeleMedicine has presented initial data from two clinical trials of its SmartHeart, showing a reduction in hospital visits in post-myocardial infarction (MI) patients. The results are from two clinical trials, HELP-MI and TELE-ACS, which […]
Enovis to acquire LimaCorporate in $847m deal
Image credit: Shutterstock/macgyverhh US-based orthopedics company Enovis has announced plans to acquire surgical implant maker LimaCorporate S.p.A (Lima), to expand its global reach and portfolio of products. Under the terms of the agreement, Enovis will obtain Italy-based Lima in a transaction valued at €800 million ($847 million) made up of a cash payment of €700 […]