Elekta, MSD team up for digital kidney cancer care
The partnership focuses on developing a digital module for renal cell carcinoma. Credit: Marko Aliaksandr/Shutterstock.com. Elekta has announced a collaboration with Merck & Co (MSD) to enhance care for individuals with advanced renal cell carcinoma (RCC) through the use of digital patient monitoring. This initiative utilises Elekta’s digital health interventions platform, Kaiku Health, for patient […]
Beacon obtains US FDA clearance for SleepStageML software
The SleepStageML is expected to reduce variability in human scoring. Credit: Gorodenkoff/Shutterstock.com. Beacon Biosignals has secured the US Food and Drug Administration’s (FDA) 510(k) clearance for SleepStageML, a machine learning software designed to enhance sleep analysis. This development expands the company’s analytical capabilities, extending from at-home sleep monitoring to include in-lab polysomnography, a traditional method […]
FDA issues 510(k) clearance for Synaptive’s fluorescence module
Synaptive Medical’s Modus X robotic exoscope. Credit: Synaptive Medical/ Globe Newswire. The US Food and Drug Administration (FDA) has issued 510(k) clearance to Synaptive Medical’s near-infrared (NIR) fluorescence visualisation module, Modus IR. This enhancement is integrated into the company’s Modus X robotic exoscope, a high-definition digital imaging system equipped with advanced fluorescence capabilities. The Modus […]
Photopharmics kickstarts phototherapy trial for Parkinson’s disease
The number of Parkinson’s cases will grow to nearly three billion in 2029 in the seven major markets, according to GlobalData. Credit: ESB Professional via Shutterstock. US-based equipment manufacturer Photopharmics has announced the initiation of its ‘Celeste light for PD’ clinical trial investigating the Celeste phototherapy device. The US Food and Drug Administration (FDA)-approved device […]
Medtronic swings FDA clearance for latest TAVR device
The total global market for TAVR devices is expected to be worth $6.8bn in 2023 and reach $18.8bn in 2033. Credit: Shutterstock / ShutterOK. The US Food and Drug Administration (FDA) has granted approval to Medtronic the its Evolut FX+ transcatheter aortic valve replacement (TAVR) system. The device is designed for the treatment of symptomatic […]
GE HealthCare launches PVA urology-based AI software feature
The PVA is designed to improve the workflow for urologists. Credit: 3rdtimeluckystudio/Shutterstock.com. GE HealthCare has announced the launch of Prostate Volume Assist (PVA), an AI software feature aimed at enhancing urological imaging and treatment. This AI-enabled feature is set to automate the manual process of generating prostate volume measurements, a critical factor in diagnosing and […]
J&J reportedly eyeing Shockwave Medical for takeover
The C²⁺ IVL catheter is marketed in select international markets. Credits: Monkey Business Images/Shutterstock.com. Johnson & Johnson (J&J) is allegedly looking to strengthen its presence in the cardiovascular device market with the acquisition of medical device company Shockwave Medical, as first reported by the Wall Street Journal (WSJ) on 26 March. The WSJ cited people […]
Ypsomed to sell pen needle and BGMs businesses to MTD
Ypsomed plans to increase autoinjectors production capacities at the Solothurn site. Credit: Ypsomed. Swiss medical technology company Ypsomed has signed an agreement to sell its pen needle and blood glucose monitoring systems (BGMs) businesses to Medical Technology and Devices (MTD). The sale forms part of Ypsomed’s efforts to focus on its diabetes care business, with […]
NeuroOne begins limited launch of OneRF Ablation System
The system can create RF lesions in nervous tissue for functional neurosurgical procedures. Credit: Atthapon Raksthaput/Shutterstock.com. NeuroOne Medical Technologies has announced the limited commercial launch of its OneRF Ablation System, a thin-film, stereoelectroencephalography (sEEG)-guided radiofrequency (RF) system. The system received 510(k) clearance from the US Food and Drug Administration (FDA) in December 2023 for the […]
Endostart bags FDA 510(k) clearance for magnetic colonoscopy device
The US market authorisation follows a multicentre clinical trial designed to demonstrate the safety of the Endorail device. Credit: Shutterstock / Roman Zaiets. Italian medical device company Endostart has secured US Food and Drug Administration (FDA) 510(k) clearance for its colonoscopy device, which is designed to optimise prolonged gastrointestinal procedures. Named Endorail, the US market […]