Electrophysiology dominates atrial fibrillation with PFA tech
Most doctors now prefer to use PFA catheters over traditional ablation methods. Credit: MAD.vertise via Shutterstock. Pulsed field ablation (PFA) technology has been dominating the electrophysiology market. According to key opinion leaders (KOLs) from Europe, most doctors now prefer to use PFA catheters over traditional ablation methods, which typically include thermal or cryo energy, because […]
Sleepiz wins FDA clearance for device that measures vitals during sleep
The FDA Class II 510(k) clearance means physicians can now prescribe the device to their patients for home monitoring. Credit: Sleepiz. The US Food and Drug Administration (FDA) has cleared Sleepiz’s bedside device that monitors patients’ vital signs during sleep. The Sleepiz One+ device uses radar technology for contactless monitoring of breathing patterns, respiration rate […]
Endotronix obtains FDA IDE approval for Cordella Sensor study
The multicentre trial will support efficient and scalable remote patient management. Credit: Parinya.Maneenate/Shutterstock.com. Endotronix has obtained investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for the subsequent multicentre study to evaluate the Cordella Sensor for pulmonary artery (PA) pressure-guided therapy. Known as PROACTIVE-HF 2, the dual-arm prospective study intends to […]
Noul unveils miLab Cartridge CER cervical cell analysis product
Noul’s miLab Cartridge CER product has been introduced at the International Federation of Gynecology and Obstetrics 2023. Credit: PRNewsfoto/Noul. Artificial intelligence (AI)-based blood and cancer diagnostic platform company Noul has unveiled a cervical cell analysis product, miLab Cartridge CER, designed to automatically stain and analyse cervical cells. The new product stains cervico-viginal samples smeared manually […]
FDA grants Endotronix’s Cordella sensor IDE for second heart failure study
The sensor provides heart pressure readings for the Cordella system, a haemodynamic monitoring system. Credit: Shutterstock/Enmaler. The US Food and Drug Administration (FDA) has granted Endotronix’s Cordella sensor Investigational Device Exemption (IDE) for a second multicentre study, meaning the sensor system’s future use could be expanded to more heart failure patients. Illinois, US-based Endotronix has […]
HistoSonics receives authorisation for histotripsy platform
HistoSonics Edison histotripsy system is intended for the non-invasive destruction of liver tumours. Credit: HistoSonics/Business Wire. HistoSonics has received marketing authorisation from the US Food and Drug Administration (FDA) for its Edison histotripsy platform. Approved through the De Novo Classification Request process, Edison is claimed to be the first and only histotripsy platform available in […]
Co-bots and automatons: the divergent futures of robotics
Robots are used across industries, like this cleaning robot in Hangzhou. Photo: Costfoto/NurPhoto via Getty Images. Robotics is a surprisingly old discipline, arguably beginning in ancient Egypt, where human-esque figurines were built into water clocks to automatically strike bells on the hour. The human obsession with the creation of ‘automata’ runs throughout human history, but […]
DePuy Synthes gains FDA 510(k) clearance for thoracolumbar implant system
The TriATLIS Spine System is a thoracolumbar pedicle screw system with a portfolio of instruments compatible with DePuy Synthes’ enabling technologies. Credit: DePuy Synthes DePuy Synthes a Johnson & Johnson orthopaedics company has been awarded US Food and Drug Administration (FDA) 510(k) clearance for its thoracolumbar implant system, TriATLIS Spine System, and its Navigation Enabled […]
Q&A: The potential of 3D bioprinting medical devices
Interview with Vidmantas Šakalys, CEO of Vital 3D Technologies. Explore the future of personalised medicine and medical devices in this exclusive interview with Vidmantas Šakalys, CEO of Vital 3D Technologies. Learn how this technology could reshape healthcare by creating custom-made tissues, organs, bones and medical implants tailored to individual patients’ needs. Access the most comprehensive […]
A new age for mental health and tech
Despite the fall of telehealth pioneer Babylon Health, GlobalData expects the market, which was worth $690m in 2015, to reach $3.8bn by 2030. Mental health is an area that will see the greatest usage. Credit: Koshiro K/Shutterstock. Technology and mental health have had a long, mutually beneficial relationship. Many argue that with the rise of […]