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FDA issues 510(k) clearance for Synaptive’s fluorescence module
The US Food and Drug Administration (FDA) has issued 510(k) clearance to Synaptive Medical’s near-infrared (NIR) fluorescence visualisation module, Modus …
Beacon obtains FDA clearance for SleepStageML software
Beacon Biosignals has secured the US Food and Drug Administration’s (FDA) 510(k) clearance for SleepStageML, a machine learning software designed …
GE HealthCare launches PVA urology-based AI software feature
GE HealthCare has announced the launch of Prostate Volume Assist (PVA), an AI software feature aimed at enhancing urological imaging …
Ypsomed agrees for pen needle and BGMs businesses sale to MTD
Swiss medical technology company Ypsomed has signed an agreement to sell its pen needle and blood glucose monitoring systems (BGMs) …
J&J reportedly eyeing Shockwave Medical for takeover
Johnson & Johnson (J&J) is allegedly looking to strengthen its presence in the cardiovascular device market with the acquisition of …
Ypsomed agrees for pen needle and BGMs businesses sale to MTD
Swiss medical technology company Ypsomed has signed an agreement to sell its pen needle and blood glucose monitoring systems (BGMs) …
J&J reportedly eyeing Shockwave Medical for takeover
Johnson & Johnson (J&J) is allegedly looking to strengthen its presence in the cardiovascular device market with the acquisition of …
Leading healthcare cloud computing companies and service providers in medical devices
Cloud computing provides a myriad of benefits to the medical devices space, including a cost-reduced approach towards patient-doctor communications, increasing …
Roche wins FDA approval for first test to detect malaria in blood donors
The US Food and Drug Administration (FDA) has approved a molecular test from Roche Diagnostics that screens blood donors for …
Cleerly touts new data for AI cardiovascular software
Digital healthcare company Cleerly has announced that positive data from two studies investigating its AI-QCT ISCHEMIA software device has been …
Implantica gears up for FDA approval of acid reflux device
Implantica has started the premarket approval process with the US Food and Drug Administration (FDA) for its gastroesophageal reflux disease …
Oncology in 2024: The clinical trial trends reshaping the role of CROs
Oncology is the most active area in clinical trials globally this year, as more resources than ever are being dedicated …
Endostart bags FDA 510(k) clearance for magnetic colonoscopy device
Italian medical device company Endostart has secured US Food and Drug Administration (FDA) 510(k) clearance for its colonoscopy device, which …
Stemcell’s EasySep CD138 Selection Kit receives FDA de novo classification
The US Food and Drug Administration (FDA) has granted de novo classification to STEMCELL Technologies’ EasySep Human Bone Marrow CD138 …
NeuroOne begins limited commercial launch of OneRF Ablation System
NeuroOne Medical Technologies has announced the limited commercial launch of its OneRF Ablation System, a thin-film, stereoelectroencephalography (sEEG)-guided radiofrequency (RF) …