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FDA clears Polymedco’s MI cardiac troponin test
Polymedco has received 510(k) clearance from the US Food and Drug Administration (FDA) for its rapid troponin assay as part …
Novocure’s TTFields device slows metastasis in NSCLC
Novocure’s Tumor Treating Fields (TTFields) therapy met its primary endpoint in the Phase III METIS trial by slowing the progression …
Nexalin’s device improves symptoms of mild traumatic brain injury
Nexalin Technology has revealed positive data from a clinical trial that evaluated its neurostimulation device in veteran patients with combat-related …
Elekta and MSD team up for digital kidney cancer care
Elekta has announced a collaboration with Merck & Co (MSD) to enhance care for individuals with advanced renal cell carcinoma …
Medtronic swings FDA clearance for latest TAVR device
The US Food and Drug Administration (FDA) has granted approval to Medtronic the its Evolut FX+ transcatheter aortic valve replacement …
Photopharmics kickstarts phototherapy trial for Parkinson’s disease
US-based equipment manufacturer Photopharmics has announced the initiation of its ‘Celeste light for PD’ clinical trial investigating the Celeste phototherapy …
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 …
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 …