FDA grants breakthrough device designation To Bio-Techne’s ExoDx pPostate IntelliScore test
Bio-Techne announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx…
Apollo Endosurgery announces US labeling update on ORBERA intragastric balloon system
Apollo Endosurgery, a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, has received FDA…
Top AI-powered asthma inhaler brands to lower the impacts of air pollution
Dangerous levels of air pollution is causing millions of deaths in UK, here we look at the top…
Agilent companion diagnostic wins expanded FDA approval in HNSCC
Agilent Technologies announced that the US Food and Drug Administration (FDA) has approved its PD-L1 IHC 22C3 pharmDx…
Ivenix Infusion System wins 510(k) clearance from FDA
The US Food and Drug Administration (FDA) has issued 510(k) clearance for the Ivenix Infusion System, ushering in…
Motus GI secures FDA approval to market Pure-Vu GEN2
Motus GI Holdings, a medical technology company focused on colonoscopy devices, announced that US Food and Drug Administration…
FDA approves Masimo’s O3 regional oximetry for infant patients
Medical technology firm Masimo has secured clearance from the US Food and Drug Administration (FDA) for its O3…
Senseonics gets FDA approval for non-adjunctive indication for Eversense 90-day CGM system
Senseonics Holdings announced that they received FDA approval for the non-adjunctive indication (dosing claim) for the Eversense Continuous…
Gore gets FDA approval for Cardioform ASD occlude to treat atrial septal defects
W. L. Gore & Associates (Gore) has secured approval from the US Food and Drug Administration (FDA) for…
Misonix secures FDA clearance for ultrasonic surgical platform Nexus
Misonix, a US-based minimally invasive ultrasonic medical devices provider, has received 510(k) clearance from the US Food and…