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…
How AI-powered tools in pharma are benefiting clinical and commercial operations
AI in pharma can automate parts of the clinical processes by gaining insight into data such as recommending…
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…
How nCipher Security recommends hospitals can stay resilient to cyber-threats
We speak to John Grimm from nCipher Security on how hospitals can prepare for new vulnerabilities