Medtronic secures CE mark for Stealth AXiS system for ENT surgery
The Stealth AXiS system is designed to assist surgeons in navigating both basic and complex sinus and skull base anatomies.
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Women’s health apps: governance and transparency key to success as opportunities bloom
Experts say that prioritising data privacy and governance, while focusing on proactive regulatory interactions, can help developers make a success…
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Medtronic secures CE mark for Stealth AXiS system for ENT surgery
The Stealth AXiS system is designed to assist surgeons in navigating both basic and complex sinus and skull base anatomies.
Women’s health apps: governance and transparency key to success as opportunities bloom
Experts say that prioritising data privacy and governance, while focusing on proactive regulatory interactions, can help developers make a success…
FDA issues early alert for GE HealthCare’s infant resuscitation systems
The alert relates to a potential issue with certain blenders that mix air and oxygen to deliver controlled oxygen concentration.
ADA26: Dexcom’s G7 CGM helps TD2 diabetics not on insulin manage glucose levels
Dexcom anticipates that the findings could drive a shift in the standard of care for type 2 diabetes patients who…
Tandem secures CE mark for AID systems in T2D and T1D with pregnancy
The regulatory clearance covers the t:slim X2 and Tandem Mobi insulin pumps with Control-IQ+ technology.
Insulet reports new data for Omnipod 6 and FCL systems
Findings from the STRIVE study indicated improved glycaemic control with Omnipod 6 compared to Omnipod 5.
Zepto Life Technology’s mould infection panel obtains FDA breakthrough designation
Zepto Life’s FungiFlex mould panel is designed to identify 14 clinically important mould species based on cell free fungal DNA…
Sophia Genetics and MSK join forces to develop precision oncology hub
The entities intend for their latest pair-up to progress new approaches to multimodal precision oncology.
Roche develops RUO PCR assay to detect rare Ebola Bundibugyo virus
TIB MOLBIOL developed the test using its "rapid response" library, with 15,000 designs and 3,000 controls.
FDA approves GE HealthCare’s MIM Contour ProtégéAI+ 2.0 software
The tool aims to reduce planning time and help care teams create more tailored strategies.
