MedTech News
.................... by Andrew Celentano

Cyclana Bio granted Health Research Authority approval
Cyclana Bio, a biotechnology company pioneering tissue-level approaches to women’s health, has announced it has received Health Research Authority (HRA) and Research Ethics Committee (REC) approval for its 500-patient clinical observational study, PEMP (Predicting Endometriosis Mechanisms and Populations).

Spotlight Medical lands IVDR CE Mark for AI Breast Cancer Test
Spotlight Medical, a Paris-based oncology diagnostics company, has announced that myStage Dx has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746).

Gut fungi may hold the key to treating asthma worldwide
One paper by Dr. Stuart Turvey and colleagues at BC Children’s Hospital Research Institute (BCCHR) and another paper by Dr. Marie-Claire Arrieta and colleagues from the Snyder Institute for Chronic Diseases and the Alberta Children’s Hospital Research Institute reveal key to treating asthma.

New blood test detects more high-risk prostate cancer cases
In a study from Karolinska Institutet, the Stockholm3 blood test detected more clinically significant cancer cases than the PSA test, without subjecting more men to unnecessary testing.

Faster breast MRI—AI unlocks one image per second and sharper tumor tracking
A group of researchers from the Technion and the United States reports a breakthrough in MRI scanning in a paper published in Nature Communications.

Mini robot simplifies dental treatment by preparing teeth for crowns
Researchers at the University of Basel have developed a miniature dental robot that could one day automatically prepare teeth for crowns. The technology could help reduce the number of appointments needed for dental treatment.

Draeger Receives FDA Clearance for Evita V800 Software Update with New Ventilation Features
Draeger has received FDA 510(k) clearance to market the latest software update for its Evita V800 ventilator. The version 3.10 software release introduces additional features designed to enhance mechanical ventilation for patients with pulmonary conditions, including acute respiratory distress syndrome (ARDS).

PorTal Access Secures FDA Clearance for FLEXI-PORT Vascular Access Ports
The power-injectable implantable port system is designed to support long-term vascular access in adult and paediatric patients.