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

FDA Approves Gilead’s Trodelvy, Alone and With Merck’s Keytruda, in First-Line Metastatic TNBC
Decision delivers the first ADC-based regimens for previously untreated triple-negative breast cancer across PD-L1 status, a PD-L1-positive Keytruda combination plus a monotherapy option for immunotherapy-ineligible patients.

A Noninvasive Way to Monitor Babies’ Health
A tiny silk sticker that visibly shows vital health signals, read by an AI system, could change how we care for the tiniest patients

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.