MedTech News

Respiree secures FDA 510(k) extension for cardio-respiratory wearable
The RS001 chest-worn device directly measures respiration and provides passive cardio-respiratory monitoring.

Body Vision Medical Secures HSA Approval for AI-Powered LungVision Platform in Singapore
Regulatory green light marks full commercial launch of LungVision, enhancing early lung cancer detection through AI-driven 3D imaging for more precise bronchoscopic diagnostics.

Bracco Imaging’s SonoVue® Secures NMPA Approval for HyCoSy Use in China, Enhancing Non-Invasive Infertility Diagnostics
Regulatory milestone supports China’s reproductive health goals by enabling radiation-free, high-accuracy ultrasound imaging to assess fallopian tube patency and uterine abnormalities in women.

Deep learning model predicts microsatellite instability in tumors and flags uncertain cases
One in every three people is expected to have cancer in their lifetime, making it a major health concern for mankind. A crucial indicator of the outcome of cancer is its tumor microsatellite status—whether it is stable or unstable. It refers to how stable the DNA is in tumors with respect to the number of mutations within microsatellites.

Stem cells created from ALS patients point to potential new target for treatment
Amyotrophic lateral sclerosis (ALS), known as Lou Gehrig’s disease, is an incurable neurological disorder affecting motor neurons—nerve cells in the brain and spinal cord that control voluntary muscle movement and breathing.

New technique uses focused sound waves and holograms to control brain circuits
A new study provides the first visual evidence showing that brain circuits in living animals can be activated by ultrasound waves projected into specific patterns (holograms).

BMI OrganBank Secures FDA Breakthrough Device Designation for Innovative Kidney Transplant Technology
BMI OrganBank is developing novel medical devices with potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys

TransMedics gets FDA green light to begin next-gen heart perfusion trial
TransMedics (Nasdaq:TMDX) announced today that the FDA says it can proceed with the initiation of a trial for its OCS Heart System.