MedTech News
.................... by Andrew Celentano
Waters Announces FDA 510(k) Clearance of BD BACTEC FXI Culture System, Enabling Broader Access to Bloodstream Infection Diagnostics
MILFORD, Mass., June 3, 2026 /PRNewswire/ — Waters Corporation (NYSE: WAT) today announced that the BD BACTEC FXI Culture System has received U.S. Food and Drug Administration (FDA) 510(k) clearance.
Reach Surgical Receives CE Mark Approval for SOUND REACH™ Swift
SINGAPORE, June 3, 2026 /PRNewswire/ — Reach Surgical, the surgical solutions division of Genesis MedTech, has received CE Mark approval for SOUND REACHTM Swift, ultrasonic shears designed for open surgical procedures, including breast and thyroid surgeries.
FDA Clears Clarius Ejection Fraction AI for Automated Cardiac Ultrasound Assessments
Clarius Mobile Health announced FDA clearance for its Ejection Fraction AI, an intelligent cardiac assessment tool integrated directly into the Clarius ultrasound app.
A new vaccine adjuvant could make it easier to eradicate polio
The adjuvant can help the injectable polio vaccine induce a strong immune response in the GI tract, which is considered critical to eradicating the virus.
Real-time brain monitor detects infections earlier
The result is NeuroSense, a monitoring system that connects to drainage lines to detect biomarkers of infection, including changes in glucose, lactate and pH, as well as flow rate, as brain fluid moves through them.
AI helps accelerate breast cancer diagnosis for high-risk women
Researchers used an open-source AI model called Mirai, which was developed by the study’s senior author, UC Berkeley data scientist Adam Yala, Ph.D.
Custom 4D-printed implants offer less painful path to tissue reconstruction
Di Wang, Ph.D., and Y. Shrike Zhang, Ph.D., of the Division of Engineering in the Mass General Brigham Department of Medicine, the lead and senior authors of the study published in Nature Biomedical Engineering, developed a special gel-like material whose expansion speed and final size can be carefully controlled. The paper is titled “4D-printed adaptive hydrogel tissue expanders for ear and breast reconstruction.”
Ultrasound-based pacemaker noninvasively steadies the heart
MIT engineers have developed a noninvasive pacemaker that stimulates the heart using ultrasound. The design could one day provide a surgery-free alternative to traditional cardiac implants.