
Zeiss’ AI-driven tool gets CE mark for OCT scans
The CIRRUS PathFinder tool is available via licensing in the new software update.

The CIRRUS PathFinder tool is available via licensing in the new software update.

PERTH, Australia, Aug. 21, 2025 /PRNewswire/ — Artrya Limited (ASX: AYA) (Artrya or the Company), a medical technology company commercialising its Salix® AI-powered cloud platform, for the near real time, point of care assessment and management of coronary artery disease, is pleased to announce it has received 510(k) clearance from the U.S. Food and Drug Administration (the FDA) for Artrya’s proprietary, Salix® Coronary Plaque module.

Cepheid announced that the test will be shipped to Canadian customers this month.

Signos today announced a major step forward in bringing over-the-counter (OTC) continuous glucose monitoring (CGM) to market.

Microbot Medical (Nasdaq:MBOT) announced today that it received a new patent covering a modular robotic surgical system.

Masimo (Nasdaq: MASI)+
 announced today that it received FDA 510(k) clearance for expanded indications for its O3 regional oximetry technology

Tandem Diabetes Care (Nasdaq:TNDM) has a new infusion set on the way to pair with its insulin delivery offerings.

ANKARA, Türkiye, Aug. 18, 2025 /PRNewswire/ — Nerveblox, an AI software solution by SmartAlpha, designed to assist physicians in using ultrasound while administering regional anesthesia procedures commonly known as ‘nerve blocks’, has received U.S. Food and Drug Administration (FDA) 510(k) clearance.

The company is collaborating with local companies and healthcare providers to distribute the ulcer test.

NeuroOne (Nasdaq:NMTC) announced today that it received FDA clearance for its OneRF trigeminal nerve ablation system.