Notable regulatory approvals of emerging technologies over the past 30 days
Along with AI in its various iterations, the list may include virtual and augmented reality, 3D printing and visualization, robotics and other innovative technologies changing healthcare delivery.
Claritas HealthTech: FDA clearance for AI medical image enhancement (Oct. 26)
Samsung NeuroLogica: FDA clearance for AI nodule detection on lung X-rays (Oct. 28)
Clever Culture Systems: FDA clearance for AI rule-out of MRSA on pathology cultures (Oct. 29)
Predictmedix: CE certification for AI walk-through disease screening (Nov. 2)
MIM Software: FDA clearance for AI radiotherapy contouring (Nov. 3) and AI tumor segmentation and dosimetry (Nov. 17)
ReWalk Robotics: FDA breakthrough designation for orthotic exo-suit (Nov. 4)
nView Medical: FDA clearance for AI image reconstruction to guide surgery (Nov. 5)
HeartVista: FDA clearance for AI one-click cardiac MRI (Nov. 10)
GE Healthcare: AI endotracheal tube guidance (Nov. 15)
Lunit: FDA clearance for AI chest X-ray triage (Nov. 15) and AI breast cancer detection (Nov. 18)
Airs Medical: FDA clearance for AI reconstruction of MRI images (Nov. 16)
AppliedVR: FDA clearance for VR back-pain therapy (Nov. 16)
Blackrock Neurotech: FDA breakthrough designation for brain-computer interface in paralysis care (Nov. 16)
Wision AI: CE certification for AI colonoscopy polyp detection (Nov. 17)
Strados Labs: CE certification for smart respiratory sensor platform (Nov. 18)
Cardiologs: FDA clearance for AI pediatric cardiology platform (Nov. 22)
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.