Notable regulatory greenlights 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, robotics and other innovative technologies changing healthcare delivery.
Radiobiotics: FDA clearance for knee osteoarthritis AI (Aug. 30)
Asensus Surgical: FDA clearance for expanded machine vision capabilities on previously cleared surgical platform (Sept. 1)
EndoSound: FDA breakthrough designation for endoscopic video-to-ultrasound converter (Sept. 1)
In2Bones: FDA clearance for 3D-printed ankle bone cutting guides (Sept. 1)
MIM Software: CE mark approval for AI molecular radiotherapy dosimetry (Sept. 7)
Madorra: FDA breakthrough designation for women’s health therapeutic ultrasound (Sept. 8)
Novocure: FDA breakthrough designation for tumor-treating electric fields (Sept. 9)
Nyxoah: FDA breakthrough designation for hypoglossal nerve stimulation in obstructive sleep apnea patients (Sept. 14)
Paige.AI: FDA clearance for AI prostate biopsy diagnostics (Sept. 21)
SeaSpine: CE mark approval for 3D image presentation for surgical navigation (Sept. 27)
Zebra Medical Vision: FDA clearance for AI quantification of coronary calcium scoring (Sept. 27)
Novian Health: FDA breakthrough designation for laser destruction of breast malignancies (Sept. 28)
Selex Diagnostics: FDA breakthrough designation for rapid antimicrobial susceptibility testing (Sept. 28)
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.