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While Shield, Guardant’s blood-based colorectal cancer screening test, got an overall thumbs-up from an FDA advisory committee, members stressed that it’s no substitute for colonoscopy. Read More
In this edition of Quick Notes, the FDA clears an endoscopic camera capsule for home use, some of GE Healthcare’s ultrasound imaging software shows cyberattack vulnerability, and the FDA clears self-collection of vaginal swabs for HPV testing, and OKs a new cardiac cath guidewire. Read More
A patient-reported outcome instrument that assesses vision symptoms before and after intraocular lens implant surgery is now a part of the Medical Device Development Tools (MDDT) program.
This edition of Quick Notes reviews the FDA’s 510(k) clearance of Outset Medical’s TabloCart as well as perfusion imaging analysis by RapidAI and an OTC version of the Masimo Stork baby monitor. FDA approval was granted to Genescopy’s ColoSense. Read More
This edition of Quick Notes reviews the FDA’s 510(k) clearance of a ZygoFix spinal fusion device, GE Healthcare’s vital signs monitor, an EEG monitoring system and AI for event detection by Epitel, and BMF cosmetic dental veneers. Read More
This edition of Quick Notes reviews the FDA’s approval of Medtronic’s closed-loop rechargeable spinal cord stimulator, Abbott’s below the knee Everolimus Eluting Resorbable Scaffold System, an integrated continuous glucose monitor, and clearance of AEYE Health’s AI that diagnoses referable diabetic retinopathy. Read More
This edition of Quick Notes looks at FDA clearances and classifications for devices involving cranial implants, Parkinson’s Disease symptoms, at-home blood sampling and robotic microsurgery. Read More