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Over seven hours of presentations, 50 stakeholders and members of the public voiced their opinions on the FDA’s advisory committee process, focusing often on diversity as well as patient and consumer perspectives in the panels, along with improved transparency and communications. Read More
This edition of Quick Notes offers news on medical devices including two continuous glucose monitoring system clearances for Abbott, cybersecurity vulnerabilities for Baxter Welch Allyn, clearance of an AI solution from Heuron to alert of impending intracranial hemorrhage and clearance of an easy-to-use EEG system from Zeto. Read More
This edition of Quick Notes looks at the FDA clearances for heart monitoring and lung disease diagnostic algorithms, an artificial pancreas app and a bipolar radiofrequency hysteroscopy system. Read More
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