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Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027 FDA posts a Class I recall of Medtronic's Bravo CF delivery device after 184 serious injuries FDA approves Abbott's Aveir VR Mini, 14 percent shorter than the current Aveir VR Mayo Clinic and Thermo Fisher launch Precure to build a million-specimen molecular dataset FDA opens a reliance portal so foreign regulators can lean on its device decisions Medtronic offers a 7 percent discount to push 80.1% of MiniMed onto its own shareholders Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027 FDA posts a Class I recall of Medtronic's Bravo CF delivery device after 184 serious injuries FDA approves Abbott's Aveir VR Mini, 14 percent shorter than the current Aveir VR Mayo Clinic and Thermo Fisher launch Precure to build a million-specimen molecular dataset FDA opens a reliance portal so foreign regulators can lean on its device decisions Medtronic offers a 7 percent discount to push 80.1% of MiniMed onto its own shareholders

The Directory / Imaging & Radiology

Harrison.ai

Sydney, Australia · Series C · 510(k) cleared

Australian medical AI company behind the Annalise radiology decision-support tools for chest X-ray, CT brain and CT chest, and the Franklin.ai pathology platform.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Mar 3, 26	K253818510(k)	Annalise Enterprise	Harrison-AI Medical Pty, Ltd.	Radiology	QAS

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Harrison.ai

FDA DECISIONS ON FILE

COVERAGE