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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 / Cardiovascular

Cardiovascular

Protaryx Medical

Baltimore, MD · Unknown · 510(k) cleared

Baltimore company developing a transseptal puncture device for left-heart access, cleared by FDA in April 2026.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Apr 10, 26	K260839510(k)	Protaryx Transseptal Puncture Device (PTX2-001)	Protaryx Medical, Inc.	Cardiovascular	DYB

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