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THE TAPE

MintNeuro raises 4.4 million euros for chips designed into neural implants iRhythm closes the VitalConnect deal at $287.5M, mostly in cash HeartSciences clears the MyoVista ECG hardware under K260005 without its AI algorithm FDA approves an Abbott update that shows CardioMEMS patients their own pressure readings UK accepts 44 AI commission recommendations and moves to continuous device monitoring Click Therapeutics clears Motivista for the negative symptoms of schizophrenia NeuWire Medical wins an IDE for a 135-patient trial of battery-free vagus nerve stimulation GE HealthCare pays $945M cash for Sofie Biosciences and 15 PET manufacturing sites Zenflow raises $52M and hands Cook Medical US distribution for the Spring implant MintNeuro raises 4.4 million euros for chips designed into neural implants iRhythm closes the VitalConnect deal at $287.5M, mostly in cash HeartSciences clears the MyoVista ECG hardware under K260005 without its AI algorithm FDA approves an Abbott update that shows CardioMEMS patients their own pressure readings UK accepts 44 AI commission recommendations and moves to continuous device monitoring Click Therapeutics clears Motivista for the negative symptoms of schizophrenia NeuWire Medical wins an IDE for a 135-patient trial of battery-free vagus nerve stimulation GE HealthCare pays $945M cash for Sofie Biosciences and 15 PET manufacturing sites Zenflow raises $52M and hands Cook Medical US distribution for the Spring implant

FDA Approval

FDA approves an Abbott update that shows CardioMEMS patients their own pressure readings

MedDevice Startups Staff · 23 hrs ago · 2 min read · Via Fierce Biotech

FDA approved new software for Abbott's CardioMEMS HF System on October 6. The CardioGuide HF app shows pulmonary artery pressure readings on a patient's smartphone. Until now those readings went only to the care team.

The same approval covers Dynamic Treatment Plan, which lets a clinician set personalized medication adjustment protocols tied to pressure changes. Abbott plans to launch both later in 2026. The implant itself does not change. It is still a catheter-delivered sensor in the pulmonary artery, used for more than a decade to catch worsening heart failure weeks before symptoms appear.

No hardware moved here, so the review work sat in labeling and human factors. Handing a patient a number that was clinician-only changes who acts on it, and that is the question FDA had to be satisfied on.

Questions & Answers

What did FDA approve for Abbott's CardioMEMS HF System?

On October 6, 2026 FDA approved updated software for Abbott's CardioMEMS HF System. It adds the CardioGuide HF app, which shows patients their own pulmonary artery pressure readings, and a Dynamic Treatment Plan feature for clinician-set medication protocols.

When will Abbott launch the CardioGuide HF app?

Abbott plans to launch the CardioGuide HF app and the Dynamic Treatment Plan features later in 2026, following the October 6, 2026 FDA approval.

Does the CardioMEMS implant change with this approval?

No. The October 6, 2026 approval covers software only. The CardioMEMS sensor is still a catheter-delivered implant placed in the pulmonary artery.

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