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

THE TAPE

BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power Surmodics buys Alta Biomed for its PzF coating and a Carlsbad blood loop lab FDA names the first five companies in its READI-Home readmissions program CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first Edwards wins FDA approval for a pulmonary valve that expands from 13 mm to 22 mm Medtronic wins a Category I CPT code for renal denervation, effective January 2028 Axogen closes the BioCircuit deal and puts $34M of 2027 revenue on NerveTape BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power Surmodics buys Alta Biomed for its PzF coating and a Carlsbad blood loop lab FDA names the first five companies in its READI-Home readmissions program CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first Edwards wins FDA approval for a pulmonary valve that expands from 13 mm to 22 mm Medtronic wins a Category I CPT code for renal denervation, effective January 2028 Axogen closes the BioCircuit deal and puts $34M of 2027 revenue on NerveTape

The Directory / Cardiovascular

Hilo

Neuchatel, Switzerland · Series B · 510(k) cleared

Builds a cuffless blood pressure wearable that estimates pressure from optical signals at the wrist, calibrated by a connected upper-arm cuff. Sold as a membership with a band, an app and the cuff.

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