WHERE ARE YOU?

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

THE TAPE

Boston Scientific says plants and shipping are fully back 17 days after the cyberattack ARPA-H commits $62.7M to autonomous heart failure AI and wants FDA packages in two years Glucotrack raises $11.5M in convertible notes at a 22 percent original issue discount Cardiovascular AI notification software gets its own Class II regulation and a 510(k) path CMS covers TAVR for asymptomatic patients and drops the evidence requirement for symptomatic ones FDA codifies eight De Novo device types as Class II, three years after granting them Axogen to pay $200M cash for BioCircuit and its sutureless NerveTape Nutromics wins Breakthrough designation for a microneedle patch that reads vancomycin levels Precera Medical buys Additive Metal Services to bring metal injection molding in house Boston Scientific says plants and shipping are fully back 17 days after the cyberattack ARPA-H commits $62.7M to autonomous heart failure AI and wants FDA packages in two years Glucotrack raises $11.5M in convertible notes at a 22 percent original issue discount Cardiovascular AI notification software gets its own Class II regulation and a 510(k) path CMS covers TAVR for asymptomatic patients and drops the evidence requirement for symptomatic ones FDA codifies eight De Novo device types as Class II, three years after granting them Axogen to pay $200M cash for BioCircuit and its sutureless NerveTape Nutromics wins Breakthrough designation for a microneedle patch that reads vancomycin levels Precera Medical buys Additive Metal Services to bring metal injection molding in house

The Directory / Cardiovascular

Cardiovascular

InVera Medical

Galway, Ireland · Seed · 510(k) cleared

Makes the InVera Infusion Device, a 5Fr catheter with a helical coil that delivers sclerosants into diseased leg veins without heat. Spun out of the BioInnovate Ireland program and formerly named Venari Medical.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Mar 12, 26	K250794510(k)	InVera Infusion Device	Invera Medical	Cardiovascular	KRA

← More Cardiovascular startups