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

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Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA only partly recognizes the 2025 biocompatibility standard and skips clause 6.9 ARPA-H commits $62.7M to autonomous heart failure AI and wants FDA packages in two years Stryker puts the March cyberattack at about $45M of Q3 sales 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 Nvidia takes its first equity stake in Verily Bausch + Lomb wins a CE mark for the SeeLyra femtosecond laser Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA only partly recognizes the 2025 biocompatibility standard and skips clause 6.9 ARPA-H commits $62.7M to autonomous heart failure AI and wants FDA packages in two years Stryker puts the March cyberattack at about $45M of Q3 sales 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 Nvidia takes its first equity stake in Verily Bausch + Lomb wins a CE mark for the SeeLyra femtosecond laser

The Directory / Cardiovascular

Cardiovascular

Shape Memory Medical

San Jose, CA · Unknown · 510(k) cleared

Makes the IMPEDE family of embolization plugs, shape memory polymer devices that are crimped for catheter delivery and self expand when they contact blood.

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