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

THE TAPE

Laza Medical raises up to $160M in a Series B led by GE HealthCare Evident Vascular clears its IVUS guidance system for peripheral procedures GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework Neurotronics clears a sleep time algorithm that reads a pulse oximeter signal BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Lincoln Ventures agrees to buy Aegis Medical in an all-stock reverse takeover FDA adds kidney disease and diabetes data to the Symplicity Spyral label Laza Medical raises up to $160M in a Series B led by GE HealthCare Evident Vascular clears its IVUS guidance system for peripheral procedures GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework Neurotronics clears a sleep time algorithm that reads a pulse oximeter signal BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Lincoln Ventures agrees to buy Aegis Medical in an all-stock reverse takeover FDA adds kidney disease and diabetes data to the Symplicity Spyral label

The Directory / Cardiovascular

PulseAI

Belfast, Northern Ireland · Seed · 510(k) cleared

Builds cloud AI models that interpret single-lead ECG recordings from wearables, patches and hospital monitors. It licenses the models to device makers rather than selling direct to consumers.

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PulseAI

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