WHERE ARE YOU?

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

THE TAPE

Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing VCD Medical clears VEnice, a clip that closes varicose veins without heat Sofinnova closes an 82 million euro fund to start six to eight device companies Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line Insera clears the CLEAR aspiration system for peripheral clot removal under K253404 Webster Equity takes Lifecore Biomedical private at $6.28 a share plus CVRs Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing VCD Medical clears VEnice, a clip that closes varicose veins without heat Sofinnova closes an 82 million euro fund to start six to eight device companies Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line Insera clears the CLEAR aspiration system for peripheral clot removal under K253404 Webster Equity takes Lifecore Biomedical private at $6.28 a share plus CVRs

The Directory / Respiratory & Sleep

Wellinks

New Haven, CT · Series B · 510(k) cleared

Runs the Spire remote patient monitoring system with wearable Health Tags for continuous cardiopulmonary tracking, aimed at catching COPD deterioration before symptoms appear.

← More Respiratory & Sleep startups