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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Directory / Neurology & Neurotech

Neurology & Neurotech Rehab & Mobility

ONWARD Medical

Eindhoven, Netherlands · Public · De Novo granted

Dutch neurotechnology company whose ARC-EX system delivers non-invasive spinal cord stimulation to people with chronic spinal cord injury. It is also developing the implanted ARC-IM and ARC-BCI platforms.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Nov 14, 25	K251821510(k)	ARC-EX System	Onward Medical, Inc.	Physical Medicine	SDO

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ONWARD Medical

FDA DECISIONS ON FILE

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