Carlsmed, Inc. news

CARLSBAD, Calif.--(BUSINESS WIRE)--Carlsmed, Inc., announced today the U.S. launch of the aprevo® patient-specific spine technology and the New Technology Add-On Payment (NTAP) reimbursement.

“We are grateful for our surgeon partners that worked with the company early on to develop a truly personalized solution for patients and to collect the clinical data for improved outcomes,” said Mike Cordonnier

CARLSBAD, Calif.--(BUSINESS WIRE)--Carlsmed announced today that aprevo® has been recognized by Orthopedics This Week with the prestigious Spine Technology Award. This award was presented at a ceremony today at the North American Spine Society (NASS) meeting in Boston. The award is given annually to exemplary and innovative spine surgery products that improve spine care, as judged by a panel that includes leading spine

CARLSBAD, Calif.--(BUSINESS WIRE)--Carlsmed, Inc., a commercial stage medical device technology company, is announcing today that it has partnered with the International Spine Study Group Foundation (ISSGF), the premier study group on adult spinal deformity, to collect data on surgical treatment with personalized interbody devices. Long term outcomes data will be collected to assess the role of aprevo® devices in improv

SAN DIEGO--(BUSINESS WIRE)--Carlsmed, Inc., today announced it has been granted 510(k) clearance and Breakthrough Device Designation by the FDA for itsaprevo patient specific interbody devices for the correction of adult spinal deformity. The Carlsmedaprevo device is the first implant ever to receive both Breakthrough Device Designation and 510(k) market clearance from the FDA.

To meet the designation criteria, FDA