The U.S. Food and Drug Administration's Center for Devices and Radiological Health made the CDRH eSubmissions Pilot Program available and has expanded it to include more participants.

Published in Orthopedic

MindwaysCT received 510(k) clearance from the U.S. Food and Drug Administration to market its quantitative computed tomography calibration technology for CT-based bone mineral density measurement.

Published in Orthopedic

The Food and Drug Administration cleared 37 orthopedic- and spine-related devices in September.

Published in Orthopedic

Dallen Medical announced the first human use of its Compressyn Staple, a rigid compression fixation technology that delivers continuous compression for small bone fixation.

Published in Orthopedic
Monday, 04 August 2014 00:00

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September 11, 2013: Spine Business
Top 7 Lists: 15 News Updates for Spine & Orthopedic Device Companies | 30 Spine Surgeons Leading Fellowship Programs | 49 Cleanest Hospitals in the US | Seeking 2 Spine Surgeon Conf. Panelists |

Published in Uncategorized

DoctorThe Food and Drug Administration granted 31 spine- and orthopedic-related medical device clearances in July.

InstrumentsThe Food and Drug Administration granted 11 spine-related device clearances in June.

Collegeville, Pa.-based Synergy Biomedical received FDA clearance for its BioSphere Putty for bone grafts.
Aliso Viejo, Calif.-based Vertos Medical has closed a $23 million round of Series E financing to fund the U.S. commercial expansion and European launch of its mild procedure for lumbar spinal stenosis.
Sunrise, Fla.-based OrthoSensor received FDA 510(k) clearance for its VERASENSE knee system, an instrument system for implant position during total knee replacements.
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