medical device guru

Orthopedics and Spine
Acuitive Technologies Wins FDAClearance for Tendon Interference Screw System
Acuitive Technologies announced last week that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CITREFIX™ Knotless Suture Anchor System with CITREGEN™ material technology, a new generation bioresorbable synthetic polymer. The CITREFIX system...
February 14, 2021
Orthopedics and Spine
Zimmer Biomet Spinning Off Spine & Dental Business
Zimmer Biomet (Formerly Known As Biomet Inc.) Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, announced its intention to spin off the Company’s Spine and Dental businesses to form a new and independent, publicly traded company...
February 7, 2021
Orthopedics and Spine
Locate Bio’s CognitOss Lands FDA Breakthrough Device Designation
Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to CognitOss, currently in development for the treatment of chronic osteomyelitis. The FDA Breakthrough Device...
January 8, 2021
Orthopedics and Spine
Stryker Acquires OrthoSensor, Adds Knee Surgery Sensor Technology to Portfolio
Stryker announced today the acquisition of OrthoSensor, Inc., a privately held company founded in 2007 and headquartered in Dania Beach, FL. OrthoSensor, Inc., is a leader in the digital evolution of musculoskeletal care and sensor technology for total joint replacement....
January 5, 2021
Orthopedics and Spine
Miach Orthopaedics’ ACL Tear Device Granted FDA De Novo Approval
Miach Orthopaedics, Inc., a privately held company dedicated to developing bio-engineered surgical implants for connective tissue repair, today announced that the U.S. Food & Drug Administration has granted the company’s De Novo Request for the Bridge-Enhanced® ACL Repair (BEAR®) Implant, resulting...
December 28, 2020
Orthopedics and Spine
FDA Grants Breakthrough Device Designation for Spiderwort Spinal Cord Technology
Spiderwort Inc., a Canadian medical device company developing innovative biomaterials for regenerative medicine, is pleased to announce that the U.S. Food and Drug Administration (FDA) has designated CelluBridgeTM, Spiderwort’s  Spinal Cord Scaffold Implant, as a “Breakthrough Device”. The FDA Breakthrough Devices program...
November 12, 2020
Orthopedics and Spine
Cerapedics Announces Commercial Launch of i-FACTOR+ Matrix in Canada
Cerapedics, a private ortho-biologics company, today announced the full commercial availability of i-FACTOR+ MATRIX for surgical implantation in Canada. “We are excited to announce that i-FACTOR+ Matrix is now fully available in Canada  through our distributor Surgi-One and can be used in both...
November 5, 2020
Orthopedics and Spine
Stryker Will Divest Total Ankle Business to get FTC Blessing for Wright Medical Acquisition
The Federal Trade Commission will require medical device companies Stryker Corp. and Wright Medical Group N.V. to divest all assets related to Stryker’s total ankle replacements and finger joint implant products to remedy concerns that Stryker’s proposed $4 billion acquisition of Wright...
November 3, 2020
Orthopedics and Spine
IlluminOss Medical Receives FDA Clearance for Use in Femur and Tibia Fractures as a Supplement to Approved Hardware
IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, today announced an expanded U.S. Food and Drug Administration (FDA 510k) clearance for its Photodynamic Bone Stabilization System. The new clearance allows IlluminOss to be used in femur and...
October 29, 2020
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