medical device guru

Orthopedics and Spine
Cerapedics Announces Canadian Approval of its Next-generation Bone Graft
Cerapedics, a private ortho-biologics company, today announced the Health Canada approval of the company’s next-generation bone graft called i-FACTOR+ Matrix, making it the first market to approve the commercial launch of this product. “We are excited to announce Canadian regulatory...
September 17, 2020
Orthopedics and Spine
FDA Clears SurGenTec Synthetic Bone Graft
SurGenTec, a privately held spine and orthopedic technology company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary OsteoFlo NanoPutty- Quadphasic Synthetic Bone Graft. OsteoFlo NanoPutty is a novel bone...
August 27, 2020
Orthopedics and Spine
FDA Clears Life Spine Anterior Lumbar Spacer System
Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the PLATEAU-A Ti...
August 6, 2020
Orthopedics and Spine
FX Solutions Receives FDA 510k Clearances for Titanium Nitride Coated Humeral Heads and Glenospheres
FX received 510k clearances for their TiN (Titanium Nitride) Coated Humeral Heads and Glenospheres. The new addition of TiN coated humeral heads and glenospheres adds unique-to-market prostheses to the FX portfolio. The TiN coated humeral heads and glenospheres are identical to the current...
July 20, 2020
Orthopedics and Spine
Mayo Clinic performs first shoulder arthroplasty with Wright Medical mixed reality tech
Wright Medical Group N.V. (NASDAQ: WMGI) today announced that the first shoulder arthroplasty procedure was performed using groundbreaking BLUEPRINT Mixed Reality Technology at Mayo Clinic’s campus in Rochester, Minnesota.  Joaquin Sanchez-Sotelo, M.D., Ph.D, performed the procedure utilizing BLUEPRINT OR Visualization Mixed Reality software, which provides...
July 17, 2020
Orthopedics and Spine
Medtronic to Acquire Medicrea
Medtronic plc (NYSE:MDT), a global leader in medical technology, and Medicrea, a pioneer in the transformation of spinal surgery through artificial intelligence, predictive modeling and patient specific implants, today announced that they have entered into a tender offer agreement for...
July 15, 2020
Orthopedics and Spine
4WEB Medical Announces FDA 510(k) Clearance of Stand-Alone Anterior Lumbar Interbody Fusion Device
4WEB Medical, an orthopedic device company focused on developing innovative implants with an Advanced Structural Design that utilizes its proprietary Truss Implant Technology™, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to...
June 10, 2020
Orthopedics and Spine
GTX medical Granted FDA Breakthrough Device Designation for Go-2 Targeted Epidural Spinal Stimulation (TESS) System
GTX medical (GTX), today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its implantable Go-2 system which was designed to promote the recovery of leg motor functions and neurological control in adults with...
June 9, 2020
Orthopedics and Spine
Centinel Spine Announces FDA Approval for the Manufacturing Transfer of prodisc Technology
Centinel Spine, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced FDA approval for the manufacturing transfer of both the prodisc® C Cervical Total Disc Replacement and prodisc® L Lumbar Total Disc Replacement systems to new strategic vendors. The FDA...
May 27, 2020
1 2 3 16