medical device guru

Orthopedics and Spine
Stryker Installed an Impressive 54 Mako Robots in Q4 2018
Stryker made the market wait for more than a year after FDA approval for the full commercial launch of its Mako total knee product, prompting us to wonder, at the time, if the robot would be worth the wait. It’s safe...
January 31, 2019
Orthopedics and Spine
Medtronic Announces First U.S. Spine Patients Treated with Mazor X Stealth Robotic Surgical System
Medtronic today announced the first U.S. patients treated with the Mazor X Stealth Edition for spine surgery following its recent commercial launch. The Mazor X Stealth Edition offers a fully-integrated procedural solution for surgical planning, workflow, execution and confirmation. The...
January 28, 2019
Orthopedics and Spine
Zimmer Biomet Receives FDA Clearance for ROSA® Knee System for Robotically-Assisted Surgeries
Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® Knee System for robotically-assisted total knee replacement surgeries. ROSA Knee features 3D pre-operative planning tools and real-time, intraoperative data...
January 25, 2019
Orthopedics and Spine
Orchid Orthopedic Solutions Acquired by European Private Equity Firm
Nordic Capital Fund IX announced today that it has agreed to acquire a majority holding in Orchid Orthopedic Solutions, from Altor Fund III who will retain a significant minority holding in the company. Headquartered in Holt, Michigan, Orchid is a world...
January 23, 2019
Orthopedics and Spine
OSSIO Receives 501(k) Clearance for Bio-Integrative Bone Pins
The FDA has granted 510(k) clearance to Ossio for its family of bio-integrative bone pins, which secure broken bones during the healing process while leaving no permanent hardware behind. The pins are made of a natural mineral fiber matrix that...
January 14, 2019
Orthopedics and Spine
Smith & Nephew Buys Ceterix Orthopedics for up to $105M
Smith & Nephew, the global medical technology business, today announces that it has agreed to acquire Ceterix® Orthopaedics, Inc, the developer of the NovoStitch® Pro Meniscal Repair System. This unique device addresses complex meniscal tear patterns not adequately served by other repair systems. It...
December 18, 2018
Orthopedics and Spine
PeekMed Receives FDA 510(k) Clearance for Orthopedic Planning System
PeekMed® reached 510(k) clearance for its orthopedic planning system, from the U.S. Food and Drug Administration (FDA), after regulatory approval in the European Union, and successfully working with more than 1100 surgeons. Developing a product in the medical field is highly demanding when it comes...
December 14, 2018
Orthopedics and Spine
Nexxt Spine Receives 510(k) for Posterior Cervical Spine System
Nexxt Spine has received FDA 510(k) clearance and has commercially launched its Saxxony Posterior Cervical Thoracic System. The system is designed to stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments through posterior screw fixation. “The Saxxony...
December 11, 2018
Orthopedics and Spine
RTI Surgical to Acquire Paradigm Spine for $300M
RTI Surgical, Inc., a global surgical implant company, and Paradigm Spine, LLC, a leader in motion preservation and non-fusion spinal implant technology, today announced that they have entered into a definitive agreement whereby RTI will acquire all outstanding equity interest...
November 2, 2018
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