Regulatory

AMDT Holdings, Inc. Gains FDA Clearance for the SixFix™ System

COLLIERVILLE, Tenn., Sept. 5, 2018 /PRNewswire/ -- AMDT Holdings, Inc. (AMDT) is pleased to announce FDA clearance for their patented SixFix deformity analysis and correction software and instrumentation. AMDT Holdings, Inc. develops new products to address the existing and emerging needs of the multi-billion-dollar extremity medical device market. Spatial frame fixators usually consist of two rings connected

By |2018-09-14T18:24:57+00:00September 14th, 2018|Extremities, Regulatory|

CoreLink Surgical, LLC, Today Announced 510(k) Clearance to Market the M3™ Stand-Alone Anterior Lumbar (ALIF) System

September 11, 2018 ST. LOUIS--(BUSINESS WIRE)--CoreLink Surgical, LLC, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the M3™ Stand-Alone Anterior Lumbar (ALIF) System. Jay Bartling, CEO, said, "M3 is our first stand-alone interbody fusion device to feature 3D printing - I continue to be impressed by the ability of our

By |2018-09-11T18:27:57+00:00September 11th, 2018|Regulatory, Spine|

Captiva Spine Announces TowerLOX-EXT® MIS Extended Tab Pedicle Screw Receives Clearance

Jupiter, FL, September 2018 – Captiva Spine, Inc., which designs, manufactures and distributes elegant and intuitive spine fusion solutions announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market TowerLOX-EXT® MIS Extended Tab Pedicle Screw complementing its TowerLOX® MIS Pedicle Screw System. TowerLOX-EXT MIS Extended Tab Pedicle Screw

By |2018-09-11T17:25:55+00:00September 11th, 2018|Regulatory, Spine, Top Stories|

Amedica Announces Filing of Key Patent Application Relating to the Anti-Viral Effect of its Silicon Nitride

SALT LAKE CITY, Sept. 10, 2018 (GLOBE NEWSWIRE) -- Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, today announced the filing of a U.S. patent application for breakthrough research findings that have identified a new property of its proprietary silicon nitride. Amedica investigators led by Dr. Giuseppe Pezzotti,

By |2018-09-10T14:38:43+00:00September 10th, 2018|Regulatory, Top Stories|

Mandatory joint pay model slashes spending in just eight months

By Virgil Dickson  | September 6, 2018 A mandatory pay model aimed at reducing Medicare spending on joint replacement surgeries was able to save money in its first year. The CMS in recent years has scaled back and canceled mandatory models. Under the Comprehensive Care for Joint Replacement program, average total payments decreased by 3.9% or $1,127 compared

By |2018-09-07T18:48:39+00:00September 7th, 2018|Regulatory|

Hospitals Prepare To Launch Their Own Drug Company To Fight High Prices And Shortages

September 6, 2018 / ALISON KODJAK Sometimes IV bags are hard for hospitals to come by. Other times it's injectable folic acid to treat anemias. Right now, the tissue-numbing agent lidocaine is in short supply. Shortages of commonplace generic drugs have plagued hospitals in recent years. And with short supplies and fewer suppliers for key drugs, there have been

By |2018-09-07T15:58:50+00:00September 7th, 2018|Regulatory|

Baxter Announces U.S. FDA Clearance of New Bone Graft Substitute, Actifuse Flow

Deerfield, Ill. - September 6, 2018 Baxter International Inc. (NYSE:BAX), a global leader in advancing surgical innovation, today announced U.S. Food and Drug Administration (FDA) clearance of Actifuse Flow Bone Graft Substitute for use in a variety of orthopedic surgical procedures. As the newest addition to Baxter’s growing osteobiologics surgery portfolio, Actifuse Flow offers accelerated bone growth in a

By |2018-09-06T19:51:45+00:00September 6th, 2018|Regulatory|

Captiva Spines’s TirboLOX-L™ Dual Layer Organic Lattice Structure 3D Printed Titanium Lumbar Cages Receive Clearance

Jupiter, FL, August 2018 – Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart, elegant and intuitive spinal fusion solutions. Today, Captiva Spine is announcing it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its TirboLOX-L 3D Printed Titanium Lumbar Cages. TirboLOX-L Titanium

By |2018-09-05T17:08:17+00:00September 5th, 2018|Regulatory, Spine, Top Stories|

FDA Grants Eden Spine 510(K) Clearance for Its Thoraco Lumbar Spine Locking Plate – SPHYNX™

GENEVA, SWITZERLAND (PRWEB) AUGUST 30, 2018 The SPHYNX™ is the ideal complement to Eden Spine proprietary, expandable titanium vertebral body replacement implant with rotatable endplates, the GIZA™ which provides multiple angulation options by simple endplates rotation. The GIZA™ is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumor or

By |2018-08-30T22:53:27+00:00August 30th, 2018|Regulatory, Spine, Top Stories|

Ceterix Orthopaedics Announces FDA Clearance of New Suture Cartridge, Providing Increased Flexibility and Enhanced Options for Surgeons

August 28, 2018 FREMONT, Calif.--(BUSINESS WIRE)--Ceterix® Orthopaedics, Inc., a leader in the development of cutting-edge surgical tools for orthopaedic surgeons, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of an added feature to the NovoStitch® Pro Meniscal Repair System – a size 0 suture cartridge – offering surgeons more options to repair meniscal tears.

By |2018-08-28T15:37:59+00:00August 28th, 2018|Regulatory|