Regulatory

SpinalCyte, LLC Announces New U.S. Patent

August 28, 2018 HOUSTON--(BUSINESS WIRE)--SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc using Human Dermal Fibroblasts, today announced issuance of U.S. Patent No. 10,052,410, “Methods and Compositions For Repair Of Cartilage Using An In Vivo Bioreactor.” The technology described in the patent involves an in vivobioreactor which acts as a delivery system

By |2018-08-28T15:13:26+00:00August 28th, 2018|Regulatory|

Caldwell Cassady & Curry Helps Acantha Win $8.2 Million Patent Infringement Verdict Against Medical Device Giant DePuy Synthes

GREEN BAY, Wisc., Aug. 23, 2018 /PRNewswire/ -- The Dallas-based intellectual property and business litigation law firm Caldwell Cassady & Curry has won an $8.2 million patent infringement verdict for Acantha LLC against medical device manufacturer DePuy Synthes, a subsidiary of health care giant Johnson & Johnson (NYSE : JNJ ). A jury of five women and three men issued the unanimous

By |2018-08-24T15:56:16+00:00August 24th, 2018|Regulatory|

Osseus Fusion Systems’ new family of 3D printed titanium spine implants receives FDA approval

by Sam Davies / 22 August 2018 A Texan medical device company has received FDA approval for five new spinal implants 3D printed in titanium. The family of five FDA 510(k)-cleared lumbar interbody fusion devices is being brought to market by Osseus Fusion Systems under the brand name, Aries. Osseus has been working to develop advanced technology products to enable minimally invasive surgery since it

By |2018-08-22T15:53:30+00:00August 22nd, 2018|Regulatory, Spine|

AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan

17 August 2018 | By Ana Mulero  In a comment submitted on the US Food and Drug Administration’s (FDA) recent action plan to promote medical device safety, the Advanced Medical Technology Association (AdvaMed) raised several concerns with the merit and logistics of the proposal. The five-pronged action plan—revealed in April—consists of establishing a medical device safety net,

By |2018-08-17T22:12:59+00:00August 17th, 2018|Regulatory|

KFx Medical, LLC. Sues Stryker, Inc. for Patent Infringement

August 16, 2018 SAN DIEGO--(BUSINESS WIRE)--KFx Medical, LLC. announced it has sued Stryker, Inc. (NYSE: SYK) for its continued infringement of US Patent number 7,585,311 and related patents for knotless double row rotator cuff repair. In 2015, when KFx successfully defended these patents versus Arthrex, Inc., Arthrex paid in excess of $35m in damages and

By |2018-08-17T16:20:34+00:00August 17th, 2018|Regulatory|

CoreLink, LLC Announces 510(k) Clearance for Foundation™ 3D Anterior Lumbar (ALIF)

August 16, 2018 ST. LOUIS--(BUSINESS WIRE)--CoreLink, LLC, a vertically integrated manufacturer of spinal implant systems, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market The FoundationTM 3D Anterior Lumbar (ALIF) Interbody device. This marks the launch of the latest addition to CoreLink’s Foundation 3D Interbody Cage family. Jay Bartling, CEO, said,

By |2018-08-16T17:30:46+00:00August 16th, 2018|Regulatory, Spine|

MiMedx Receives Regulatory Approval to Commercialize Product Portfolio in Australia

MARIETTA, Ga., Aug. 9, 2018 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that it received regulatory approval from the Therapeutics Goods Administration (TGA) in Australia to market and sell a broad array of the Company's dehydrated Human Amnion/Chorion Membrane (dHACM) products. This includes EpiFix®, AmnioFix®, EpiBurn®, AmnioFix Injectable, and

By |2018-08-09T15:47:29+00:00August 9th, 2018|Regulatory|