Regulatory

Lamar Alexander and Patty Murray announce bipartisan Senate deal to prop up Obamacare
Regulatory Top Stories

Lamar Alexander and Patty Murray announce bipartisan Senate deal to prop up Obamacare

Deborah Barfield Berry, USA TODAY/October 17, 2017 WASHINGTON — Democratic and Republican leaders in the Senate announced they have reached a bipartisan deal to shore up the Affordable Care Act health insurance markets for two years while Congress continues to grapple with GOP efforts to replace the law. Sens. Lamar Alexander, […]

MiMedx Notified By FDA That It Can Proceed With Phase 2B Investigational New Drug Clinical Trial For Osteoarthritis Of The Knee
Biologics Regulatory Top Stories

MiMedx Notified By FDA That It Can Proceed With Phase 2B Investigational New Drug Clinical Trial For Osteoarthritis Of The Knee

MARIETTA, Ga., Oct. 17, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has been notified by the Food and Drug Administration (FDA) that […]

TransEnterix Announces US 510(k) FDA Clearance for Senhance Surgical Robotic System
Regulatory Robotics Top Stories

TransEnterix Announces US 510(k) FDA Clearance for Senhance Surgical Robotic System

October 13, 2017 RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced the Company has received FDA 510(k) clearance for the Senhance™ Surgical Robotic System. “The clearance of the Senhance System in […]

Anika Announces Regulatory Approval for MONOVISC® in Australia
Extremities Regulatory

Anika Announces Regulatory Approval for MONOVISC® in Australia

October 16, 2017 BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that regulatory authorities in Australia granted approval to MONOVISC®, Anika’s single injection viscosupplement for the treatment of pain associated with osteoarthritis of all […]

NuVasive Receives Expanded FDA 510(k) Clearance For TLX Interbody System Used In TLIF Procedures
Regulatory Spine

NuVasive Receives Expanded FDA 510(k) Clearance For TLX Interbody System Used In TLIF Procedures

SAN DIEGO, Oct. 16, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced an expanded U.S. Food and Drug Administration (FDA) 510(k) clearance of the Company’s TLX interbody system, used in the leading spinal fusion surgery. New clearance […]

Stryker Receives FDA Clearance for Cementless Mako Total Knee with Triathlon® Tritanium®
Recon Regulatory Robotics Top Stories

Stryker Receives FDA Clearance for Cementless Mako Total Knee with Triathlon® Tritanium®

MAHWAH, N.J., Oct. 16, 2017 /PRNewswire/ — Stryker’s Joint Replacement division today announced that its cementless Mako Total Knee with Triathlon Tritanium has received 510(k) market clearance by the U.S. Food and Drug Administration. Triathlon Tritanium combines the kinematics of Stryker’s market leading Triathlon knee implant with the latest in highly porous […]

NuVasive Receives Expanded FDA 510(k) Clearance For Innovative Magnetic Limb Lengthening Technology
Regulatory

NuVasive Receives Expanded FDA 510(k) Clearance For Innovative Magnetic Limb Lengthening Technology

SAN DIEGO, Oct. 12, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received expanded 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s PRECICE® system from NuVasive Specialized Orthopedics™ […]

Nuvasive Files Lawsuit Against Patrick S. Miles To Protect Corporate Assets And Stakeholders’ Interests
Regulatory Spine Top Stories

Nuvasive Files Lawsuit Against Patrick S. Miles To Protect Corporate Assets And Stakeholders’ Interests

SAN DIEGO, Oct. 10, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has filed a lawsuit in the Delaware Chancery Court against Patrick S. Miles, former vice chairman of the Company and a member of NuVasive’s Board […]

Flexion Therapeutics Announces FDA Approval of Zilretta™ for Osteoarthritis (OA) Knee Pain
Regulatory

Flexion Therapeutics Announces FDA Approval of Zilretta™ for Osteoarthritis (OA) Knee Pain

BURLINGTON, Mass., Oct. 06, 2017 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Food and Drug Administration (FDA) approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular injection for osteoarthritis knee pain. Zilretta is a non-opioid medicine that employs Flexion’s proprietary microsphere technology […]

Game Ready® Receives FDA 510(k) Clearance For Med4 Elite™ Multi-Modality Recovery Device
Regulatory

Game Ready® Receives FDA 510(k) Clearance For Med4 Elite™ Multi-Modality Recovery Device

CONCORD, Calif., Oct. 6, 2017 /PRNewswire/ — The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary orthopedic rehabilitation device, the Med4 Elite™. Since the company was founded in 1997, Game Ready’s cold and […]

Tangible Solutions Inc., Achieves ISO 13485:2016 and 9001:2015 Certification
Regulatory

Tangible Solutions Inc., Achieves ISO 13485:2016 and 9001:2015 Certification

September 29, 2017 Fairborn, Oh – September, 2017, Tangible Solutions, Inc., Contract Manufacturer of 3D Printed Implants operates a quality management system and has received full certification in compliance with ISO 13485:2016 and 9001:2015. Tangible Solutions was independently audited and verified by Eagle Certification Group to conform to the specific requirements necessary to achieve […]

ChoiceSpine™ Granted FDA Clearance for 3D Printed Vertebral Body Replacement Device
Regulatory Spine Top Stories

ChoiceSpine™ Granted FDA Clearance for 3D Printed Vertebral Body Replacement Device

KNOXVILLE, TN (PRWEB) OCTOBER 04, 2017 ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market HAWKEYE Ti, a 3D Printed Titanium Vertebral Body Replacement (VBR) device. “Additive manufacturing techniques create intricate three-dimensional […]

Intellijoint Surgical Inc. Receives CE Mark Approval for Flagship Product intellijoint HIP®
Recon Regulatory

Intellijoint Surgical Inc. Receives CE Mark Approval for Flagship Product intellijoint HIP®

WATERLOO, ON, Oct. 4, 2017 /PRNewswire/ – Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received the approval of the CE Mark (Conformité Européenne) for its intellijoint HIP® System in Europe. A 3D Mini-Optical Navigation System, intellijoint HIP® provides surgeons with precise measurements for cup position, leg length and offset for Total […]

Nexxt Spine Announces FDA Clearance for the NEXXT MATRIXX™ System
Regulatory Spine Top Stories

Nexxt Spine Announces FDA Clearance for the NEXXT MATRIXX™ System

October 04, 2017 NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine, LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the NEXXT MATRIXX™ System. The NEXXT MATRIXX™ System of 3D printed […]