Regulatory

Ziptek LLC Receives FDA Approval For ZipE®, the Innovative Knotless Tissue Repair Device
Regulatory Top Stories

Ziptek LLC Receives FDA Approval For ZipE®, the Innovative Knotless Tissue Repair Device

By PR Rocket on April 20, 2017 Ziptek LLC, founded by Sarasota-based orthopedic surgeon Dr. William Bennett M.D., is proud to announce its newly obtained FDA-approval for the ZipE® knotless tissue repair and attachment device. ZipE® is an absorbable button that moves down a suture, locking itself from moving backward […]

FDA Clears Halyard Health’s COOLIEF* for the Management of Osteoarthritis Knee Pain
Regulatory

FDA Clears Halyard Health’s COOLIEF* for the Management of Osteoarthritis Knee Pain

LAS VEGAS, April 20, 2017 /PRNewswire/ — American Society of Interventional Pain Physicians Annual Meeting, Booth #407 — Halyard Health (NYSE:  HYH), a medical technology company focused on eliminating pain, speeding recovery and preventing infection, today announced the U.S. Food and Drug Administration (FDA) has cleared for marketing its COOLIEF* […]

Life Spine Announces FDA Clearance of PLATEAU®-C Ti Cervical Spacer System
Regulatory

Life Spine Announces FDA Clearance of PLATEAU®-C Ti Cervical Spacer System

April 19, 2017 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) market clearance to the PLATEAU-C Ti Cervical Spacer System. PLATEAU-C Ti joins […]

Additive Orthopaedics Announces FDA Clearance of their Locking Lattice Plating System for the Global Extremities Market
Regulatory

Additive Orthopaedics Announces FDA Clearance of their Locking Lattice Plating System for the Global Extremities Market

LITTLE SILVER, N.J., April 13, 2017 /PRNewswire/ — Additive Orthopaedics, LLC., an early stage orthopaedic device company, today announced that is has received FDA 510(k) clearance for its 3D printed Locking Lattice Plating System, to address stabilization and fusion of fractures, osteotomies, and arthrodesis of small bones. According to Greg […]

United Orthopedic Corporation Receives U.S. FDA Clearance For Company’s Polyethylene Knee Insert
Regulatory

United Orthopedic Corporation Receives U.S. FDA Clearance For Company’s Polyethylene Knee Insert

IRVINE, Calif., April 12, 2017 /PRNewswire/ — United Orthopedic Corporation (UOC), a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments, today announced that the U.S. Food and Drug Administration (FDA) cleared its E-XPE™ polyethylene knee insert. The knee insert is designed to provide patients with knee replacements […]

Mazor Robotics Receives FDA Clearance for Spinal Deformity Correction Planning Software for the Mazor X Surgical Assurance Platform
Regulatory Robotics

Mazor Robotics Receives FDA Clearance for Spinal Deformity Correction Planning Software for the Mazor X Surgical Assurance Platform

April 12, 2017 CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR)(NASDAQGM: MZOR), a pioneer and leader in the field of surgical guidance systems, has received FDA clearance for its Mazor X Align™ software. Mazor X Align is designed to assist surgeons in planning spinal deformity correction and spinal alignment for procedures […]

KFx Medical, LLC Announces Another and Third License of its Knotless Double Row Patents
Regulatory Sports Medicine

KFx Medical, LLC Announces Another and Third License of its Knotless Double Row Patents

April 06, 2017 SAN DIEGO–(BUSINESS WIRE)–KFx Medical, LLC announced that it has entered into a license agreement with CONMED Corporation – CNMD (NASDAQ) relating to its patents used in knotless double row rotator cuff repair. Under the agreement, CONMED and its affiliates will have the right to promote the use of […]

Milestone Scientific Announces Regulatory Marketing Clearance to Sell Epidural and Intra-Articular Instruments and Disposables in Australia
Regulatory

Milestone Scientific Announces Regulatory Marketing Clearance to Sell Epidural and Intra-Articular Instruments and Disposables in Australia

LIVINGSTON, NJ –(Marketwired – April 04, 2017) – Milestone Scientific Inc. (NYSE MKT: MLSS), a medical R&D company that designs, patents, incubates and commercializes a growing portfolio of innovative injection technologies, today announced that it has been granted marketing clearance for its epidural and intra-articular instruments and disposables in Australia. […]

Flexion Therapeutics Announces Issuance of Two New Patents
Regulatory

Flexion Therapeutics Announces Issuance of Two New Patents

BURLINGTON, Mass., April 04, 2017 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the U.S. Patent and Trademark Office has issued two new patents covering the company’s lead investigational product candidate ZilrettaTM (FX006). The new patents further strengthen the existing patent estate surrounding Zilretta. The patents cover the injectable […]

Bodycad Receives FDA 510K Clearance for Personalized Unicompartmental Knee System
Regulatory

Bodycad Receives FDA 510K Clearance for Personalized Unicompartmental Knee System

QUEBEC CITY, March 29, 2017 /PRNewswire/ — Bodycad announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bodycad Unicompartmental Knee System, enabling the commercial launch of this truly personalized orthopaedic restoration. Bodycad is the first Canadian company to receive FDA clearance for a joint […]

Providence Medical Technology Receives New FDA 510(k) Clearances and Bolsters Executive Management Team
Regulatory Spine Top Stories

Providence Medical Technology Receives New FDA 510(k) Clearances and Bolsters Executive Management Team

WALNUT CREEK, Calif., Mar 29, 2017 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing, cervical-fusion technology, announced the addition of two industry veterans to the commercial leadership team.  Scott Lynch has joined the company to lead Global Marketing, and Michael Scott is assuming International leadership.  Together, Mr. Lynch and […]

NuVasive Receives First-Ever FDA Clearance For Cervical Interbody Implant System Used In More Than Two Levels
Regulatory Spine

NuVasive Receives First-Ever FDA Clearance For Cervical Interbody Implant System Used In More Than Two Levels

SAN DIEGO, March 29, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the CoRoent® Small Interbody™ System indicated for intervertebral body fusion at multiple contiguous levels […]

SafeOp Surgical Files for Ninth Patent
Neuro Regulatory Top Stories

SafeOp Surgical Files for Ninth Patent

March 27, 2017 HUNT VALLEY, Md.–(BUSINESS WIRE)–SafeOp Surgical, Inc. (“SafeOp”), a privately held medical device company, today announced that it has filed its ninth patent application for innovations surrounding the monitoring of somatosensory-evoked potentials during surgeries. SafeOp developed and markets the EPAD™ system, a revolutionary neuromonitoring system that enables the […]