Tag: FDA
US FDA seeks to “modernise” clinical trials with new draft guidance
The US Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernising the design...
SpineGuard obtains FDA clearance for commercial release of its Threaded PediGuard...
SpineGuard has received 510(k) clearance by the US Food and Drug Administration for the commercial release in the USA of its Threaded PediGuard device...
FDA issues two final guidances for including patient perspectives in medical...
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.
As...
CoreLink announces FDA clearance for F3D Corpectomy Vertebral Body Replacement System
CoreLink has announced the commercial launch and 510(k) clearance from the US Food and Drug Administration (FDA) for its F3D Corpectomy Vertebral Body Replacement (VBR)...
Spino Modulation granted FDA breakthrough device designation for MIScoli vertebral body...
Spino Modulation, a subsidiary of Spinologics, has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its MIScoli system,...
ONWARD receives breakthrough device designation for ARC-IM platform
ONWARD has announced the that it has received breakthrough device designation status from the US Food and Drug Administration (FDA) for their ARC-IM platform...
Neo Medical lands FDA approval and CE certification for Pedicle Screw...
Neo Medical has received US Food and Drug Administration (FDA) 510(k) clearance for the use of its Pedicle Screw System in late stage tumour...
Empirical Spine closes US$10 Million Series B financing round
Empirical Spine has announced the closing of a US$10 million Series B financing round, the funds of which will be used to advance its...
Medtronic receives FDA clearance for patient-specific UNiD Rods
Medtronic has announced that it has received US Food and Drug Administration (FDA) clearance of patient-specific UNiD Rods for use with its CD Horizon...
Spinal Stabilization Technologies receives CE Mark and FDA breakthrough designation for...
Spinal Stabilization Technologies (SST) has announced that it has earned the CE Mark and the FDA's breakthrough designation for its PerQdisc™ Nucleus Replacement System...
ChoiceSpine announces FDA clearance and clinical use of Blackhawk Ti cervical...
ChoiceSpine has announced that it has received clearance from the US Food and Drug Administration (FDA) to market the Blackhawk Ti cervical spacer system.
According...
CUREXO expands global reach after its spinal surgery robot acquires FDA...
South Korean medical robotics company CUREXO has announced that its spinal surgery robot, CUVIS-spine, has now acquired US Food and Drug Administration (FDA) licensing.
This...
Cerapedics granted breakthrough device designation for P-15L bone graft
Cerapedics has announced that it has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its investigational P-15L bone...
First clinical cases with V-Strut spinal vertebral implant
Hyprevention has announced the first clinical cases performed in the USA with its V-Strut vertebral implant product to treat vertebral fractures. The US Food and Drug Administration (FDA) cleared V-Strut vertebral implant is indicated for use in...
Mainstay Medical announces FDA approval of ReActiv8 neurostimulation system for chronic...
Mainstay Medical has announced that the US Food and Drug Administration (FDA) has approved the company’s premarket approval (PMA) application for ReActiv8, its implantable...
CDRH adjusts working practices with medical device companies to deal with...
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has written to the medical device industry to outline its...
CarboFix announces FDA clearance of Vertebral Body Replacement (VBR) System
CarboFix has announced that the US Food and Drug Administration (FDA) has cleared its CarboClear Carbon Fiber Vertebral Body Replacement (VBR) System to replace...
Scott Gottlieb resigns as head of US FDA
The commissioner of the US Food and Drug Administration (FDA), Scott Gottlieb, has unexpectedly resigned after serving just shy of two years in the...
US government shutdown disrupting FDA work
The US government shutdown means the country’s Food and Drug Administration (FDA) cannot accept new user fees, which means the agency cannot accept new...
Banned in the USA: Petition calls for FDA to prohibit reprocessed...
Aakash Agarwal (Department of Bioengineering and Orthopaedic Surgery, Engineering Center for Orthopaedic Research Excellence, University of Toledo, Toledo, USA) has filed an official citizen...
FDA advisory committee to review Evenity (romosozumab) for the treatment of...
The US Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) are to review data supporting the Biologics License Application...
US FDA plan shakeup of its 510(k) clearance programme
The US FDA has announced plans to modernise its 510(k) clearance programme for approving medical devices for the US market. Data show that about...
Zimmer Biomet recalls 1,360 spinal fusion and long bone stimulators
Zimmer Biomet recalled 1,360 spinal fusion and long bone stimulators due to a lack of adequate validation and controls to ensure product cleanliness. The...
Vertiflex announces 85% reduction in patients using opioids after treatment with...
Vertiflex has announced additional results from a randomised, controlled trial of its Superion Indirect Decompression System in patients with lumbar spinal stenosis (LSS). The...
NuVasive’s Porous PEEK impant to be used in flagship XLIF procedure
NuVasive has announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for use of its COHERE Porous PEEK implant...
FDA approval granted for Eden Spine’s Sphynx
Eden Spine’s Sphynx plating system has been granted FDA clearance, the company has announced.
Sphynx was designed to complement the company’s Giza titanium vertebral body...
FDA clears first nanotechnology PEEK devices for spinal intervertebral fusion
The US Food and Drug Administration (FDA) has granted approval to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus nanotextured surface...
FDA clearance granted for Hive-C cervical interbody devices
HD LifeSciences has received FDA 510(k) clearance for its Hive-C IBFD, a system of interbody devices for anterior cervical fusion procedures.
The Hive-C implant system...
Renovis Surgical receives FDA clearance for Tesera Trabecular Technology Hyperlordotic ALIF...
Renovis Surgical Technologies has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Tesera SA...
First patented single implant sacroiliac joint fusion system receives FDA clearance
The US Food and Drug Administration (FDA) have granted clearance for the Catamaran sacroiliac joint fixation system (Tenon Medical) specifically indicated for sacroiliac joint...
Bone cement solution indicated for treating sacral fractures granted FDA approval
The US Food and Drug Administration (FDA) has granted 510(k) clearance of Kyphon HV-R bone cement (Medtronic) for fixation of pathological fractures of the...
Spine surgery products market will value $16.7 billion by 2025
The global spine surgery products market is expected to reach US$16.7 billion by 2025, up from US$10.2 billion in 2016, a Transparency Market Research...
Paradigm Spine receives FDA pre-market approval (PMA) for first of its...
The US Food and Drug Administration (FDA) has granted pre-market supplemental approval (PMA) for the coflex interlaminar stabilisation disposable instrument kit (Paradigm Spine). This...
Europe braces for harder times in medical device innovation while US...
Countries in the European Union have long been the first to receive new innovations in medical technology, as the EU’s Medical Device Directive (MDD)...
Rampart One standard ALIF interbody fusion system gains FDA clearance for...
The Rampart One Standard anterior lumbar interbody fusion (ALIF) device (Spineology) has been granted FDA clearance, allowing it to be used with or without...
FDA 510(k) clearance for cervical and lumbar HA PEEK interbody...
The US Food and Drug Administration (FDA) has granted 510(k) clearance for both the ALTA ACDF interbody spacers (Astura Medical) and HALF DOME lumbar...
Camber Spine announces 510(k) approval of ENZA-A titanium ALIF
The US Food and Drug Administration (FDA) has given 510(k) clearance to Camber Spine to market its ENZA-A titanium anterior lumbar interbody fusion (ALIF)...
Zimmer Biomet announces 510(k) clearance for Zyston strut open titanium interbody...
The US Food and Drug Administration (FDA) has given 510(k) clearance for the Zyston strut open titanium interbody spacer system (Zimmer Biomet). This marks...
FDA approval for Infuse Bone Graft in expanded spinal surgery indications
Infuse Bone Graft (Medtronic) has gained US Food and Drug Administration (FDA) approval in new spine surgery indications. InfuseBone Graft is now approved for...
CTL Medical secures FDA approval for its MATISSE Titanium-PEEK ACIF cage...
CTL Medical, a Dallas-based medical device manufacturing and service company, has secured US Food and Drug Administration (FDA) clearance and approval to market its...
Cerapedics receives FDA approval to initiate IDE study of P-15L bone...
Cerapedics, a privately-held orthobiologics company, has announced the company received approval from the US Food and Drug Administration (FDA) to initiate an investigational device...
First cases using the Triojection System to treat disc herniation completed...
The first cases using the Triojection system to treat spinal disc herniations in Germany were recently performed, Minimus Spine Inc. has announced. The cases...
Spira-C cervical interbody cleared by US FDA
Camber Spine has announced the clearance by the US Food and Drug Administration (FDA) of its Spira-C Open Matrix cervical interbody device, a fusion...
Trump declares opioid crisis a public health emergency
“The United States is by far the largest consumer of these drugs, using more opioid pills per person than any other country … in the...
DiscGenics’ IDCT Investigational New Drug application accepted by US FDA
DiscGenics has been notified by the US Food and Drug Administration (FDA) that an Investigational New Drug (IND) application for a clinical study of...
US FDA clears Nuvasive’s redesigned Magec system
NuVasive has received 510(k) clearance from the US Food and Drug Administration (FDA) for use of the company's redesigned Magec system with its Reline...
US FDA clears Stryker’s Tritanium C anterior cervical cage
Stryker’s Tritanium C anterior cervical cage, a 3D-printed interbody fusion cage intended for use in the cervical spine, has received 510(k) clearance from the...
US FDA approves Medtronic’s Intellis spinal cord stimulation device
The US Food and Drug Administration has approved Medtronic’s Intellis spinal cord stimulator. The company has now launched the product in the USA for...
US FDA clears Globus Medical’s Excelsius GPS robotic system
The Excelsius GPS robotic guidance and navigation system from Globus Medical has been 510(k) cleared by the US Food and Drug Administration (FDA).
The robotic...
US FDA clears Stryker’s Serrato pedicle screw
Stryker’s Spine division has announced that its Serrato pedicle screw, intended for use in the non-cervical spine as part of the company’s Xia 3...
Mainstay Medical’s ReActiv8 clinical trial passes enrolment mid-point
Over half the required number of implants in Mainstay Medical’s ReActiv8-B clinical trial have been performed. The clinical trial is investigating the company’s novel...
Implanet announces the commercial launch of the new Jazz Braid in...
Implanet has obtained marketing clearance from the US and European regulatory authorities to market its new Jazz Braid.
The new Jazz Braid is an updated...
US FDA approves IDE study for Premia Spine’s Tops system
Premia Spine has secured US Food and Drug Administration approval for its pivotal study of the new Tops system.
“We are excited about the opportunity to...
US FDA clears Spinal Simplicity’s Minuteman G3-R removable end fusion implant
Spinal Simplicity has received its third 510(k) clearance from the US Food and Drug Administration (FDA) for the Minuteman G3-R spinal implant, part of...
Implanet receives US and European marketing clearance for Jazz Frame
Implanet has been granted both US Food and Drug Administration (FDA) 510(k) clearance and CE marking to market its new Jazz Frame implant.
The Jazz...
First surgery with Amedica’s Taurus pedicle screw system successful
Amedica has announced the successful completion of the first surgery using its Taurus pedicle screw system.
The surgery was performed by Thomas Scioscia, in Richmond,...
Safe Orthopaedics announces launch of bone substitute
Safe Orthopaedics has announced the launch of a bone substitute for its Walnut cage for cervical surgeries in Europe.
This device, developed in conjunction with...
US FDA downgrades class III pedicle screws to class II
The US Food and Drug Administration (FDA) has formally reclassified pedicle screws from class III to class II devices. The reclassification came into force...
US FDA clears Precision Spine’s AccuFit lateral plating system
Precision Spine has received US Food and Drug Administration (FDA) 510(k) clearance of its AccuFit lateral plating system.
The AccuFit plate is designed to provide...
US FDA bans powdered gloves
The US Food and Drug Administration (FDA) has issued a final rule to ban powdered surgical gloves, patient examination gloves and the absorbable powder...
SpineGuard to launch PedGuard Threaded drilling device at NASS 2016
SpineGuard is to launch its next-generation PediGuard “Threaded” device using the company’s Dynamic Surgical Guidance technology the 31st annual meeting of the North American...
US FDA approves Spineology Rampart devices with allograft bone
Spineology has obtained US Food and Drug Administration (FDA)-clearance for the use of allograft bone with its Rampart Interbody Fusion Devices.
“This approval and our...
Ohio judge dismisses hundreds of off-label Medtronic Infuse patient lawsuits
US district court judge, Timothy S Black (Southern Ohio, USA) has dismissed the accusation of several hundred plaintiffs that they have been treated off-label...
Spinal Elements receives 510(k) clearance for interspinous process device
Spinal Elements has received 510(k) clearance from the USA Food and Drug Administration (FDA) to market an interspinous process device.
Spinal Elements’ device includes enhancements...