Spinal cord injuries(SCI) technologist, InVivo Therapeutics Corporation has been forced to issue an update on the clinical timeline for its biopolymer scaffolding to treat acute SCI. It seems the FDA wants the patients in its IDE trial to be staggered rather than simultaneous as the company had planned.
Regulatory
FDA Clears Zimmer’s Patient Specific Instruments (PSI) Shoulder System
Zimmer’s PSI Shoulder utilizes 3D visualization software to allow a surgeon to create a customized surgical plan for each patient, and then provides patient-specific surgical instrument guides to facilitate placement of the implant corresponding to the plan.
Welcome to the Theradome™ as FDA Clears “Clinical Strength” Home Laser Hair Therapy Device
Theradome™ Inc has seen its LH80 laser helmet gain FDA’s clearance, bringing a so-called “clinical strength” therapy to the home for a fraction of the cost of visiting a hair restoration clinic.
FDA clears NovoPen Echo® Insulin Injection Device
The FDA has cleared Novo Nordisk’s novel NovoPen Echo, the first insulin injection device to combine half-unit dosing with a memory function to help patients better manage their diabetes
ExAblate Receives Approval of Health Canada for the Treatment of Uterine Fibroids and Pain Palliation of Bone Metastases
InSightec Ltd, a leader in MR guided Focused Ultrasound therapy, announced that its ExAblate system has received approval of Health Canada for MRgFUS treatment of uterine fibroids and for pain palliation of bone metastases.
CE Mark for The Stork®, “Bringer of Pregnancy”
Intuitively one can imagine a device that delivers semen directly to the cervical opening, might just work. Now that “The Stork” has gained CE mark approval it seems the European authorities buy the story too.
FDA Clears Reverse Medical’s MVP™ Micro Vascular Plug for Peripheral Embolization
Reverse Medical Corporation has gained FDA clearance for US commercialization of its MVP™ Micro Vascular Plug system for peripheral artery embolization, and the first US clinical cases.
FDA Nod for Boston Scientific’s IntellaTip MiFi™ XP Ablation Catheter and Zurpaz™ 8.5F Steerable Sheath
Boston Scientific Corporation continues to expand its electrophysiology (EP) offerings with U.S. FDA approval of its IntellaTip MiFi™ XP catheter and 510(k) clearance of its Zurpaz™ 8.5F steerable sheath. The company says these products join its growing portfolio of next generation EP tools designed to redefine ablation technology.
FDA Clears AngioDynamics’ Thrombus-Reducing Ports
AngioDynamics, Inc. has announced the U.S. FDA 510(k) clearance through its subsidiary business Navilyst Medical Inc., for its BioFlo Port with Endexo technology, which is designed to reduce the accumulation of catheter-related thrombus on, and in, the port catheter.
FDA Clears CoAlign’s AccuLIF® Expandable Interbody Device Product Line for Lateral Surgical Approaches
CoAlign Innovations, Inc. has announced that its AccuLIF® XL lateral expandable interbody fusion devices have received marketing clearance from the U.S. FDA. This new product line addresses spinal fusion procedures employing the lateral approach.
St.Jude’s Newly Approved Ablation Navigation System Reduces Radiation Exposure
St. Jude Medical, Inc., has seen its MediGuide Enabled™ Ablation Catheters gain U.S. FDA approval. The company is touting reduction in radiation exposure for patients, MediGuide using a previously recorded fluoroscopic map of the target tissue.
FDA Clears Given Imaging’s Next Generation PillCam® SB 3
Improved PillCam SB Technology promises a more detailed and efficient small bowel examination for patients with conditions such as Crohn’s Disease and obscure GI Bleeding. And now it’s FDA approved.
MHRA Device Alert: CareFusion Infusion Pumps
The UK’s regulatory overlord, the MHRA has issued a device alert pertaining to CareFusion’s Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails Infusion pumps, product codes 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G
Alere receives FDA Approval for Alere Determine™ HIV-1/2 Ag/Ab Combo
Diagnostics company Alere Inc., has announced today that it has received U.S. FDA approval of its pre-market application to market Alere Determine™ HIV 1/2 Ag/Ab Combo in the United States for the detection of HIV-1 p24 antigen and antibodies to HIV-1/HIV-2.
FDA Approves LDR’s Mobi-C Cervical Disc for One-Level Use
Spinal technology company LDR, offers exclusive spinal implant technologies for both non-fusion and fusion applications. Now the company has announced … continue reading “FDA Approves LDR’s Mobi-C Cervical Disc for One-Level Use”
FDA Says Wright’s Augment® Bone Graft Not Approvable Based on Study
Wright Medical Group, Inc. has announced it received a “not approvable” letter from the FDA in response to its Pre-Market Approval application for Augment® Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures.