Ventripoint Diagnostics Ltd. has announced that the U.S. FDA has cleared the VMS™ heart analysis system to be an adjunct to all existing 2D ultrasound imaging devices to allow computation of the 3D volume and ejection fraction of the right heart in patients with Pulmonary Arterial Hypertension
Approval/Clearance
FDA Clears Cardiovascular Systems’ Low Profile, 60cm Diamondback Orbital Atherectomy Devices
CSI’s new Diamondback Peripheral 60cm systems are available in two crown designs, the 1.25mm Micro Crown, and the 1.25mm Solid Crown. Each device offers a shorter shaft length, a smaller profile and a more flexible shaft than their predecessors for improved ease of use.
Maxx Ortho Claims Newly Cleared Freedom Knee® Revision System is the Most Bone-Conserving, Low Profile on the Market
The U.S. FDA has cleared Maxx Orthopaedics’ Freedom PCK Revision Knee System claimed by its manufacturer to be one of the most bone-conserving, low profile revision knee systems available on the market.
Toe Fusion can be Avoided now FDA has Cleared ToeMotion™ Toe Restoration System
It’s AAOS week in New Orleans and less invasive joint restoration company Arthrosurface, Inc.has chosen the event to announce receipt of FDA Clearance for its new ToeMotion™ Total Toe Restoration System.
AngioDynamics sees FDA Clear BioFlo DuraMax Hemodialysis Catheter and Takes Control of Celerity System
Quite a time for AngioDynamics. First the company gets news that another iteration of its successful BioFlo platform has gained FDA’s nod. Then, its distribution partner Medcomp gets the FDA’s knock-back over its 510(k) submission for the Celerity tip location system, leading AngioDynamics to take over the regulatory reigns there too.
First FDA Clearance for a Porous PEEK Implant
Whether this is a milestone or not remains to be seen, but it just might be. The PEEK polymer has become a household name in orthopaedic implants and now MedShape is offering devices with the combined advantages of PEEK and a porous structure to encourage tissue ingrowth.
First 4F MR Conditional CRT Lead CE Marked and In Use
Frequent visitor to our pages, cardiovascular device company Biotronik has announced the first implantations of the Sentus ProMRI® lead.
FDA Clearance Means InControl Medical has Both Ends Covered for Non-surgical Male and Female Fecal and Urinary Incontinence Device
InTone® MV is a clever device which combines muscle stimulation with voice-guided pelvic floor exercise, visual biofeedback, and a unique, customizable probe to create a home-based treatment for fecal and urinary incontinence in men and women.
EDGE™ Orthopaedics Receives First FDA 510(k) Clearance
New entrant into the orthopaedic device space, EDGE Orthopaedics has its first FDA 510(k) Clearance in the form of a range of compression screws.
Clearance for Implant that Retains Articulation During Knee Replacement Infection Treatment
Clever idea this. The FDA has just cleared a system known as KASM from Ortho Developments Corporation. These spacer molds are intended for use after removal of primary TKA implants following infection and offer a degree of articulation to the patient.
FDA Clears Covidien’s Puritan Bennett™ 980 Ventilator
Covidien plc has announced its Puritan Bennett™ 980 ventilator has received U.S. FDA 510(k) clearance. The company says its new acute care ventilator is designed to be simple, safe and smart and to enable patients to breathe more naturally than with conventional mechanical ventilators.
U.S. FDA 510(k) Clearance for Cardica’s MicroCutter XCHANGE™ 30 White Cartridge
Cardica, Inc. is a relative minnow in the world of minimally invasive surgical stapling devices. Now however it has announced two significant new FDA clearances that may well help it to compete with its rather bigger adversaries.
FDA Clearance and Launch of New Osteotomy Wedges from Integra
Integra LifeSciences Holdings Corporation has announced the FDA 510(k) clearance and commercial introduction of the Integra® Titanium Bone Wedges, designed for internal fixation for bone fractures or osteotomies in the foot and ankle.
FDA Clears Device to Avoid Nerve Injury Caused By “Positioning Effect”
Surgical patients can suffer nerve impairment due to so-called “positioning effect”. Now SafeOp Surgical’s newly FDA cleared system uses neurological monitoring to flag up potential peripheral nerve damage.
FDA Clearance for Paragonix Sherpa™ Cardiac Transport System
Paragonix Inc has big ideas about extending transit and storage time for donor hearts. For now though it’s satisfied with a new FDA clearance that sees its Sherpa Pak system good to enter the market for use within current guidelines.
First FDA Approval for Contact Force-Sensing Atrial Fibrillation Ablation Catheter
Contact force-sensing has become something of a buzz word in cardiac ablation as the benefits of being able to avoid too much or too little contact become apparent. Now Biosense Webster has become the first to get its contact force sensing catheter FDA approved.