Pretty much a year after having gained the FDA’s nod for its Fortiva Porcine Dermis Patch, RTI Surgical Inc. has received CE mark approval for the product and says it will begin distribution throughout Europe.
Products
CE Mark for First 3D Stereoradiographic Planning Software
A pioneer in orthopaedic 2D/3D imaging, EOS imaging has announced the CE mark of hipEOS, a 3D hip arthroplasty planning software based on EOS biplanar 3D imaging.
FDA Clears VentriPoint VMS™ Heart Imaging System, Enabling Early Warning of Pulmonary Arterial Hypertension
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
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.
Exactech Broadens Equinoxe® Shoulder System with New Resurfacing Humeral Head
Exactech, Inc. has taken the opportunity presented by this week’s AAOS meeting to announce successful first surgeries using its new Equinoxe® Resurfacing Humeral Head.
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.
New Valve Reduces Anticoagulant Requirement. EU Launch for On-X® Plus 1.5™ Next Week
On-X® Life Technologies Inc. has announced that it will officially launch its On-X Plus 1.5 Aortic Heart Valve at the Annual Meeting & Cardiothoracic Forum of the Society for Cardiothoracic Surgery in Great Britain & Ireland, March 10-12, Edinburgh, Scotland.
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.
Deaths Prompt Thoratec to Issue Warning on HeartMate II® LVAS
Heart assist device company Thoratec Corporation has initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II® LVAS Pocket System Controller. The advisory follows four deaths among patients while initiating switches of controller.
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.
Eucomed Boss Updates Position on EU MDD Revisions
Eucomed’s Chief Executive, Serge Bernasconi is making sure medtech industry’s voice is being heard right until the last minute as final wording is being inked into the new medical device directives. Highlights from his newly issued blog included here.
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.