Aptus Endosystems has gained CE mark approval for the thoracic version of its Heli-FX™ endovascular aneurysm repair graft. The the new system consists of a longer delivery device with additional tip configurations to bring the innovative helical EndoAnchor™ technology to the treatment of thoracic aortic aneurysms.
Regulatory
FDA Clears New Navigator® Delivery System For Safe And Accurate Musculoskeletal Injections
Drug delivery device company Carticept Medical, Inc., has received FDA 510(k) clearance to market its enhanced Navigator® Delivery System (DS). Navigator DS is the first and only FDA-cleared, computer-controlled injection system intended to increase the efficiency, comfort, safety and accuracy of musculoskeletal injections.
FDA Clears Teleflex ISO-Gard® Mask, Reducing Caregiver Exposure To Exhaled Hazardous Gases
Critical care device company Teleflex Inc, has announced that its Anesthesia and Respiratory business unit has received FDA 510(k) clearance for its ISO-Gard® Mask with ClearAir™ Technology. The company says this novel product helps to reduce clinician exposure to hazardous waste anesthetic gases exhaled in “recovery”.
Boston Scientific Launches Precision Spectra™ Spinal Cord Stimulator System In The United States
Boston Scientific Corporation has received U.S. FDA approval for its Precision Spectra Spinal Cord Stimulator System. The company is now beginning a limited launch of what it says is the world’s first and only SCS system with Illumina 3D™ software and 32 contacts.
FDA Clears Biolase Soft Tissue Diode Laser For Broad Surgical Indications
It would be easier to list the indications for which Biolase’s soft tissue laser has not been cleared, given that the 80 inclusions cover all aspects of surgical excision. Undeniably smart to take a dental laser and make it work in surgery, the company is now seeking commercialisation partners across other disciplines.
Stryker’s Shapematch® Cutting Guide Issue Becomes An FDA Class I Recall
Stryker’s Shapematch cutting guide was the subject of a company recall last November. Now the FDA has upgraded the recall to Class I status, indicating the high risk it has placed on use of the device.
Medtech Industry Bids To Get Rid Of Transatlantic Regulatory Anachronism
The regulators either side of the pond may have their own ideas, but industry bodies unencumbered by political protectionism are free to shout up for some convergence. And why not… the existence of such divergent systems at the present time looks hopelessly nonsensical in today’s small world.
FDA Clearance of Terumo’s Blood Collection And Storage System Means Plasma Goes Further
With a new FDA clearance, blood centers in the United States can now collect platelets on the Trima Accel system in 65 percent less plasma volume and store platelets in Isoplate for up to five days.
St. Jude Receives First CE Mark Approval Of Deep Brain Stimulation Systems For Both Primary And Secondary Dystonia
The CE mark approval of St.Jude’s deep brain stimulation devices represents the first by a regulatory agency for the use of deep brain stimulation to manage both primary and secondary dystonia.
CE Mark Extension For Laser And FDA Panel Nod For IOL: Good Week For Bausch + Lomb
Bausch + Lomb, has extended the CE mark status for its VICTUS® femtosecond laser platform to include the creation of corneal incisions in patients undergoing cataract surgery. Two other new indications were included, including penetrating keratoplasty and the creation of intrastromal channel incisions for intracorneal ring segments.
FDA Recall For Animas Corp’s 2020 Insulin Infusion Pump
The FDA has issued a Class I recall notice relating to the Animas® 2020 Insulin Pump. It seems there are two problems with the device. A Class I recall notice, is the FDA’s most serious type of recall and reserved for cases where human health is at risk by continued use of the device.
FDA Clears NeuroBlate MRI-Guided Brain Tumour Ablation System
Monteris® Medical has announced that the U.S. FDA has issued a second 510(k) clearance for its MRI-guided ablation device for brain tumors and other lesions.
InVivo’s Spinal Cord Injury Technology Study Could Mean Faster U.S. Approval
The FDA has approved an IDE for InVivo’s biopolymer scaffold, making it the first such treatment to dip its toe in the America patient population. The new study is expected to deliver a Humanitarian Device Exemption, giving it access to market sooner than a PMA.
Medtronic’s Newly CE Marked AAA Stent Graft Introducer Sheath Showcased At CX Symposium This Weekend
This weekend (April 6-9) sees the 35th running of the Charing Cross Vascular Symposium in London. Medtronic has just received CE mark approval for its new AAA stent graft introducer sheath and will be showcasing it among its other offerings at the event.
Why It’s All Gone Quiet On EU Medical Device Regs Changes
In short For those of us with an inbuilt action-orientation, it seems like the wheels of European legislature turn extremely … continue reading “Why It’s All Gone Quiet On EU Medical Device Regs Changes”
FDA Clears Hitachi’s SCENARIA™ Advanced 128-Slice CT System
Hitachi Medical Systems America, Inc., has announced FDA clearance to market its SCENARIA Advanced 128 CT system, the newest model of the SCENARIA scalable CT platform. The company claims enhanced patient access and rapid workflow for its 128-slice model that it says provides both routine and advanced applications with enhanced performance and value.