Tag: US FDA
Paclitaxel controversy: Yes, device restrictions did cause harm
“Unfortunately, we are doing worse for our patients today,” were the sobering thoughts of Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA) during...
Shape Memory Medical advances endovascular embolisation by completing $38 million in...
Shape Memory Medical has announced that it has completed $38 million in Series C financing, which has been led by Earlybird Venture Capital, along...
TCT 2023: First presentation of complete patient-level dataset on paclitaxel and...
Data from a patient-level meta-analysis—a factor in the US Food and Drug Administration’s (FDA) recent change of position on the use of paclitaxel-coated devices...
FDA update: Paclitaxel-coated devices for PAD cleared of excess mortality risk,...
This advertorial is sponsored by Boston Scientific.
Data on hundreds of thousands of patients who have received lower limb endovascular treatment provide confidence in paclitaxel...
CIRSE supports use of paclitaxel-coated devices in femoropopliteal disease treatment
In June 2023, the Cardiovascular Interventional Radiological Society of Europe (CIRSE) published an editorial in Cardiovascular Interventional Radiology (CVIR). Written on behalf of CIRSE’s...
Timeline: Key milestones in the paclitaxel story
The release of a letter from the US Food and Drug Administration (FDA) concerning the use of paclitaxel coated devices for the peripheral arterial...
Long-awaited US FDA update finds data do not support excess mortality...
In a letter to healthcare providers dated 11 July 2023, the US Food and Drug Administration (FDA) communicates that the risk of mortality associated...
Interventional News’ top 10 most popular stories of January 2023
Interventional News’ most popular stories in the opening month of 2023 included news of first enrolments in clinical studies of peripheral arterial disease (PAD)...
Interventional News’ top 10 most popular stories of December 2022
Interventional News’ most popular stories as 2022 came to a close included news of a US Food and Drug Administration clearance for a new...
Swiss parliament votes to accept US FDA-approved medical devices
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion...
Biotronik’s Pulsar-18 T3 peripheral self-expanding stent system receives FDA approval
Biotronik recently announced that it has received US Food and Drug Administration (FDA) approval of its Pulsar-18 T3 peripheral self-expanding stent system. Full US...
New long-term data of paclitaxel devices continue to show no increased...
New long-term data from the SAFE-PAD (Safety assessment of femoropopliteal endovascular treatment with paclitaxel-coated devices) study were presented today as late-breaking clinical research at...
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...
NIH grant sets Mercator research underway for local anti-inflammatory DVT therapy
Mercator MedSystems has recently announced that the DEXTERITY trials research has begun under a technology transfer grant for approximately $300,000 funded by the National...
Rapid Medical to initiate trial expanding thrombectomy treatment across distal regions...
Rapid Medical today announced US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for what it claims is the first-ever trial to...
FDA clears 12 new XO Cross microcatheters
Transit Scientific has announced US Food and Drug Administration (FDA) clearance of new hydrophilic-coated XO Cross microcatheters for guidewire support, exchange, and contrast media...
Sanford invents Breakthrough Device for vascular disease
An investigational device invented at Sanford Health (Sioux Falls, USA) that helps high-risk vascular disease patients has been granted a Breakthrough Device designation by...
BD announces 510(k) clearance of expanded indications for the Rotarex atherectomy...
BD recently announced it has received 510(k) clearance for expanded indications from the US Food and Drug Administration (FDA) for the Rotarex atherectomy system.
The...
FDA clears Koya Medical’s Dayspring compression system for lower extremities
Koya Medical announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its active compression therapy system Dayspring for...
Interventionalists encouraged to consult talking points document on paclitaxel devices
Interventionalists are being encouraged to take consideration of a set of talking points about the risks and benefits of paclitaxel-equipped devices—which has developed by...
Surmodics receives FDA 510(k) clearance for Sublime radial access 0.014 RX...
Surmodics recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its Sublime radial access 0.014 rapid exchange (RX) percutaneous...
Merit Medical’s Wrapsody System receives CE mark
Merit Medical has received CE mark approval for the Wrapsody endovascular stent graft system from the British Standards Institution. The Wrapsody system is a...
FDA clears Aspire MAX mechanical thrombectomy system
Control Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared its Aspire MAX 7 – 11F mechanical thrombectomy...
Okami Medical announces first patients treated with Lobo vascular occluder
Okami Medical has announced the successful completion of the first cases with the Lobo vascular occlusion system. The first offering in the company's product...
LIVE blog: US FDA host public workshop on extended reality in...
The US Food and Drug Administration (FDA) is hosting a public workshop entitled "Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented...
FDA grants de novo clearance to Bluegrass Vascular for Surfacer system
Bluegrass Vascular Technologies (Bluegrass Vascular) announced today that the US Food and Drug Administration (FDA) has granted a de novo classification order for its...
Rist Neurovascular radial artery catheter receives FDA 510(k) clearance
Rist Neurovascular recently announced that it has received US Food and Drug Administration (FDA) 510(k) clearance to market the Rist Cath Radial Access Long...
MedAlliance receives third FDA breakthrough device designation for its sirolimus DEB...
MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) breakthrough device designation status for a...
Medtronic DCB receives US FDA approval to treat arteriovenous fistula lesions
Medtronic today announced US Food and Drug Administration (FDA) approval of the IN.PACT AV drug-coated balloon (DCB), a paclitaxel-coated balloon indicated for the treatment...
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...
Acessa Health wins FDA nod for 3rd generation ProVu
Acessa Health has announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance for its third generation Acessa ProVu radiofrequency ablation...
BD acquires TVA Medical, makers of everlinQ endoAVF System
BD (Becton, Dickinson and Company) announced it has completed the acquisition of TVA Medical, a company that develops minimally invasive vascular access solutions...
Medtronic receives US FDA clearance for 200mm and 250mm IN.PACT Admiral...
Medtronic has announced that it has received US FDA approval for 200mm and 250mm lengths of the IN.PACT Admiral drug-coated balloon (DCB) to treat...
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)...
Embozene microspheres are now indicated for prostate artery embolization
Boston Scientific showed at the Global Embolization Cancer Symposium and Technologies (GEST US; 17–19 May, Miami Beach, USA) meeting that the US Food and...
US FDA clears CorPath GRX system for use in peripheral vascular...
Corindus has announced receiving 510(k) clearance from the US Food and Drug Administration (FDA) for use of the CorPath GRX system in peripheral vascular...
LimFlow completes enrolment in US feasibility study
LimFlow has announced completion of enrolment of the original 10-patient cohort in the US feasibility study of the LimFlow percutaneous deep vein arterialisation system....
XableCath gets US FDA clearance for broadly effective catheter aimed at...
XableCath has announced its XableCath blunt tip support catheter has received clearance from the US FDA. The blunt tip catheter facilitates true lumen passage...
Study finds no evidence that gadolinium causes neurologic harm
There is no evidence that accumulation in the brain of the element gadolinium speeds cognitive decline, according to a new study presented at the...
US FDA clears first 7T magnetic resonance imaging device
The US Food and Drug Administration has cleared the first seven tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic...
Bard gets US FDA premarket approval for Lutonix 035 DCB in...
Bard’s Lutonix 035 drug-coated balloon PTA catheter (DCB) has been granted premarket approval (PMA) by the US Food and Drug Administration (FDA) for a...
Spectranetics announces FDA approval of Stellarex drug-coated balloon
Spectranetics has announced receipt of US Food and Drug Administration (FDA) premarket approval of the Stellarex drug-coated balloon (DCB), designed to restore and maintain...
Embosphere receives US FDA de novo classification for prostatic artery embolization
Merit Medical has announced that it has received 513(f)(2) (de novo) classification from the FDA to expand indication for its Embosphere microspheres. The indication...
First patient enrolled in IN.PACT arteriovenous access drug-coated balloon study
The US FDA has approved the investigational device exemption (IDE) study to evaluate the safety and efficacy of IN.PACT AV access drug-coated balloon as...
Mirabilis announces European approval for non-invasive uterine fibroid treatment
Mirabilis has announced CE mark authorisation to market the Mirabilis System in the European Union. The system combines high-speed therapeutic ultrasound technology with an...
BTG receives US FDA 510(k) clearance for Ekos control unit 4.0
BTG has announced that US FDA 510(k) clearance has been granted to the Ekos control unit 4.0.
The Ekos system includes an ultrasonic device...
Robert Califf to resign as US FDA commissioner
Robert Califf is to step down as US Food and Drug Administration (FDA) commissioner upon the inauguration of Donald Trump as US President on...
NICE collaborates with US FDA on Payer Communication Taskforce
NICE’s Scientific Advice programme will work with companies looking to attain both FDA approval and payer coverageThe UK’s National Institute for Health and Care...
Final patient enrolled for VIVO iliofemoral venous stent study
Cook Medical has completed enrolment in the first clinical study of an iliofemoral venous stent conducted in the USA under a US FDA-approved investigational device exemption.
The...
Merit Medical receives 510(k) clearance for the SwiftNinja steerable microcatheter
Merit Medical Systems has received 510(k) clearance for the SwiftNinja steerable microcatheter, covering peripheral and coronary applications.
With the exception of Japan, Merit has global...
Teleflex receives US FDA clearance for Arrow and TightTrack tunneler
Teleflex has announced that it has received US FDA 510(k) clearance to market its Arrow JACC with Chlorag+ard technology and TightTrack tunneler.
Arrow JACC...
First US commercial placements of Angel catheter
Bio2 Medical has announced that the Angel catheter, a new device for the prevention of pulmonary embolism, was placed in two patients at St...
