Tag: US FDA

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...
RapidAI

RapidAI receives FDA 510(k) clearance for PE Triage & Notification

RapidAI announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Rapid PE Triage & Notification product for...

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...

FDA approves two paediatric venous thromboembolism indications for Janssen’s Xarelto

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced that the US Food and Drug Administration (FDA) has approved two paediatric indications for...
Geko

Sky Medical receives FDA clearance to market the Geko device for...

Sky Medical Technology recently announced US Food and Drug Administration (FDA) 510(k) clearance to market the Geko device for increasing microcirculatory blood flow in...

Venclose Maven earns FDA clearance to treat incompetent perforator veins

Venclose recently announced US Food and Drug Administration (FDA) 510(k) clearance for Venclose Maven, a novel radiofrequency (RF) ablation catheter for minimally invasive treatment...

Koya Medical secures first reimbursement codes for Dayspring compression system, announces...

Koya Medical recently announced that its wearable, active compression therapy system for lymphoedema—Dayspring—has been issued new billing codes by the Center of Medicare &...
fist assist fa-1 device

Fist Assist device for focal arm massage and increased vein circulation...

Fist Assist Devices has received US Food and Drug Administration (FDA) 510(k) clearance for use of the Fist Assist FA-1 device in the USA...

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...
Zilver Vena

Zilver Vena venous self-expanding stent receives FDA approval to market in...

Cook Medical today announced that the Zilver Vena received US Food and Drug Administration (FDA) premarket approval (PMA) in the USA. The product is...

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...
bluegrass vascular trial results

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...

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...
shutdown

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...

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)...
LimFlow

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....
Venous News for specialists

US FDA approves betrixaban anticoagulant for hospital and extended duration prophylaxis...

The US Food and Drug Administration (FDA) has approved betrixaban (Bevyxxa, Portola), the first and only anticoagulant for hospital and extended duration prophylaxis (35...
Robert Califf with Venous News

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...
Powdered gloves must be replaced by non-powdered alternatives, following the ban

US FDA bans powdered gloves

The US Food and Drug Administration (FDA) has issued a final rule to ban powdered surgical gloves, patient examination gloves and the absorbable powder...
NICE’s Scientific Advice programme will work with companies looking to attain both FDA approval and payer coverage

NICE collaborates with US FDA on Payer Communication Taskforce

The UK’s National Institute for Health and Care Excellence (NICE) has announced its participation in the US Food and Drug Administration (FDA)’s Payer Communication...