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Sorin Group has enrolled the first patient in the US investigational device exemption (IDE) study for its freedom solo stentless pericardial aortic...
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CardioFocus treats first US patient using HeartLight ablation system
CardioFocus has treated the first patient in the US pivotal trial intended to assess the safety and efficacy of the HeartLight endoscopic ablation system (EAS) in treating symptomatic...
ASI imaging for HER-2/neu analysis wins FDA approval
The US Food and Drug Administration (FDA) has cleared Applied Spectral Imaging's (ASI) GenASIs automated scanning and image analysis...
Asuragen introduces miRInform pancreatic assay
Asuragen has launched the miRInform pancreas test to aid clinicians in the diagnosis and management of pancreatic ductal adenocarcinoma (PDAC) when cytology is...
FDA approves Medtronic Resolute Integrity stent
The US Food and Drug Administration (FDA) has approved Medtronic's Resolute Integrity™ drug-eluting stent (DES), designed for the treatment of coronary artery disease...
REVA Medical initiates patient enrolment in RESTORE trial
REVA Medical has begun patient enrolment in Europe for the ReZolve™ sirolimus-eluting bioresorbable coronary scaffold RESTORE pilot study in addition to its primary site in Sao Paulo,...
Titan Medical, Columbia University to develop single port robotic surgery system
Titan Medical and Columbia University have entered into an exclusive licence agreement to develop and commercialise a novel single port robotic surgery system, The Insertable Robotic...
MicroCHIPS announces positive trial data for microchip-based drug delivery device
MicroCHIPS has announced the results of the first successful human clinical trial using an implantable, wirelessly controlled and programmable microchip-based drug delivery...
Gen-Probe prostate cancer assay gets FDA nod
The US Food and Drug Administration (FDA) has cleared Gen-Probe's PROGENSA® PCA3 (Prostate Cancer gene 3) assay, the first molecular test to help demonstrate the need for repeat...
Delcath chemosaturation system gets Australian regulatory clearance
The Therapeutic Goods Administration (TGA) division of the Australian government has approved Delcath Systems' Hepatic CHEMOSAT® delivery system for listing on the Australian Register...
CardioSCORE assay could detect patients at high risk of cardiovascular events
BG Medicine has announced positive results from the pivotal validation study of its CardioSCORE diagnostic blood test, which was formerly known as...
FDA clears AngioDynamics' NeverTouch Direct procedure kit
The US Food and Drug Administration has granted 510(k) clearance for AngioDynamics' NeverTouch Direct™ procedure kit for use with its VenaCure EVLT® laser vein ablation...
FDA clears Elekta Integrity R1.1 treatment control system
Elekta, a human care company, has received 510(k) clearance from the US Food and Drug Administartion for its Integrity R1.1 device, which has been found to improve the speed and performance...
Medtronic begins Symplicity renal denervation system trials
Medtronic has initiated two clinical programmes, SYMPLICITY-HF and Global SYMPLICITY Patient Registry, to demonstrate the clinical use of the company's Symplicity™ renal denervation system...
Forsyth, Quanterix, BIDMC to collaborate on TB test
Quanterix Corporation, a developer of new generation molecular diagnostic tests, will join forces with Forsyth Institute and Beth Israel Deaconess Medical Center (BIDMC), to develop an...
Smith & Nephew reports trial data of BHR implant
Smith & Nephew has announced the results of a new study conducted at The McMinn Centre in Birmingham, UK, evaluating the company's Birmingham Hip Resurfacing (BHR)...
Endologix completes patient enrolment in PEVAR trial
Endologix has concluded patient enrolment in the company's clinical trial of a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair...
Boston Scientific introduces TruePath CTO device in US
Boston Scientific has introduced the TruePath™ CTO device in the US, designed to facilitate the crossing of chronic total occlusions (CTOs, or complete blockages) within the...
PositiveID begins glucose monitoring device trial
PositiveID has begun a clinical trial of its Easy Check non-invasive breath glucose detection device, intended for use in people with...
Complete SE vascular stent found to treat atherosclerosis in SFA
Medtronic has reported the one-year results from an international study of the Complete self-expanding (SE) vascular stent, designed for the treatment of atherosclerosis in the superficial...
Boston Scientific introduces EUS aspiration needle
Boston Scientific has announced the global launch of the Expect 19 flex endoscopic ultrasound aspiration needle, used for acquiring tissue samples under endoscopic ultrasound (EUS) guidance...
