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Clinical / R & D

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Another Study Casts Doubt Over Off-Pump CABG Benefits

Five-year mortality and major morbidity results from a large randomized trial run by the Veterans Affairs found no advantages to so-called off-pump "beating heart" coronary bypass graft surgery over traditional on-pump bypass surgery in which the patient is supported by a cardiopulmonary bypass machine.

Cardiology Surgery Clinical Trials
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Clinical Trials

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Latest From Clinical Trials

Expanding The Medtech Toolbox: US FDA's 'Medical Device Development Tools' Program Rolls Out

Three years in the making, FDA has released a final guidance for medical device development tools that would allow developers to qualify their MDDTs and give medical device manufactures access to new tools that could help them prove safety and effectiveness of their products sooner.

Regulation Clinical Trials

PMA Supplement Studies Weak, Study Finds, As Past FDA Chief Califf Calls For More Rigor

The quality of studies used to support panel-track PMA supplement approvals need upgrading, as fewer than half were randomized, blinded or controlled and many relied on surrogate endpoints, says a study published in JAMA. In an accompanying editorial, former FDA commissioner Robert Califf, says it "raises concerns" that the US regulatory system has gotten "too permissive."

Clinical Trials Regulation

Abbott Launches Feasibility Trial Of Tricuspid Version Of MitraClip

The TRILUMINATE trial will evaluate safety and effectiveness of its Tricuspid Valve Repair System for treating symptomatic moderate-to-severe tricuspid regurgitation. The device is similar to Abbott's successful MitraClip catheter-based device for treating mitral regurgitation.

Clinical Trials Innovation
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New Technology

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Latest From Innovation

UK Viewpoint: AHSNs, AAR And Accelerators – Market Access & Innovation Update

Dr Charlie Davie, managing director of UCLPartners, a London-based Academic Health Science Partnership and one of the 15 UK Academic Health Science Networks, updates Medtech Insight on key changes in NHS market access policy this summer.

United Kingdom Market Access

Start-Up Spotlight: LimFlow, Endovascular Treatment For End-Stage Critical Limb Ischemia

French start-up LimFlow is developing a percutaneous deep vein arterialization system, designed for installing a stent-graft that shunts blood from a diseased tibial artery into a tibial vein to revascularize the foot of a patient with severe peripheral artery disease.

Diabetic Care Wound Management

OUS Approvals: Cardiovascular Devices Lead Modest List In July

July 2017 brought 26 approvals from outside the United States, including 14 CE marks in Europe and 12 from five other territories. Almost half of the approvals were for cardiovascular devices; the rest came from eight other categories.

Approvals Innovation
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Approvals

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Latest From Approvals

OUS Approvals: Cardiovascular Devices Lead Modest List In July

July 2017 brought 26 approvals from outside the United States, including 14 CE marks in Europe and 12 from five other territories. Almost half of the approvals were for cardiovascular devices; the rest came from eight other categories.

Approvals Innovation

Over 170 Provisional Draft Codes Published For Notified Body Designation Under MDR & IVDR

Three new draft documents relating to notified bodies list the codes being prepared to determine their scope of responsibility for designation under the new EU medtech regulations and the raft of documentation they will be asked to submit when they apply for redesignation.

Approvals Compliance

US Approvals Analysis: Drug-Coated Balloon, Valve Tech Are July Highlights

July was a relatively light month for novel-device approvals by US FDA, but year-to-date volumes remain strong. Spotlighted devices include approval of a new drug-coated balloon and heart valve devices. Here's a roundup from Medtech Insight's Approval Tracker.

Approvals Innovation
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