CMS eases study parameters in depression device coverage decision

LivaNova seeks to enroll clinical trial patients beginning in the third quarter of 2019. Those patients will only need to demonstrate response rather than remission, per CMS updates to the finalized decision memo.

By Maria Rachal • Updated Feb. 19, 2019

FDA sets neurology, microbiology device panel meetings for March

Advisory committees will discuss a De Novo application for an Alzheimer's therapy and new approaches to evaluate HPV screening devices.

By Maria Rachal • Jan. 31, 2019

LivaNova highlights studies into efficacy, value of sutureless aortic valve

The research suggests the valve, Perceval, may have advantages over competing technologies. 

By Nick Paul Taylor • Jan. 18, 2019

Regulatory makeovers and international game changers: MedTech Dive's top stories of 2018

Hard looks at cybersecurity and digital health's hot streak also left their mark on the year.

By Maria Rachal • Dec. 22, 2018

Bayer, FDA lengthen Essure postmarketing study to 5 years

The German pharma announced in July it would no longer sell the birth control implant in the U.S. due to falling sales.

By David Lim • Dec. 21, 2018

FDA outlines fast track vision for breakthrough devices

The agency also announced plans to establish a pathway for devices aimed at treating non-life-threatening diseases not eligible for the original program.

By David Lim • Dec. 18, 2018

Novartis, Pear move digital schizophrenia drug into Phase 2

The trial will assess whether behavior therapy software can improve the symptoms of people with schizophrenia.

By Nick Paul Taylor • Dec. 18, 2018

BioSig partners with Mayo Clinic for electrophysiology recording system trial

BioSig thinks the technology improves on systems sold by companies like Abbott and Boston Scientific.

By Nick Paul Taylor • Dec. 7, 2018

Patient perspective missing in device clinical trials, FDA says

Studies of medical devices have struggled to recruit and retain participants and meaningfully communicate findings to patients, prompting FDA to seek feedback for a draft guidance on developing better patient-centered studies.

By Maria Rachal • Nov. 27, 2018

Vectura asthma drug-device combo fails in Phase 3 study

As a result, the pharma will abandon VR475 but carry on with another candidate and three early-stage nebulization programs.

By Andrew Dunn • Nov. 26, 2018

CMS gives mixed ruling on LivaNova depression device

A big market opportunity awaits the U.K. device maker if Medicare moves to cover the vagus nerve stimulation device for hard-to-treat depression after a required clinical trial.

By Maria Rachal • Nov. 21, 2018

Cardiva's vascular closure system cuts patient recovery times in study

The findings precede an anticipated FDA decision on a premarket approval application for the company's system for multi-vessel closure.

By Nick Paul Taylor • Nov. 13, 2018

BD posts long-awaited clinical data on Lutonix balloon in CLI

If the approval and commercialization go to plan, BD thinks the below-the-knee opportunity is worth about $250 million a year.

By Nick Paul Taylor • Nov. 8, 2018

Genentech releases more data on refillable eye implant

Study results showed that vision and anatomical outcomes in wet AMD patients who received the device, and dosed every six months or longer, were comparable to ranibizumab dosed every four weeks.

By Susan Kelly • Oct. 30, 2018

Myriad's BRCA test supports successful ovarian cancer trial

The molecular diagnostics company plans to file to expand use of the genetic test.

By Nick Paul Taylor • Oct. 23, 2018

Abbott medical device, diagnostic units drive Q3 growth

CEO Miles White said Abbott plans to submit its data to FDA in the coming weeks to back an expanded indication for MitraClip.

By David Lim • Oct. 17, 2018

FDA takes aim at lack of pediatric devices

"Funding is a huge challenge because of the inherently small market," Reed McCarty, co-founder and partner at SandBox Medical, told MedTech Dive.

By Meg Bryant • Oct. 8, 2018

Prostate cancer imaging agent meets one of two study endpoints

The results mark Progenics Pharmaceuticals' second clinical trial for a prostate cancer imaging agent to show mixed results in as many months.

By Susan Kelly • Oct. 8, 2018

Karius posts clinical data on heart infection test

The test identified the pathogen affecting one of the three patients failed by traditional methods.

By Nick Paul Taylor • Oct. 5, 2018

5 themes from The MedTech Conference

Mergers and acquisitions, digital health, FDA pilot programs and Netflix's The Bleeding Edge were among the hot topics in Philadelphia.

By David Lim , Kim Dixon • Oct. 1, 2018

Medtronic CoreValve proves durable in longer-term data

Severe hemodynamic structural valve deterioration was 0.8% for CoreValve versus 1.8% for surgery across five years, with similar rates of mortality and major stroke in both patient samples.

By Susan Kelly • Sept. 25, 2018

Boston Scientific's Eluvia wins FDA nod, seen as effective as Cook's Zilver in study

Results of the first head-to-head clinical trial to compare the two drug-eluting stents to treat leg artery blockages were presented at a scientific meeting this weekend. On Monday, the FDA cleared the Boston device.

By Susan Kelly • Sept. 24, 2018

Medtronic heart stent works as well as thin-strut Orsiro: study

The device giant's Resolute Onyx coronary stent was found to be as effective and safe as the Orsiro ultra-thin-strut stent made by privately held Berlin-based Biotronik.

By Susan Kelly • Sept. 24, 2018

Abbott's MitraClip keeps more heart valve patients alive in study

The device for minimally invasive repair of the mitral heart valve in patients with advanced heart failure and severe mitral regurgitation significantly reduced both hospitalizations and mortality.

By Susan Kelly • Sept. 24, 2018

Medtronic to study TAVR in low-risk bicuspid patients

FDA also approved a revised label for the Evolut valve that removes a precaution for patients with aortic stenosis at intermediate or greater mortality risk from surgical aortic valve replacement.

By Susan Kelly • Sept. 19, 2018