TAVR for low-risk patients in spotlight at ACC

Jefferies analysts predict results from valve makers Edwards Lifesciences and Medtronic will "usher in the low risk era for TAVR," expanding the market for the devices.

By Susan Kelly • March 11, 2019

Tandem suspends software use in pivotal closed loop study to fix bug

The company sought to quell nerves, but investors pushed the stock down 8% on safety concerns.

By Nick Paul Taylor • March 7, 2019

Medtronic says corrected IN.PACT analysis to be published in JACC

The revision, prompted by a data error, complicates an already contentious debate about long-term safety of drug-coated balloons in treating peripheral artery disease.

By Susan Kelly • March 4, 2019

Liquid biopsy as effective as tissue biopsy in lung cancer, study finds

A clinical trial found Guardant Health's test detected advanced non-small cell lung cancer at a similar rate to traditional tissue-based biopsies.

By Emily Mullin • March 1, 2019

Boston Scientific Lotus matches Medtronic CoreValve in head-to-head TAVR trial

The readout comes as Boston Scientific prepares to introduce its device in the U.S. and Europe.  

By Nick Paul Taylor • Feb. 28, 2019

Myriad plans companion diagnostic filing as PARP drug clears clinical test

The company said Thursday its BRACAnalysis CDx diagnostic will be used to find germline BRCA mutations in men with certain prostate cancers in a Phase 3 study.

By Nick Paul Taylor • Updated April 4, 2019

Biotronik's drug-eluting stent expands to US market with PMA

The Orsiro system for coronary artery disease will play against Abbott's Xience and Medtronic's Resolute.

By Maria Rachal • Feb. 25, 2019

FDA rule on device study practices comes into force

The final rule mandates the use of good clinical practices by sponsors of trials based outside the U.S.

By Nick Paul Taylor • Feb. 22, 2019

FDA panel backs vaginal mesh option, wants more data

The agency will consider recommendations from the obstetrics and gynecology devices panel as it makes decisions on premarket approval applications from Boston Scientific and Coloplast.

By Maria Rachal • Updated Feb. 14, 2019

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