LivaNova loops Verily into depression device study

A clinical trial meant to support CMS coverage of the U.K. medtech's vagus nerve stimulation system will incorporate a wearable device and phone app from Alphabet's life sciences research organization.

By Maria Rachal • Feb. 27, 2020

Medtronic faces key test in establishing US market for renal denervation

After a setback six years ago, the medtech giant is set to unveil pivotal trial data next month on a procedure to lower blood pressure. Abbott and Boston Scientific are likely watching closely.

By Susan Kelly • Feb. 10, 2020

Abiomed, on defense, plans wave of trials to counter Impella criticism

The maker of the heart pump is seeking to quash doubts after two large observational studies suggested the product was more risky and pricey than alternative treatments.

By Nick Paul Taylor • Feb. 6, 2020

5-year Edwards results: TAVR matches surgery on survival, but repeat hospitalizations more common

Separately, a pair of cardiologists in an editorial published this week in the journal Circulation noted potential "important differences" between Edwards' Sapien 3 and Medtronic’s CoreValve devices.​

By Nick Paul Taylor , Maria Rachal • Jan. 30, 2020

Abiomed device controversy revived in Circulation editorial

Experts flagged key limitations in a study suggesting the Impella device is pricier and more dangerous than intra-aortic balloon pumps, and highlighted an "urgent need" for randomized clinical trials.

By Nick Paul Taylor • Jan. 29, 2020

After subdued year for new spinal cord stim tech, industry seeks 2020 rebound

Medtronic, Abbott, Boston Scientific and others that presented at the North American Neuromodulation Society meeting hope an influx in new products will help restore market growth.

By Maria Rachal • Jan. 27, 2020

Study of Abbott's HeartMate 3 points to single treatment indication for LVADs

A study in JAMA Cardiology suggests it's unnecessary to group heart failure patients by transplant eligibility, which one cardiologist said could allow physicians to sidestep difficult upfront decisions about transplants and pumps.

By Nick Paul Taylor • Jan. 16, 2020

FDA OKs Abbott clinical trial of MitraClip in moderate risk patients

The transcatheter mitral valve repair device, used to treat primary mitral regurgitation, is currently only indicated for patients at a prohibitive risk for surgery. 

By David Lim • Jan. 13, 2020

Study links paclitaxel devices to better survival in PAD, muddying debate

New research comes about six months after FDA held an advisory panel in response to a meta-analysis that found an increased risk of death associated with the use of coated balloons and stents in an artery of the lower limbs.

By David Lim • Jan. 9, 2020

The MedTech Dive Awards of 2019

From TAVR's takeoff to FDA's new approaches to premarket review, these are the industry forces that left their mark on medical technology this year.

Dec. 9, 2019

Boston Scientific afib device effective in reducing stroke

Authors in the Journal of the American College of Cardiology said the rate of hemorrhagic stroke observed in left atrial appendage closure device registries is the lowest identified in the nonvalvular atrial fibrillation population.

By Nick Paul Taylor • Dec. 5, 2019

MRI screening linked to improved detection of breast cancer

The New England Journal of Medicine study found fewer cases of cancer are missed when MRIs are performed. At the same time, the scans come with a high rate of false positives, calling the utility of additional imaging into question.

By Nick Paul Taylor • Dec. 2, 2019

In stents v. statin debate, analysts call potential impact of ISCHEMIA trial overhyped

The study seemed to favor a conservative approach to treating stable heart disease. But many sell-side analysts called results expected, predicting they won't meaningfully hurt sales for device makers like Boston Scientific.

By Maria Rachal • Nov. 18, 2019

J&J reports rising success rate in robotic surgery clinical trial

The study is assessing diagnostic abilities of the Monarch robotic surgery platform, which Johnson & Johnson gained in the $3.4 billion acquisition of Auris Health.

By Nick Paul Taylor • Oct. 24, 2019

Experimental cancer IVD trial guidance finalized

AdvaMed won many many of the changes it sought during the comment period, including ones related to communication with the FDA.

By Nick Paul Taylor • Oct. 10, 2019

Intersect ENT misses endpoint on chronic sinusitis DCB, sending shares down

The company is "disappointed" the steroid delivery device, which it hopes to submit for premarket approval to FDA, did not prove superior on frontal sinus patency at 30 days when randomized against an uncoated balloon.

By Maria Rachal • Oct. 7, 2019

Edwards shows improved quality of life, durability of TAVR systems in trio of studies

Among other data presented over the weekend at TCT, Boston Scientific's in-development Acurate Neo TAVR system failed to meet a non-inferiority goal on safety and efficacy when compared to Edwards' Sapien 3.

By Susan Kelly • Sept. 30, 2019

Abbott's MitraClip outperforms medical therapy in study at 3 years

In addition, a group of patients that began the study on medical therapy and crossed over to the MitraClip at two years saw benefits matching those who received the device from the start.

By Susan Kelly • Sept. 30, 2019

Medtronic, Boston Scientific share data on stents with short-course antiplatelet therapy

The clinical trials provide data supporting the use of shorter regimens in coronary stent patients.

By Nick Paul Taylor • Sept. 27, 2019

Boston Scientific and Medtronic devices match on safety in 3-year TAVR trial

The Boston Scientific-backed trial found a similar rate of all-cause mortality between the two systems. Boston's device beat Medtronic's on rate of disabling stroke, but had more patients receiving a new pacemaker.

By Nick Paul Taylor • Sept. 26, 2019

FDA tries to spur patient shaping of clinical trial design with draft guidance

"Patient experiences and insight can help us understand the benefits most important to patients and what risks patients may or may not be willing to tolerate," acting FDA Commissioner Ned Sharpless said in a statement.

By Nick Paul Taylor • Sept. 24, 2019

Adaptive lands deal to provide NGS-based cancer tests to Amgen

The giant biotech will pay annual development fees, sequencing payments and regulatory milestones that could amount to a notable source of revenue for Adaptive.

By Nick Paul Taylor • Sept. 19, 2019

Mesh as good as hysterectomy for prolapse, 3-year NIH data suggests

The latest clinical trial outcomes appear in JAMA five months after FDA said mesh manufacturers had failed to prove adequate safety and effectiveness of the devices in patients with pelvic organ prolapse.

By Maria Rachal • Sept. 18, 2019

Apple to start trio of research studies on hearing, heart and women's health

The studies, which will be organized through a new Apple Research app this fall, are being conducted in partnership with various universities, hospitals, associations and the U.S. government.

By David Lim • Sept. 11, 2019

Physicians push FDA to shed light on device comparators

In a paper published in JAMA Network Open on Wednesday, physicians analyzed evidence used in the authorizations of products under the Humanitarian Device Exemption pathway.

By Nick Paul Taylor • Sept. 11, 2019