Medtronic posts positive 3-year data in renal denervation ahead of pivotal readout

Recent clinical trial results showed Medtronic's device reduced blood pressure out to three years, but analysts cautioned against using the results as a guide for the upcoming pivotal data.

By Nick Paul Taylor • April 5, 2022

iRhythm builds case for wearable cardiac monitor with data in fainting, TAVR patients

Data presented at ACC's Scientific Sessions show that by using iRhythm's Zio to monitor patients after discharge, physicians reduced hospital stays and potentially improved identification of arrhythmia.

By Nick Paul Taylor • April 4, 2022

US replaces EU as priority market for medtech industry: survey

A survey of more than 100 executives at medical device companies found 89% of medtechs plan to prioritize U.S. regulatory approval going forward. One CEO said the EU's Medical Device Regulation "is killing innovation."

By Nick Paul Taylor • March 16, 2022

Guardant Health targets colorectal cancer screening in 2022

CEO Helmy Eltoukhy tells MedTech Dive the precision oncology company plans to launch a liquid biopsy in the first half of the year, rivaling Exact Sciences' Cologuard stool test.

By Greg Slabodkin • Feb. 8, 2022

Edwards-backed Corvia fails pivotal heart failure trial but clings to subgroup efficacy signal

Corvia Medical's atrial shunt therapy has failed to improve cardiovascular disease outcomes in heart failure patients, according to clinical trial results. 

By Nick Paul Taylor • Feb. 2, 2022

FDA finalizes two guidances on including patient perspectives in medtech clinical trials

The documents, which elaborate on how to engage patients to improve trial design and use patient-reported outcomes, are based on feedback from groups like AdvaMed which raised concerns about "significant" legal issues.

By Nick Paul Taylor • Jan. 26, 2022

Exact Sciences posts positive data on Cologuard 2.0 ahead of readouts on rival tests

A study found Exact's second-generation stool test has a lower false positive rate than the current product and is better at detecting precancerous lesions. But it is facing competing blood tests from Freenome and Guardant Health.

By Nick Paul Taylor • Jan. 20, 2022

User growth, product delays and a Super Bowl ad: Diabetes tech heads into 2022 after another eventful year

Diabetes tech companies are heading into 2022 with momentum as insulin pump and CGM use climbs and with key product launches on the horizon. Here are MedTech Dive's top sector stories in 2021.

Dec. 28, 2021

Neurostimulator to treat stroke fails to gain FDA advisory panel support

The panel questioned whether modifications in the pivotal trial for the device from BrainsGate, a company that attracted early investment from Boston Scientific and J&J, could have compromised the study.

By Susan Kelly • Dec. 13, 2021

Vaccine makers move quickly to confront omicron threat

Several companies, including Pfizer and Moderna, are already at work adapting their coronavirus shots to the newly identified variant, which experts worry could more readily evade vaccine protection.

By Ned Pagliarulo • Nov. 29, 2021

FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country. 

By Ben Fidler • Nov. 19, 2021

Latest Abbott, Boston Scientific LAAC devices yield mixed results in first clinical comparison

No clear difference was evident in clinical outcomes at 45 days, but other endpoints did point toward potential pros and cons of the two left atrial appendage closure devices.

By Nick Paul Taylor • Nov. 8, 2021

Edwards, Medtronic bolster economic, clinical case for using TAVR over surgery

Medtronic released five-year data from the SURTAVI trial while Edwards presented a two-year study of the costs of TAVR and surgery, both of which were late-breaking clinical trials at the TCT annual scientific symposium.

By Nick Paul Taylor • Nov. 8, 2021

Siemens' Varian leads latest FDA breakthrough device designations

Varian secured the regulatory privileges for its noninvasive treatment of knee osteoarthritis based on technology acquired from Boston Scientific. Magnus Medical, Renovia and MY01 are included in the latest batch of designations.

By Nick Paul Taylor • Nov. 1, 2021

Medtronic surgical robotics head talks Hugo, taking on Intuitive, COVID-19 challenges

Megan Rosengarten spoke to MedTech Dive about challenging Intuitive Surgical's 20-year lead in soft tissue robotics, growing global robotics usage and the stress of entering a new market amid COVID-19.

By Ricky Zipp • Oct. 20, 2021

Medtronic misses bid for early FDA OK in renal denervation, stock slides

The independent data safety monitoring board found the clinical trial needs to keep enrolling patients and gather results to show if the treatment works.

By Nick Paul Taylor • Oct. 18, 2021

Spine devices, recalls and endovascular stents on FDA's fall meeting lineup

Other topics include Integra's bid for approval of a device used as soft tissue support in post-mastectomy breast reconstruction and a workshop on artificial intelligence and machine learning. 

By Nick Paul Taylor • Sept. 8, 2021

COVID-19 seems to skew Abbott heart failure monitor study results

The clinical trial of the CardioMEMS implantable sensor in a wider patient population missed its primary goal, but the company is moving forward based on an analysis adjusted for the pandemic.

By Susan Kelly • Aug. 30, 2021

Abbott's Amulet trial results could lift LAA closure market: analysts

Wall Street analysts were not surprised by the results given the recent FDA approval for Amulet, but agreed that the data was strong enough to boost the left atrial appendage closure products from Abbott and Boston Scientific.

By Nick Paul Taylor • Updated Aug. 31, 2021

'Evidence gaps' spur CMS to call meeting to discuss cerebrovascular devices

The agency said the "shorter term data with greater reliance upon intermediate and surrogate outcomes" used to bring devices to market is "generally less helpful" for its assessments.

By Nick Paul Taylor • Aug. 11, 2021

TransMedics stock halted in Nasdaq trading ahead of FDA advisory panel meeting

The company's stock price was down more than 5% at the close of trading on Tuesday. An FDA panel on Wednesday is evaluating data concerning the safety and effectiveness of TransMedics' device for preserving donor livers.

By Nick Paul Taylor • Updated July 14, 2021

Dexcom CEO on the Type 2 population, the Super Bowl ad and pandemic momentum

Kevin Sayer called Type 2 a "tremendous market opportunity" and said direct-to-consumer advertising is worth some controversy.

By Ricky Zipp • July 6, 2021

Roundup: Trial results, looming product releases fuel diabetes tech competition

In the first half of the year, the space is meeting Wall Street's high expectations for 2021. Here's a roundup of MedTech Dive's coverage of the market, including from this week's American Diabetes Association meeting.

June 30, 2021

Robotic abdominal surgery has no advantage over open, laparoscopic surgeries: meta-analysis

The review found of 39 studies reporting surgical complications, just 10% showed fewer complications with robot-assisted surgery. The analysis was published in the Annals of Internal Medicine.

By Greg Slabodkin • June 29, 2021

Medtronic smart insulin pen improved time in target blood glucose levels: study

The medtech giant's trial results come as competition in the space is intensifying. Eli Lilly and Bigfoot Biomedical, partnered with Abbott, are also prioritizing the technology.

By Ricky Zipp • June 29, 2021