FDA finalizes guidance on HDEs after AdvaMed scrutiny

Industry advocates had criticized FDA's tight parameters on which humanitarian use devices are eligible to turn a profit, but the final guidance largely mirrors the draft.

By Susan Kelly • Sept. 6, 2019

Racing Edwards, Abbott starts pivotal trial of tricuspid device

The product, a sibling of MitraClip, could become the first transcatheter tricuspid device of its kind on the U.S. market.

By Nick Paul Taylor • Sept. 6, 2019

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

FDA floats idea for assessing the risk-benefit profile of weight-loss devices

Concerned that some patients lack access to effective weight-loss devices, the agency is seeking feedback to inform guidance that it says will help device developers offer a wider variety of tools.

By Nick Paul Taylor • Sept. 6, 2019

Livongo posts 'good enough' first earnings since IPO, but stock tanks

The digital health company beat analysts' revenue targets, but a greater-than-expected loss on earnings per share contributed to a double-digit hit to its stock price in morning trading.

By Maria Rachal • Sept. 5, 2019

With partner iRhythm, Verily ramps up AFib efforts

iRhythm committed almost $18 million to Verily to boost development of technology that helps deliver earlier warnings to individuals with asymptomatic or silent atrial fibrillation.

By Maria Rachal • Sept. 5, 2019

Robotic tech used for cardiac intervention from 20 miles away

Patients were treated remotely using telerobotic technology from Corindus, which was recently acquired by Siemens Healthineers.

By Nick Paul Taylor • Sept. 5, 2019

More Blue Cross plans now covering Senseonics' implantable glucose monitor

The medtech recently snagged a new positive coverage decision from Health Care Services Corporation, the nation's fourth largest insurer, which operates Blue Cross Blue Shield plans covering 16 million members across five states.

By Nick Paul Taylor • Updated Oct. 15, 2019

Tool to bust coronary plaque with sonic waves wins FDA breakthrough nod

Shockwave Medical, which went public in March, is enrolling patients in a pivotal trial to study the device in treating cardiovascular disease. Abiomed is among its backers.

By Susan Kelly • Sept. 4, 2019

Stryker spends up to $500M to boost spine unit with imaging, robotics tech

The medtech said Monday it completed its buy of Mobius Imaging, which makes a mobile CT scanner, and Cardan Robotics, which develops radiology procedure technologies. 

By Maria Rachal • Updated Oct. 21, 2019

Biotronik's Orsiro stent beats Abbott's Xience in head-to-head trial

The trial linked the "ultrathin" Orsiro to a lower rate of target lesion revascularization than Abbott's incumbent device.

By Nick Paul Taylor • Sept. 4, 2019

FDA sets November ethylene oxide sterilization, duodenoscope safety advisory panel

The dual-topic expert panel will be tasked with developing recommendations for FDA on two of the largest challenges currently facing the Center for Devices and Radiological Health.

By David Lim • Sept. 3, 2019

Weight-loss surgery for Type 2 diabetes could cut major heart risks, study suggests

Published in JAMA and funded by Medtronic, results from the retrospective study have yet to be confirmed by randomized clinical trials.

By Maria Rachal • Sept. 3, 2019

Regulators put out call for experts to join device advisory committees

FDA is seeking people to sit on 18 panels that review medical device data and manufacturing regulations.

By Nick Paul Taylor • Sept. 2, 2019

FDA urges providers, manufacturers to transition to duodenoscopes with disposable parts

Boston Scientific told investors last year single-use duodenoscopes represent a market opportunity of more than $1 billion dollars.

By David Lim • Aug. 30, 2019

Summer slowdown drags on for De Novos

The FDA has not announced a De Novo clearance in 12 weeks. Two-thirds of the way through 2019, pacing suggests the overall number of novel device approvals won't match 2018's high.

By Maria Rachal • Aug. 30, 2019

McKesson, Philips devices flagged by DHS for cyber vulnerabilities

Certain cardiovascular IT systems and ultrasound devices could be exploited by hackers, the Department of Homeland Security wrote in separate notices.

By Nick Paul Taylor • Aug. 30, 2019

AdvaMed wins some, loses some in FDA guidance on managing uncertainty

While the agency tweaked parts of the document in line with feedback from AdvaMed and other groups, it maintained its plan to hold advisory committee meetings on certain postmarket data and kept other contested proposals.

By Nick Paul Taylor • Aug. 30, 2019

Medline, Vantage ethylene oxide emissions caused cancer, lawsuits claim

Commercial sterilizer Sterigenics, which was forced to shut down a Willowbrook medical device sterilizing plant in February, is defending itself against at least 32 lawsuits in the same state court over similar claims.

By David Lim • Aug. 29, 2019

Surmodics passes milestone in trial of Abbott-licensed paclitaxel-coated balloon

Surmodics completed enrollment sooner than some analysts expected on a trial comparing its paclitaxel-coated balloon to Medtronic's IN.PACT Admiral.

By Nick Paul Taylor • Aug. 29, 2019

Elekta buys ProKnow to boost digital radiotherapy strategy

The Swedish company says ProKnow's capabilities are of particular value to its large customers, potentially helping give it an edge over rivals such as Varian Medical Systems.

By Nick Paul Taylor • Aug. 29, 2019

Life Spine talks up global expansion weeks after DOJ hit

The micro invasive spine tech maker says its products are now sold in 30 countries, including recent additions in South America.

By Nick Paul Taylor • Aug. 29, 2019

Medtronic's Ishrak set to retire after nearly decade as CEO

The leadership shuffle paves the way for Restorative Therapies Group head Geoff Martha, who led Medtronic's nearly $43 billion takeover of Covidien in 2014, to take the helm in time for the medtech giant's next fiscal year.

By Maria Rachal • Aug. 28, 2019

AtriCure gets expanded FDA label for atrial exclusion device

AtriCure said it has strong growth from the AtriClip FLEX.V device and is confident growth rates for appendage management products will continue.

By Nick Paul Taylor • Aug. 28, 2019

FDA approves pediatric spine device via humanitarian pathway

The device is a less invasive alternative to spinal fusion for adolescents with idiopathic scoliosis.

By Nick Paul Taylor • Aug. 28, 2019

Titan Medical delays 510(k) submission until 2020 amid cash burn concerns

The company plans to use the delay to spread out its spending while working to implement the robotic surgery system's sterile instrument interface components, software improvements and training tools.

By David Lim • Aug. 27, 2019