Zimmer gets 510(k) clearance for Persona Revision knee

The device maker is counting on new products to speed a turnaround effort that saw the company notch its best growth in three years in the second quarter.

By Susan Kelly • Sept. 10, 2019

AI in medtech: Innovating in an era of uncertainty

The FDA clearance of a new AI technology empowers PCPs to better care for their diabetic patients, but what are the broader-reaching implications for AI innovators?

By Kate Templeton & Sundeep Karnik • Sept. 10, 2019

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Doubt cast on value of Exact Sciences' Cologuard

Research commissioned by CMS found the test is "less effective and considerably more costly" than other colorectal cancer screening methods.

By Nick Paul Taylor • Sept. 10, 2019

Boston Scientific says Biocardia doesn't own women's health patents, denies stealing trade secrets

Boston Scientific is asking a court to determine it didn't steal BioCardia's trade secrets and to clear up patent ownership of an early-detection diagnostic tool for ovarian cancer it acquired when it purchased nVision.

By Dana Elfin • Sept. 9, 2019

Medtronic touts new data on DCB in dialysis patients

The IN.PACT drug coated balloon received an expanded CE mark indication in January 2016 to treat AV access for patients with end-stage renal disease.

By David Lim • Sept. 9, 2019

Hospital buying data point to TAVR surge in Q3: analysts

Use of Edwards Lifesciences' systems is accelerating sharply in the third quarter, according to a Jefferies model, suggesting hospitals anticipated a recent FDA decision expanding the procedure's indicated population.

By Susan Kelly • Sept. 9, 2019

Pulmonary arterial hypertension device wins FDA breakthrough designation

Tel Aviv-based SoniVie's device is an ultrasound catheter inserted into the pulmonary artery in a right heart procedure to ablate nerves associated with disease activity.

By Susan Kelly • Sept. 9, 2019

FDA finalizes guidance for accepting De Novo requests

In the guidance, the agency explains procedures and criteria for assessing whether a device manufacturer's De Novo classification request should be accepted for a substantive review.

By Susan Kelly • Sept. 9, 2019

Telemedicine CEO pleads guilty in $424M Medicare kickback scheme

The executive admitted to seeking and getting bribes from patient recruiters, pharmacies and brace suppliers in return for arranging for doctors to order medically unnecessary orthotic braces.

By Dana Elfin • Sept. 9, 2019

Axonics wins PMA for sacral neuromod system, challenging Medtronic

The FDA approval allows the medtech to market its implantable, rechargeable device for treatment of fecal incontinence as it seeks further indications for overactive bladder and urinary retention.

By Maria Rachal • Sept. 9, 2019

NESTcc 1.0 aims to launch, be able to take unsolicited projects by end of year

The National Evaluation System for health Technology Coordinating Center Task Force is also currently developing an active surveillance roadmap it aims to issue for public comment this fall.

By David Lim • Sept. 6, 2019

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

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