Label should warn patients of paclitaxel device mortality signal, FDA panel says

The advisory committee struggled through the two-day meeting evaluating the safety of the devices due to incomplete data. Members agreed more data is needed but differed on the method the agency should use to collect it.

By David Lim • June 21, 2019

As CMS decision on TAVR looms, a push for broader access

Proposed agency rules would lower the bar for hospitals performing the less invasive heart procedure, but would also raise the eligibility requirements to offer the treatment.

By Nick Paul Taylor • June 18, 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

Beta Bionics, Insulet seek shake-up of insulin delivery market at ADA

Data presented at the American Diabetes Association meeting move the companies a step closer to challenging Medtronic and Tandem.

By Nick Paul Taylor • June 11, 2019

Device interoperability, CGM for Type 2 patients among ADA 2019 standouts

More options for automated insulin dosing systems are emerging, particularly as FDA established new device classifications for interoperable pumps and glycemic controller algorithms via the De Novo pathway.

By Maria Rachal • June 10, 2019

Abbott and Tandem in the spotlight at diabetes meeting

Abbott is sharing details of its FreeStyle Libre 2 CGM system, and Tandem is presenting data on its automated insulin delivery system.

By Nick Paul Taylor • June 7, 2019

Philips' 3-year data links drug-coated balloon to sustained benefits

The company's low-dose paclitaxel-coated Stellarex beat or matched uncoated balloons on key endpoints, including rates of primary patency and mortality.

By Nick Paul Taylor • May 30, 2019

Edwards presents 6-month data on Pascal, eyeing MitraClip

The structural heart giant's CE-marked system showed sustained mitral regurgitation improvement in patients. The company is gearing up for a head-to-head trial against Abbott's device, which is the only FDA-approved option.

By Maria Rachal • May 23, 2019

FDA wants new companies to help test its Pre-Cert Program

One pilot company's CEO told MedTech Dive FDA's search for new companies "is not a surprise to us" and "is a really good thing for the Pre-Cert program."

By David Lim • May 23, 2019

Medtronic results build case for renal denervation device

One study linked Symplicity to a reduced occurrence of subclinical atrial fibrillation in a subset of high-risk patients.

By Nick Paul Taylor • May 23, 2019

Biotronik stent bests Medtronic in study of small-vessel lesions

Evidence from a sub-group analysis of a three-year clinical trial supports the theory that stents with very thin struts are less likely to require repeat revascularization in patients.

By Nick Paul Taylor • May 22, 2019

J&J's Auris unveils early results on Monarch robot for lung procedures

The FDA-cleared robotic platform successfully localized lung nodules in 92% of patients, Auris Health reported at the American Thoracic Society Conference.

By Susan Kelly • May 21, 2019

Titan Medical's losses balloon as robotic surgery R&D drive accelerates

The company plans to file for a CE mark and 510(k) clearance for its robotic surgery platform by the end of the fiscal year. It aims to start early U.S. commercialization in 2020.

By Nick Paul Taylor • May 16, 2019

Medtronic posts data on stent grafts and venous closure systems

The endosuture aneurysm repair and chronic venous disease data suggest the efficacy seen earlier in the studies is durable.

By Nick Paul Taylor • April 18, 2019

Pfizer, Concerto collaborate on AI in precision oncology

The agreement is Concerto's second AI collaboration with a big pharma company in recent weeks and will focus on identifying new treatment options, refining study designs and speeding completion times for outcome studies.

By Susan Kelly • April 10, 2019

TAVR called 'game changing' in studies of low-risk patients

Data from Edwards Lifesciences' Partner 3 trial and Medtronic's Evolut Low Risk study prompted predictions that TAVR will become the preferred option for a wider population of heart valve patients.

By Susan Kelly • March 18, 2019

Apple heart study: Early proof of concept, or a gimmick?

Doctors at the American College of Cardiology meeting said the Apple Watch's foray into health monitoring needs more data to prove its value. 

By David Lim • March 16, 2019

Apple, Medtronic and more medtech to track at ACC19

Anticipated data backing the tech giant's heart rhythm-tracking watch, results from Medtronic and Edwards aimed at broader use of TAVR procedures, and an update on Abbott's MitraClip highlight the annual conference.

By Maria Rachal • March 14, 2019

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