FDA: Avoid paclitaxel-coated PAD devices for most patients

BD Thursday joined Medtronic in pushing back against the agency's findings, saying it stands behind the safety of the Lutonix drug-coated balloon.

By Susan Kelly • Updated March 22, 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

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

Intuitive's da Vinci SP gets FDA otolaryngology clearance

The approval is the second procedure category to be cleared for the da Vinci single port system, as the company looks to grow internationally.

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

Abbott gains expanded indication for MitraClip valve repair device

M&A has dominated the mitral space in recent years as structural heart competitors look to follow MitraClip's growth.

By Susan Kelly • March 15, 2019

FDA greenlights device for treating carbon monoxide exposure

The De Novo-winning Thornhill device accelerates a patient’s breathing rate to get poison out of the body.

By Nick Paul Taylor • March 15, 2019

Fresenius gets breakthrough status for hemodialysis software

The experimental software makes recommendations to improve fluid management and thereby cut the rate of complications.

By Nick Paul Taylor • March 15, 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

Stryker to spend up to $220M on rotator cuff tear tech

The Kalamazoo, Michigan-based medtech announced it has closed a deal with Israeli startup OrthoSpace, which formerly drew investment from Johnson & Johnson and Smith & Nephew.

By Maria Rachal • March 14, 2019

HemoSonics gets De Novo nod for POC coagulation device

The test uses ultrasound to quickly analyze blood samples at the point of care.

By Nick Paul Taylor • March 14, 2019

Navigating FDA's evolving device pathways: A primer

The agency is touting the biggest alterations to medtech approval processes in the decades since it began reviewing devices. Here's a roundup of the current regulatory framework and what's potentially changing.

By Meg Bryant • March 13, 2019

FDA qualifies test for traumatic brain injury

The OsiriX CDE test can now be used by medical device developers to identify and enroll patients in studies of TBI, which has been researched for years but has no effective treatment.

By Susan Kelly • March 13, 2019

Smith & Nephew buys skin substitute maker for $660M

The company announced Wednesday it closed the acquisition of Osiris Therapeutics. 

By Susan Kelly • Updated April 17, 2019

Hill-Rom strikes $180M Voalte takeover to boost connected care unit

The acquisition will give the hospital equipment maker a communications system to complement its portfolio of smart devices.

By Nick Paul Taylor • March 13, 2019

Omada adds connected blood pressure cuff, glucometer to health program

The devices will enable participants in the digital health platform's disease prevention and management program to collect and share data.

By Nick Paul Taylor • March 13, 2019

Diagnostic errors compounded by EHRs No. 1 safety fear: ECRI

"We have to recognize the limits of current technology and ensure that we have processes in place to close the loop on diagnostic tests," the medical device watchdog's William Marcella said.

By Meg Bryant • March 12, 2019

NCI Director Ned Sharpless to be named FDA acting commissioner

Sharpless will succeed FDA Commissioner Scott Gottlieb in early April. He has served as director of the National Cancer Institute since October 2017.

By David Lim , Maria Rachal • Updated March 12, 2019

Intrathecal drug delivery system wins FDA breakthrough designation

The accelerated review status follows Alcyone's announcement of a strategic collaboration with Roche to develop treatment options for patients with neurological disorders.

By Susan Kelly • March 12, 2019

Edwards deepens structural heart position with new investments

Deals with Corvia Medical and Mitralign could bolster the valve specialist's structural heart treatment abilities, where the company said it intends to remain focused.

By Susan Kelly • March 12, 2019

FDA digital health efforts highlighted in Trump budget

The blueprint calls for Medicare coverage for breakthrough devices.

By David Lim • March 12, 2019

UK to probe safety of paclitaxel cardiovascular devices

The investigation will review data linking drug-coated balloon catheters and drug-eluting stents to increased death rates, including studies of those sold by Boston Scientific, Cook Medical, C.R. Bard, Medtronic and others.

By Nick Paul Taylor • March 12, 2019

FDA flags surgical stapler risks, plans advisory meeting

The agency alerted healthcare providers to an increasing number of medical device reports associated with use of surgical staplers, including at least 366 deaths and more than 9,000 serious injuries.

By Susan Kelly • March 11, 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

AdvaMed raises concerns with FDA's proposed De Novo model

In comments on FDA's proposed De Novo classification rule, the medical device lobby said it is concerned the framework would impose some requirements that replicate the premarket approval application review.

By Susan Kelly • March 11, 2019

CMS updates 2021 DME bidding round plans, adds new product categories

The American Association for Homecare argued addition of non-invasive ventilators to the competitive bidding program will drive companies out of business.

By David Lim • March 11, 2019