FDA, ECRI, device group keep up drumbeat on cybersecurity risks

The agency is launching a cybersecurity playbook for healthcare providers and said it will publish a "significant update" to its 2014 premarket guidance.

By Susan Kelly • Oct. 2, 2018

Stryker settles foreign corrupt practice charges, makes small acquisition

The company will pay $7.8 million to settle with the Justice Department. Separately, the medical device maker said it would acquire HyperBranch Medical Technology.

By Susan Kelly • Oct. 2, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

5 themes from The MedTech Conference

Mergers and acquisitions, digital health, FDA pilot programs and Netflix's The Bleeding Edge were among the hot topics in Philadelphia.

By David Lim , Kim Dixon • Oct. 1, 2018

FDA exploring potential for IMDRF Medical Device Single Review Program

The idea is for the marketing authorization for a medical device by one country to be relied on in part or in whole by other participating jurisdictions, according to FDA device chief Jeff Shuren.

By David Lim • Oct. 1, 2018

Ready or not, medtech braces for new EU landscape

Companies should not assume they'll get extra time to adapt, warned Vicki Anastasi, VP for medical device and diagnostics research at ICON.

By Kim Dixon • Oct. 1, 2018

AngioDynamics posts bigger net loss, looks to oncology

Executives said the company's two recent acquisitions signal a shift in investment to the oncology section of the business.

By Tyler Woods • Oct. 1, 2018

FDA finds fault with some insulin pen use directions

The agency is asking manufacturers to review their directions for use and training materials and consider adding a label warning about the need to remove both the outer and inner needle covers.

By Susan Kelly • Oct. 1, 2018

Doctor survey finds strong interest in new urology devices

Jefferies analysts polled 50 high-volume urologists and reported Teleflex's UroLift device accounted for 15% of procedures for an enlarged prostate while Boston Scientific's Rezum was used in 10%.

By Susan Kelly • Oct. 1, 2018

Hologic acquires developer of breast cancer surgery marker

The company agreed to pay $125 million for Focal Therapeutics, the latest addition to its breast health product portfolio, two months after purchasing digital imaging systems maker Faxitron Bioptics in an $85 million deal.

By Susan Kelly • Sept. 28, 2018

Butterfly raises $250M in bid to upend ultrasound market

The goal is to replace large, cart-based ultrasound devices that cost tens of thousands of dollars and upend a sector dominated by the likes of GE Healthcare, Philips and Fujifilm.

By Nick Paul Taylor • Sept. 28, 2018

New IMDRF committee to tackle cybersecurity threats

The FDA device chief laid out takeaways from the group's Beijing meeting.

By Kim Dixon • Sept. 27, 2018

FDA reopens comments on decade-old stent guidance

It comes days after physicians writing in The Lancet used data from a head-to-head comparison of Medtronic's Resolute Onyx and Biotronik's ultra-thin-strut stent Orsiro to highlight the limitations of noninferiority clinical trial designs.

By Nick Paul Taylor • Sept. 27, 2018

FDA reclassifies female condoms to reduce regulatory burden

The products will be categorized as Class II devices eligible for the 510(k) pathway.

By Nick Paul Taylor • Sept. 27, 2018

FDA expands use of Baxter bone graft to spinal fusion

Rivals Medtronic, Johnson & Johnson, Stryker and Zimmer are all competing for the bone graft substitute piece of the advanced surgery market. 

By Nick Paul Taylor • Sept. 27, 2018

Medtronic launches Infinity spine fusion system

The company's product launch comes on the heels of its $1.64 billion acquisition of Mazor Robotics.

By Susan Kelly • Sept. 26, 2018

Global device industry set to grow 5.6% a year through 2024: report

In vitro diagnostics is projected to remain as the No. 1 specialty in 2024 with annual sales of $79.6 billion and a 13.4% share of the medical device industry.

By Susan Kelly • Sept. 26, 2018

FDA's Patel touts promise of software precertification program

Despite concern from the Clinical Decision Support Coalition​ that FDA may not have the legal ability to launch the pilot, the agency says it will work through its current authorities.

By David Lim • Sept. 26, 2018

Venus to buy Keystone, moving into Boston Sci's TAVR turf

The move furthers Venus' aspirations to grow into a global transcatheter heart valve company and, by extension, advance China's bid to supercede the U.S. as the dominant medtech force.

By Nick Paul Taylor • Sept. 26, 2018

Industry lobbying CMS for speedy Medicare coverage of breakthrough devices

The Center for Medicare and Medicaid Innovation may launch a demonstration project to examine how to balance speeding devices to Medicare patients with the cost implications.

By David Lim • Sept. 25, 2018

Medtech companies race to adapt amid vertical integration, new tech threats

The industry is increasingly sharing the risk with payers as a way to prove product value.

By Kim Dixon • Sept. 25, 2018

AdvaMed chief: Success in warding off tariffs, but impact rising

While medical devices aren't explicitly on the most recent list of tariffs, the list likely includes component parts used by members of the industry.

By Kim Dixon • Sept. 25, 2018

Medtronic CoreValve proves durable in longer-term data

Severe hemodynamic structural valve deterioration was 0.8% for CoreValve versus 1.8% for surgery across five years, with similar rates of mortality and major stroke in both patient samples.

By Susan Kelly • Sept. 25, 2018

FDA gives final guidance on device benefits, risks in 510(k) submissions

The recommendations will help in determining substantial equivalence for devices with different characteristics that don't raise new questions of safety and effectiveness, the FDA said.

By Susan Kelly • Sept. 25, 2018

FDA approves Cook PAD stent as competition heats up

The approval comes shortly after Boston Scientific received clearance to sell a rival device.

By Nick Paul Taylor • Sept. 25, 2018

EY warns stagnant R&D, data use threatens medtech growth

Medtech R&D investment of $15.9 billion remained "relatively unchanged" in 2017 — roughly $1 billion less than the $16.4 billion companies gave back to investors through share buybacks and dividends.

By David Lim • Sept. 24, 2018