High-risk devices with expedited reviews more likely to be recalled, research suggests

As FDA's Breakthrough Devices Program rises in popularity, a JAMA Internal Medicine analysis found almost two-thirds of Class III devices approved with priority review status between 2005 and 2015 were recalled.

By Nick Paul Taylor • March 31, 2020

AdvaMed wary of Trump's use of DPA to boost ventilator production

The medtech industry contends the Defense Production Act could strain the supply chain, but the administration says it's "working to sign contracts immediately" with GE, Medtronic, ResMed and other major manufacturers.

By Greg Slabodkin • March 30, 2020

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

Low-risk TAVR: Edwards results taper in 2nd year, Medtronic targets bicuspid market

The companies again looked to expand use of the procedure a year after presenting pivotal data at the American College of Cardiology meeting on the low-risk population, but results were less emphatic.

By Nick Paul Taylor • March 30, 2020

Medtronic's renal denervation system shows it can lower blood pressure

Results presented at the American College of Cardiology's virtual meeting come after a big setback in 2014 when the device failed to show effectiveness. 

By Susan Kelly • March 30, 2020

FDA outlines role for 3D printing in coronavirus response, with some caution

Additive manufacturing has emerged as a tool to help bolster availability of critical devices like ventilators and testing supplies, but the agency said 3D-printed personal protective equipment may not be as effective.

By Nick Paul Taylor • March 27, 2020

A better way to manage medical device inventory

By bringing the latest technology into the warehouse and out in the field, manufacturers and suppliers can reduce operational costs and stay competitive in a value-based environment.

March 27, 2020

FDA OKs anesthesia gas machines as ventilators amid coronavirus shortage fears

GE Healthcare, which has more than 100,000 of its anesthesia devices worldwide, noted differences but acknowledged the "need to weigh the relative risks and benefits to support patients in these unprecedented times."

By Greg Slabodkin • March 26, 2020

Medtech industry asks for FEMA's help allocating ventilators to frontlines

AdvaMed said a lead federal agency should be designated to manage distribution of the breathing machines as manufacturers rapidly scale up production in response to the COVID-19 crisis.

By Susan Kelly • March 25, 2020

How health systems are responding as COVID-19 squeezes the medical supply chain

Procurement of supplies will become more difficult if cases surge and federal stockpiles don't trickle down to the state level quickly enough.

By Deborah Abrams Kaplan • March 25, 2020

EU regulators propose 1-year MDR delay

The European Commission formally proposed Friday the Medical Device Regulation start date be moved to May 26, 2021. It needs the quick backing of the European Parliament and Council.

By Maria Rachal • Updated April 3, 2020

FDA still trying to fine-tune Pre-Cert as pilot enters 2020

The Pre-Cert​ pilot, which includes Apple, J&J and Fitbit, is moving forward with the agency "working through the nine companies, trying to figure out how they actually do business," FDA's Bakul Patel told MedTech Dive.

By Greg Slabodkin • March 25, 2020

5 facts about the nation's stockpile of emergency medical supplies

As healthcare workers across the country scramble for personal protective equipment and other supplies, states are sending in their requests to the Strategic National Stockpile.

By Hailey Mensik • March 24, 2020

Tracking the impact of coronavirus on the medtech industry

Among the latest: As COVID-19 test sales boom, Hologic thinks its revenues this quarter may be 60% higher than last year's.

By Nami Sumida • Updated Sept. 11, 2020

CDRH pushes out response due date extensions, teleconference policy by at least a month

Less than two weeks after FDA wrote to industry extending deadlines for premarket application responses and warning of disruptions to in-person meetings, the agency lengthened those coronavirus-era changes.

By Maria Rachal • Updated April 6, 2020

MedTech Europe calls for delay of MDR until coronavirus crisis passes

The trade group argued industry is “working relentlessly” on getting devices to healthcare professionals fighting COVID-19, while simultaneously trying to maintain supply of other products, leaving little bandwidth to focus on new regs.

By Nick Paul Taylor • March 24, 2020

Senseonics halts new CGM sales, pulls 2020 guidance

Days after the diabetes medtech said it's exploring "strategic alternatives," analysts at Stifel predict the company's latest moves will give it $15 million in cash at the end of Q1, enough to survive for another quarter "or so."

By Susan Kelly • Updated March 26, 2020

FDA eases rules on ventilator makers as Medtronic and Tesla talk

Hardware and software modifications can occur without submission of a 510(k) as traditional medtechs team with other manufacturers to meet coronavirus-driven demand for the devices.

By Nick Paul Taylor • March 23, 2020

FDA greenlights expanded remote patient monitoring to keep patients out of coronavirus-slammed hospitals

The agency said it wants to help healthcare providers diagnose and treat patients who remain at home in the midst of the national emergency.

By Susan Kelly • March 20, 2020

Diagnostic, device makers scrambling as COVID-19 sweeps US

What began as a potential Q1 headwind for medtechs manufacturing in China has quickly turned into a global crisis with unprecedented challenges and opportunities as the sector grapples with the pandemic.

March 20, 2020

Medtronic pledges '24/7' ventilator production to meet coronavirus demand

The company is aiming to more than double its manufacturing capacity as GE, Getinge, Philips and others outside of healthcare commit to boosting worldwide supply of the potentially lifesaving machines.

By Maria Rachal • March 19, 2020

CMS urges hospitals to put off elective procedures

The guidelines suggest three tiers, with procedures like hip and knee replacements falling into the "consider postponing" category.

By Shannon Muchmore • March 19, 2020

New notified bodies trickle in ahead of looming MDR start date

The 12th notified body authorized for MDR work, and the first from Hungary, was listed in the NANDO database Friday: CE Certiso.

By Nick Paul Taylor • Updated March 20, 2020

FDA pulls plug on routine US inspections

The move to protect staff and acknowledge industry worries about outside visitors amid coronavirus comes a week after the agency said it would postpone nearly all overseas inspections through April.

By Nick Paul Taylor • March 19, 2020

Lessons from Hurricane Maria could aid Baxter's coronavirus operations

The aftermath of the 2017 storm led to serious manufacturing disruptions to Baxter's IV business and prompted it to strengthen its supply network, which CEO Joe Almeida said might be abating challenges with COVID-19 so far.

By Maria Rachal • March 18, 2020

Moody's cuts medtech outlook on coronavirus upheaval

The pandemic is likely to stall significant M&A activity in the sector, the ratings agency predicts.

By Susan Kelly • March 18, 2020