Medical Devices

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

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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 to propose 1-year MDR delay

A European Commission spokesperson said Wednesday a proposal could come in early April to postpone the regulation's fast-approaching go-live date, to allow greater focus on "urgent priorities related to the coronavirus crisis."

By Maria Rachal • UPDATED: March 25, 2020 at 1:11 p.m.

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: Abbott announced late Friday the FDA greenlighted its test that can detect the novel coronavirus in as little as five minutes. It runs on what the company says is the nation's most widely available molecular point-of-care testing platform.

By Nami Sumida • UPDATED: March 27, 2020 at 9:55 a.m.

CDRH lays out filing extensions, shift from in-person amid coronavirus response

Recent changes include automatically extending response due dates by 60 days for certain marketing applications, per a letter to industry Monday from device center official William Maisel.

By Maria Rachal • March 24, 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 at 11:24 a.m.

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.

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 at 5 p.m.

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

MedTech Europe sounds alarm over 'inconsistent' enforcement amid flurry of MDR updates

A lack of harmonized standards worries the trade association. Meanwhile, the Medical Device Coordination Group issued new documents on software requirements, implant cards and unique device identifiers.

By Nick Paul Taylor • March 18, 2020

Intuitive Surgical among 1st big medtechs to warn of costly pandemic disruptions

Delayed placements and procedures in China and Italy may not have a material impact on the robotic surgery giant, but similar trends in the U.S. and Europe, along with reduced capital spending by hospitals, present a greater threat.

By Maria Rachal • March 17, 2020

Endologix secures FDA approval for new abdominal stent graft

With the launch of its Alto graft device platform, the company hopes to rebuild after a series of setbacks with earlier versions of its abdominal aortic aneurysm, or AAA, repair technology.

By Susan Kelly • March 17, 2020

As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

The Medical Device Coordination Group acknowledged implementation “has proven to be a very challenging task” but for now appears to be pushing ahead with the planned May start date.

By Nick Paul Taylor • March 17, 2020