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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.

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.

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.

Hologic, LabCorp win emergency use nods as FDA eases rules to boost US coronavirus test volume

In some cases, manufacturers can distribute, and labs can use, new commercially developed tests prior to an emergency use authorization.​ FDA's updated policy also boosts states' authority to greenlight tests.

Virtual, augmented reality in medicine pique FDA's interest

The agency is hosting a workshop Wednesday with representatives from Microsoft, Facebook, Philips and other industry players in hopes of identifying roadblocks to developing more uses of extended reality for medical purposes.

Disease management firms set to capitalize on Trump admin interoperability push

A key detail of a rule finalized last week could make it simpler for Omada Health, Propeller Health and Livongo to interface with large health system clients.

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.

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.

Hospitals advised to rethink elective procedures, potentially straining device makers

The Surgeon General and American College of Surgeons urged hospitals to "minimize, postpone, or cancel" certain procedures while handling the COVID-19 outbreak, presenting at least a temporary risk to medtechs' revenue.

Value-based payment models take hold in medtech, but barriers slow shift

The arrangements are becoming more prevalent, especially for costly devices used in chronic disease management and in hospital settings, according to a recent Deloitte report.

To fight coronavirus spread, high-throughput tests bring potential benefits, challenges

Deborah Birx, White House coronavirus response coordinator, said labs will just as importantly need supplies to ramp up testing. The American Clinical Laboratory Association is concerned about potential supply shortages.​    

Thermo Fisher coronavirus test gets FDA nod

Trump administration officials promised on Sunday that 2,000 labs would be running 1.9 million tests this week. Separately, the American Clinical Laboratory Association expects daily testing capacity to exceed 20,000 next week, with the potential to grow to 280,000 by April 1.  

Roche is 1st commercial coronavirus test maker to win FDA emergency use authorization

After FDA allowed the company to pre-position its test in the U.S., Roche said it's committed to "going to the limits" of its production capacity to churn out millions of tests per month.

Trump declares national emergency, opening up billions for coronavirus

The president also teased an imminent FDA emergency use authorization for a test from Thermo Fisher, with LabCorp and Quest saying they're collaborating with Roche.

UPDATED: March 13, 2020 at 5:22 p.m.

CDC chief: Reagents critical to coronavirus tests​ 'now are in short supply'

Separately, the government Friday announced funding for development of COVID-19 diagnostic tests from DiaSorin Molecular and Qiagen meant to detect the pathogen in about an hour. 

Natera breaks ties with Qiagen on NGS testing, citing Illumina deal

The companies teamed up two years ago to develop cell-free DNA assays for a Qiagen reader system, but Thermo Fisher-bound Qiagen later shifted course, which Natera said was a "material breach of the agreement."

Senseonics cites Freestyle Libre pricing as factor in its Roche deal challenges

The implantable continuous glucose monitor maker forecast sales outside the U.S. to drop by one-third this year.  

FDA chief warns of supply 'pressure' on reagents for coronavirus tests

Qiagen, a major supplier of RNA extraction kits, confirmed to MedTech Dive Thursday that "extraordinary demand for coronavirus testing workflows" is challenging the company's capacity.

FDA finalizes contentious guidance on third party 510(k) reviews

Meant to enable faster decisions and free up the agency to focus on higher risk devices, earlier versions took fire from AdvaMed and some patient groups.

TransMedics to get FDA expert review for heart transplant device PMA

The agency's Circulatory System Devices Panel is set to vote April 16 on recommendations regarding the organ preservation medtech's system for donor hearts.

As US officials shift tone on coronavirus, Trump stops short of 1 provider ask

The president did not declare a disaster or national emergency, which groups like the American Hospital Association had sought.

Key EU notified body meeting goes on, virtually

A Medical Device Coordination Group meeting, parts of which are postponed, comes as Germany, home to four of 11 notified bodies designated under EU MDR, anticipates widespread COVID-19 transmission.

FDA issues Class I recall for Medtronic's HeartWare HVAD after patient death

A design flaw flagged by Medtronic in January regarding its ventricular assist devices landed a high-risk label from regulators this week.

Rival to Boston Scientific device used in TAVR wins CE mark

Keystone Heart, the Israel-based unit of Chinese structural heart player Venus Medtech, is readying an FDA submission for its cerebral embolic protection device, intended to reduce stroke risk during transcatheter heart procedures.

White House, CDC under fire for availability of coronavirus tests

The Trump administration is facing criticism that federal agencies did not engage the big private labs early enough in the public health emergency.