Medical Devices: Page 124
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Novocure shares data from post-approval brain cancer device trial
As part of the virtual AACR 2020, researchers said data show use of a Novocure technology resulted in longer median overall survival than occurred with best standard of care chemotherapy.
By Nick Paul Taylor • April 28, 2020 -
FDA tweaks electronic filing guidance amid heavy use of emergency authorization pathway
After taking paper out of the medical device premarket application process in December, the agency's updated guidance features a new option for companies seeking emergency use authorization, common during the pandemic.
By Nick Paul Taylor • April 28, 2020 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Alex Wong via Getty Images
CMS hits pause on speeding Medicare payments, including for DME suppliers
The Trump administration is suspending accelerated Medicare pay to doctors and durable medical equipment suppliers, and is re-evaluating hospital requests, after another round of emergency funding was signed into law Friday.
By Rebecca Pifer • April 27, 2020 -
Edwards sees 14% sales bump in Q1, but near-term TAVR prospects grim
Results beat Wall Street's expectations on momentum in the transcatheter aortic valve business at the start of the first quarter. But CEO Mike Mussallem warned that since then: "We've watched the system really screech to a halt."
By Susan Kelly • April 24, 2020 -
It's official: EU finalizes 1-year MDR delay
The European Commission listed a 13th notified body designated for Medical Device Regulation-related work in its official database Saturday, the first new firm announced in over a month and the fifth based in Germany.
By Maria Rachal • Updated April 27, 2020 -
FDA moves to boost access to imaging systems during pandemic
The agency is allowing devices to be modified for portable use to enable imaging outside of hospitals in an effort to potentially slow the spread of COVID-19.
By Nick Paul Taylor • April 24, 2020 -
FDA grants breakthrough status to heart failure, stent graft tech
The newly disclosed breakthrough device designations follow ones awarded to a speech therapy app and a treatment for stable vertebral compression fractures in recent weeks.
By Nick Paul Taylor • April 24, 2020 -
Senseonics averts cash crunch with $20M loan but future remains grim
The much-needed funds buy the company some time to look for a potential acquirer and secure FDA approval of a 180-day version of its implantable continuous glucose monitor.
By Nick Paul Taylor • April 23, 2020 -
MedTech Europe pushes for IVDR delay as MDR hold nears finish line
The trade group warned that "even before the COVID-19 pandemic, very little progress had been achieved" to get the In Vitro Diagnostic Regulation ready, which it said altogether warrants at least a 12-month delay.
By Nick Paul Taylor • April 23, 2020 -
Medtronic sees US business fall 60% amid pandemic response
The subset of devices suddenly seeing higher demand are mostly low-margin businesses, leading the medtech giant to brace investors for a hit to earnings during next month's quarterly report.
By Maria Rachal • April 22, 2020 -
ResMed to get biggest bang out of HHS ventilator contracts, analysts predict
Medtronic and Hillrom may see limited gains from their smaller deals, but ResMed’s contract could add a 2.7% bump to growth in the fourth quarter, Needham analysts noted.
By Nick Paul Taylor • April 21, 2020 -
CMS, surgeons group offer paths forward to resume elective procedures
Johnson & Johnson, Abbott and Intuitive Surgical are among the device makers that reported the widespread deprioritization of surgeries during the pandemic dented sales at the end of the first quarter.
By Susan Kelly • April 20, 2020 -
Philips to invest $109M as COVID-19 drives connected care order growth
CEO Frans van Houten said sourcing component parts from affected suppliers has been a challenge amid increasing demand for ventilators, patient monitors and certain diagnostic devices.
By Nick Paul Taylor • April 20, 2020 -
FDA device review times could get iffy, agency chief says
"It is difficult to speculate on what the exact impact will be on incoming submissions moving forward," Commissioner Stephen Hahn said in an update on hitting MDUFA goals amid the constraints of the public health emergency.
By Maria Rachal • April 17, 2020 -
EU MDR delay clears Parliament, enters final stages
During a plenary focused on combating the coronavirus pandemic, the European Parliament on Friday voted overwhelmingly in favor of pushing back the regulatory overhaul. A few steps remain.
By Nick Paul Taylor • April 17, 2020 -
GE, Ford get $336M HHS contract for 50K lower-cost ventilators
The latest deal works out to about $6,720 per ventilator. GE's roughly $64 million contract for 2,410 ventilators detailed earlier this week works out to a little more than $26,000 per device.
By Nick Paul Taylor • April 17, 2020 -
Pandemic drives US da Vinci robot use down 65%
A major shift to leasing the robotic surgery systems and other alternative financing arrangements is on the horizon, Intuitive predicts, amid early signs cash-strapped hospitals are deferring big purchases in the wake of COVID-19.
By Nick Paul Taylor • April 17, 2020 -
Courtesy of Abbott, PRNewswire
Abbott pulls 2020 guidance but expects coronavirus testing gains to show in Q2
"We haven't seen a quarter or any time quite like this before," new CEO Robert Ford told investors on an earnings call, during which he also addressed comments by some Trump administration officials on testing capacity.
By Greg Slabodkin • April 16, 2020 -
Courtesy of University of Minnesota
Boston Scientific to begin selling cheaper ventilator alternative
The "cereal box"-sized device OK'd by FDA will sell for a fraction of the price Philips is charging the U.S. government for its ventilators.
By Nick Paul Taylor • April 16, 2020 -
Device to wean COVID-19 patients off ventilators gains EUA
FDA said the Synapse Biomedical diaphragm stimulator could cut the time easing patients off the breathing support devices from four days to 2.6, with less time on a ventilator also cutting risk of secondary pneumonia.
By Susan Kelly • April 15, 2020 -
Philips launches scaled-down ventilator, inks production deals to boost output
The medtech has allied with smaller players Flex and Jabil with a goal of 4,000 units per week by the third quarter and is also rolling out an alternative to its full-featured critical care breathing devices amid the coronavirus pandemic.
By Nick Paul Taylor • April 15, 2020 -
Alex Wong via Getty Images
GE, Medtronic, ResMed among 7 medtechs part of $1.4B in finalized HHS ventilator contracts
Building on more than $1.1 billion announced for GM and Philips last week, the latest batch of contracts are aimed at producing over 64,000 of the potentially life-saving devices for COVID-19 patients.
By Maria Rachal • April 14, 2020 -
CMS removes ventilators from DME bidding program due to high coronavirus demand
Needham analysts said companies including ResMed, Hillrom and Inogen may benefit from the policy shift, given non-invasive ventilators could have faced reimbursement cuts as steep as 50% or more.
By Susan Kelly • April 14, 2020 -
J&J blames pandemic for medical device sales slump
CEO Alex Gorsky told investors Tuesday the company expects COVID-19 headwinds to continue "while elective procedures are deferred and hospital resources are redeployed to address patients impacted by this pandemic."
By Nick Paul Taylor • April 14, 2020 -
The latest coronavirus shortage: hospital infusion pumps
A surge in COVID-19 cases is not only straining the supply of the devices that administer medications and fluids, but the potentially risky tubing that allows them to be situated in hallways to create distance from sick patients' rooms.
By Greg Slabodkin • April 14, 2020
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