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

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

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

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

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

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

FDA EUAs go to 1st blood purifiers for COVID-19 patients, new N95 sterilizers

Terumo and CytoSorbents are behind blood purification devices designed to reduce inflammatory proteins in COVID-19 patients admitted to the ICU with confirmed or imminent respiratory failure.

By Susan Kelly • April 13, 2020

Court sides with Nevro over Boston Scientific in pain device patent dispute

A judge in the U.S. Court of Appeals for the Federal Circuit found a lower court erred in invalidating four Nevro patents covering high-frequency spinal cord stimulation.

By Nick Paul Taylor • April 10, 2020

Abbott lands CE mark for tricuspid sibling of MitraClip

The milestone for its structural heart business follows a a CE mark it received for a trancatheter mitral valve replacement device, as it still awaits U.S. approval of a transcatheter aortic valve replacement device.

By Nick Paul Taylor • April 10, 2020

Medtechs adapt to new sales reality amid halt on elective surgeries, hospitals' financial stress

Device manufacturers can't control how long COVID-19 shuts down the procedures and traditional sales models they depend on. But their flexibility during the down period can make or break the restart, industry advisers say.

By Maria Rachal • April 9, 2020

EU permits remote notified body audits during pandemic

The guidance came the day after the Council of the EU responded to the European Commission's proposal for a one-year delay to the Medical Device Regulation, which Parliament is set to vote on next week.

By Nick Paul Taylor • April 9, 2020

GM, Philips land $1.1B in HHS ventilator contracts, Medtronic boosts production

Much of industry has been prodded to ramp up production of the often large, complex and pricey breathing devices barely mentioned in company financials before the pandemic but now are critical for the sickest COVID-19 patients.

By Nick Paul Taylor • April 9, 2020

Coronavirus chaos ripe for hackers to exploit medical device vulnerabilities

Interpol warned that cybercriminals are using ransomware to target healthcare organizations already overwhelmed by COVID-19, and noted a significant increase in detected health system attacks since the start of the pandemic.

By Greg Slabodkin • April 8, 2020