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

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Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

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

Harvard, INSEAD authors pitch systemic regulatory approach to AI/ML devices

A new paper in Nature's digital medicine journal argues that real-world performance of specific SaMD products using artificial intelligence will vary considerably by hospital and other factors.  

By Nick Paul Taylor • April 8, 2020

Embolism risk prompts FDA to treat Boston Scientific recall as Class I event

The agency is aware of nine injuries resulting from detached tips of angiographic catheters, used to deliver contrast agents to blood vessels.

By Nick Paul Taylor • April 8, 2020

Study questions TAVR access disparities under new CMS coverage policy

The number of hospitals offering the less invasive aortic valve disease treatment could double under Medicare's revised coverage, but limited access in rural and safety net hospitals appears likely to persist, according to research.

By Susan Kelly • April 7, 2020

FDA OKs changes to oxygenation devices to treat coronavirus patients

A surge in patients with the sudden acute respiratory syndrome led to easing of allowed uses for cardiopulmonary bypass devices and ECMO machines. Medtronic and Getinge are among makers of the impacted devices.

By Nick Paul Taylor • April 7, 2020

FDA allows for infusion pump modifications to prevent shortages

In a bid to "reduce supply chain interruptions and manufacturing bottlenecks" during the pandemic, the agency will permit some changes to the pumps and accessories without the added step of a new 510(k) submission.

By Susan Kelly • April 6, 2020

Industry cheers COVID-19 executive order to boost ventilator supply chain

While AdvaMed has pushed back on using the Defense Production Act, the move is meant to help domestic manufacturers by removing hurdles to accessing parts and materials needed to ramp up production of ventilators.

By Greg Slabodkin • April 3, 2020