Medical Devices: Page 122
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Medtronic's revenue dropped 26% in Q4 as coronavirus hit broadly
New CEO Geoff Martha told investors Thursday nearly all sides of the business were negatively impacted by the pandemic's effects.
By Greg Slabodkin • May 21, 2020 -
Hospitals push FEMA to form broad supply pact with medtech
The agency on Thursday is set to discuss a proposed five-year voluntary agreement with industry to better distribute medical products, which health systems hope will go beyond personal protective equipment.
By Nick Paul Taylor • Updated May 26, 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 -
AdvaMed, health systems set ground rules for return of sales reps
Hospitals, nurses and the medtech industry issued guidance to pave the way for device company representatives to re-enter healthcare facilities.
By Susan Kelly • May 20, 2020 -
COVID-19 drives EC to change rules on notified body designations
The European Commission is allowing certain deviations from normal procedures governing notified bodies, enabling renewal of designations under the outgoing device regulations without performing on-site assessments.
By Nick Paul Taylor • May 20, 2020 -
Investors bet diabetes tech immune to full brunt of COVID-19
Pure play diabetes device makers aren't clear yet on how economic uncertainty and the transition to telemedicine may affect new patient demand, but are outperforming the stock market by a long shot.
By Maria Rachal • May 19, 2020 -
Edwards secures CE mark for Pascal tricuspid valve repair device
European approval for the device comes about a month after rival Abbott gained a CE mark for a tricuspid version of MitraClip. Edwards sees tricuspid and mitral valve treatments as a $3 billion market opportunity by 2024.
By Susan Kelly • May 19, 2020 -
Knee replacements nearly halted as hospitals braced for COVID-19, new data show
Even service lines covering often life-threatening conditions saw large drops, with cardiac care falling 57% and cancer care down 37% versus March and April last year, according to analysis by Strata Decision Technology.
By Shannon Muchmore • May 19, 2020 -
Medtronic offers 10-year data, pivotal trial update on transcatheter pulmonary valves
A decade of data on the Melody valve found it more effective in adults than in pediatric patients. In a separate study, the in-development Harmony valve designed to treat severe pulmonary regurgitation met its primary endpoints.
By Susan Kelly • May 18, 2020 -
Allergan's breast implant postmarket studies 'unacceptable,' FDA warns
Within the last 14 months, every manufacturer of the controversial devices allowed for sale in the U.S. has received a warning letter from the agency.
By Maria Rachal • May 15, 2020 -
FDA revokes umbrella EUA for infusion pumps due to lack of industry use
The agency told medtechs it may instead grant individual EUAs for the devices going forward. B. Braun contends it is the only company with such an emergency authorization and is not affected by the revocation.
By Greg Slabodkin • Updated Sept. 24, 2020 -
Cardiology group ranks best devices for aorto-iliac arterial interventions
The Society for Cardiovascular Angiography and Interventions detailed stances on several key issues, including endovascular device effectiveness, issued Thursday at its virtual conference.
By Nick Paul Taylor • May 15, 2020 -
Consumer COVID-19 fears, coverage concerns could stymie medtech rebound: Wall Street surveys
Some analysts say industry predictions on timing of a rebound in elective procedures may be too rosy.
By Maria Rachal • May 14, 2020 -
Courtesy of Caption Health, PRNewswire
Philips, startups look to deploy new ultrasound tech amid coronavirus
The need for point-of-care imaging for lung and cardiac complications among COVID-19 patients has led to a flurry of expedited FDA reviews.
By Nick Paul Taylor • May 14, 2020 -
EC outlines clinical trial safety reporting between MDR, Eudamed start dates
Even with the recent delay to the date of application of the Medical Device Regulation, there will still be at least a 12-month period when the key Eudamed database is not fully available.
By Nick Paul Taylor • May 14, 2020 -
House Dems carve out $75B for coronavirus testing, contact tracing in bid for new relief package
The $3 trillion bill passed the House by a vote of 208-199 on Friday. It's Democrats' opening gambit for the next wave of congressional action, but Republicans say they're not in a hurry to approve new funding.
By Susan Kelly • Updated May 18, 2020 -
FDA flags 2nd high-risk recall of embolectomy catheters in recent weeks
The potential for a detached catheter tip to damage blood vessels and cause serious injuries or death underpinned the agency’s Class I label for an Applied Medical recall on Tuesday, seven months after the company initiated the recall.
By Nick Paul Taylor • May 13, 2020 -
Abiomed faces familiar reimbursement fluctuation in CMS proposal
An almost 25% reduction to a key heart implant procedure payment code, plus backing for three breakthrough-designated devices, are among the policies outlined in a Medicare proposed rule released Monday afternoon.
By Maria Rachal • May 12, 2020 -
Wright Medical sales miss consensus as lower extremities business drags
Additionally, the device maker set to be acquired by Stryker has amended a credit agreement with lenders, which some analysts expect to dampen any concern that the buyer could look to renegotiate the deal.
By Susan Kelly • May 12, 2020 -
FDA, CDC drawing up plan to restart routine facility inspections
A phased approach is in the works to reintroduce certain oversight that's been on hold both domestically and internationally since the coronavirus outbreak reached pandemic level in March.
By Nick Paul Taylor • May 12, 2020 -
Q&A
Are CFOs ready to go with the EU Medical Device Regulation?
Requiring fewer applications to submit for approval, the new process could ultimately cost companies less, according to a CFO Dive interview with the director of market access for life sciences at BDO USA.
By Ed McCarthy • May 12, 2020 -
Zimmer posts $509M loss in Q1 as 80% of business faces COVID-19 hit
Like rivals, the medtech expects Q2 to bear the brunt of deferred procedures. But the pace of expected recovery thereafter is fluid and does not assume significant recurrence of the virus later this year, execs noted.
By Maria Rachal • May 11, 2020 -
AtriCure treatment for persistent AFib shows superiority in study
The ablation procedure met study goals among patients with hard-to-treat forms of the heart rhythm disorder, which analysts say put it on track for FDA approval to address a market worth at least $1 billion.
By Susan Kelly • May 11, 2020 -
Courtesy of Centers for Disease Control and Prevention
Roundup: Q1 medtech reports give glimpse into coronavirus-era gains and losses
Much of the sector may be considered recession-proof — but it's not social distancing-proof. The last weeks of March previewed the dramatic trajectory of drops in routine testing and a mounting backlog of elective procedures.
By Maria Rachal • May 7, 2020 -
BD says surgery revenues fell as much as 70% in April
As it faces pandemic headwinds, BD is also continuing to deal with problems with its Alaris infusion pump system and modules and expects to record a $200 million charge related to remediation efforts.
By Greg Slabodkin • May 7, 2020 -
FDA details COVID-19 era reporting rules to stymie medical device shortages
Under new powers granted by the CARES Act for the duration of the health crisis, the guidance to industry lays out when and how to notify the agency about changes that could affect product availability.
By Nick Paul Taylor • May 7, 2020
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