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

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

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

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

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

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

Canceled surgeries drive hospitals to estimate $200B in losses in early months of coronavirus

The American Hospital Association's approximation counts the first four months of the pandemic, including a forecast through June. It comes as the lobby pushes for more aid on top of the $175 billion Congress has allocated so far.

By Ron Shinkman • May 6, 2020

Notified bodies saw CE marks spike in 2019 ahead of now-delayed MDR

Team-NB attributed the surge to an industry push to get certified under the outgoing Medical Device Directive, before the COVID-19 pandemic led the EU to postpone the new regulations start date by a year.

By Nick Paul Taylor • May 6, 2020

Deferred elective procedures wipe out Smith & Nephew revenues, prompting $200M in cost cuts

The medtech's sales were nearly halved in April due to the pandemic, with its orthopaedics, sports medicine and wound management lines all experiencing drops in demand. The company is “not reducing headcount at this stage."

By Nick Paul Taylor • May 6, 2020