Inari Medical launches IPO, shares take off

The maker of mechanical thrombectomy devices sees a $3.6 billion annual U.S. market opportunity. It had the best first-day performance of 74 initial public offerings launched so far this year, Bloomberg calculated.

By Susan Kelly • May 26, 2020

ResMed, Medtronic embrace remote tech amid COVID-19, say it’s here to stay

The crisis has sped adoption of digital health technologies to help hospitals create safe physical distances between healthcare workers and patients. Execs say some could become permanent products.

By Greg Slabodkin • May 26, 2020

Explore the Trendline➔

Top 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

Martha plots M&A, Hugo robot sees delay: Takeaways from Medtronic’s Q4

Despite the negative impacts of COVID-19 on revenue in the latest quarter, the medtech giant has its strongest balance sheet in years and is looking for acquisition opportunities in the pandemic landscape.

By Maria Rachal , Greg Slabodkin • May 22, 2020

FDA eases rules on changes to PMA, HDE devices to avoid coronavirus supply disruptions

Companies that market medical devices under premarket approvals or humanitarian device exemptions can make limited modifications to design and production without giving prior notice, according to special guidance.

By Nick Paul Taylor • May 22, 2020

April was dismal for US hospitals, with long road ahead, surveys find

Operating margins plummeted 174% last month compared to April 2019 and were down 118% from March of this year as surgeries, ER visits and outpatient appointments declined drastically during the COVID-19 pandemic.

By Shannon Muchmore • May 21, 2020

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

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

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