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

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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

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

Oncology systems maker Varian ekes out sales gain amid procedure delays

The company managed a 2% uptick in Q2 revenues despite the slowdown in non-essential procedures as people postponed routine screenings, which in turn has delayed the start of treatment for new cancer patients.

By Susan Kelly • May 5, 2020

AHA, societies share new roadmap amid restarts to TAVR, other postponed procedures

As more U.S. states ease coronavirus-driven restrictions on elective medical care, North American cardiovascular groups laid out stages of safe reintroduction for invasive procedures and diagnostic imaging.

By Nick Paul Taylor • May 5, 2020

Respiratory muscle stimulator greenlighted by FDA for COVID-19 patients

In an attempt to more quickly free up sought-after ventilators and limit long-term health risks, the Liberate Medical device aims to provide therapy that reduces disuse atrophy of the abdominal wall muscles.

By Maria Rachal • May 4, 2020

7 states team up to buy $5B in ventilators, PPE to meet COVID-19 demand

New York, New Jersey, Connecticut, Pennsylvania, Delaware, Rhode Island and Massachusetts are aiming to use their combined purchasing power to drive down prices amid rivalry with other states and even the federal government.

By Rebecca Pifer • May 4, 2020

Ventilator sharing among states critical to save COVID-19 patient lives: Health Affairs paper

Without a coordinated federal effort to promote the exchange of the breathing assist machines, thousands more Americans will die in the coming weeks as the virus continues its rampage across the U.S., a new paper warns.

By Susan Kelly • May 4, 2020

Stryker sees 50% of revenue vulnerable to elective procedure pullback

Despite making it out of Q1 with total sales up 2%, the medtech's U.S. orthopaedics and spine sales dropped roughly 65% in April after a near total halt in non-essential procedures due to the coronavirus pandemic.

By Maria Rachal • May 1, 2020

Coronavirus surge in critical care sales helps Hillrom beat Q2 guidance

The company on Friday said it is hiring 300 additional staff globally to enable a fivefold increase in production of non-invasive ventilators, while doubling output of other products in high demand for COVID-19 patients. 

By Nick Paul Taylor • May 1, 2020

COVID-19 spurs 'incredible demand' for ventilators, buoying ResMed's 16% revenue uptick

CEO Mick Farrell told investors sales of breathing assist machines added $35 million in coronavirus-related revenue. However, sleep testing declined by double digits.

By Greg Slabodkin • May 1, 2020

Medtronic continuous dialysis system designed for small children gets FDA nod

The De Novo authorization, one of a only a handful doled out by the agency so far this year, gives Medtronic a chance to dominate a pediatric niche. Baxter tested a similar system but terminated the study in 2018.

By Nick Paul Taylor • May 1, 2020

Abiomed buys artificial lung device for use with Impella, potential COVID-19 patients

The addition of a novel ECMO system comes as management attributed declines in recent heart pump sales to lingering negative sentiment following a pair of studies released last year and the pandemic's impact on procedures.

By Maria Rachal • April 30, 2020