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

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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

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

Hologic to launch 2nd coronavirus test amid broader sales slide

The molecular diagnostics business posted its best growth rate in eight years, but the breast health and surgical segments slowed as a result of postponed elective surgeries.

By Susan Kelly • April 30, 2020

Teleflex yanks guidance as coronavirus craters key product

Sales of UroLift plummeted 64% in the last two weeks of March, wiping out an important growth driver.

By Nick Paul Taylor • April 30, 2020

Baxter cites 'extraordinary' Q1 demand from customers fighting coronavirus

Revenues grew 6% to $2.8 billion thanks to growth across all six of the company's global business units and three geographic segments.

By Greg Slabodkin • April 30, 2020

AdvaMed pushes US to lift tariffs on Chinese imports of COVID-19 devices

The trade group wants indefinite exemptions for imaging components and devices used in ventilators, among other items. It also floated a compromise: re-imposing them one year after the pandemic passes.

By Nick Paul Taylor • April 30, 2020

Boston Scientific sees April sales cut in half amid coronavirus

One potential area of optimism: two-thirds of the device giant's business comes from procedures in outpatient settings like ambulatory surgery centers and physicians offices, which the company expects will resume operations sooner.

By Maria Rachal • April 29, 2020

Dexcom's hospital strategy accelerates, but next-gen iCGM path slows

The continuous glucose monitor manufacturer recorded its highest number of new users ever during the first quarter as it topped Wall Street revenue estimates by around $50 million, weathering a dip in business in late March.

By Maria Rachal • April 29, 2020

GE reducing healthcare headcount in $700M cost-cutting drive

The cuts come as the conglomerate seeks to adapt its business to volatility and pressures created by the global coronavirus pandemic.

By Nick Paul Taylor • April 29, 2020

FDA says 18 deaths linked to intragastric weight loss balloons

The liquid-filled devices manufactured by Apollo Endosurgery have generated more than 230 adverse event reports to the agency, but regulators still believe they can be an effective treatment for some patients.

By Susan Kelly • April 28, 2020

Novocure shares data from post-approval brain cancer device trial

As part of the virtual AACR 2020, researchers said data show use of a Novocure technology resulted in longer median overall survival than occurred with best standard of care chemotherapy.

By Nick Paul Taylor • April 28, 2020

FDA tweaks electronic filing guidance amid heavy use of emergency authorization pathway

After taking paper out of the medical device premarket application process in December, the agency's updated guidance features a new option for companies seeking emergency use authorization, common during the pandemic.

By Nick Paul Taylor • April 28, 2020

CMS hits pause on speeding Medicare payments, including for DME suppliers

The Trump administration is suspending accelerated Medicare pay to doctors and durable medical equipment suppliers, and is re-evaluating hospital requests, after another round of emergency funding was signed into law Friday.

By Rebecca Pifer • April 27, 2020

Edwards sees 14% sales bump in Q1, but near-term TAVR prospects grim

Results beat Wall Street's expectations on momentum in the transcatheter aortic valve business at the start of the first quarter. But CEO Mike Mussallem warned that since then: "We've watched the system really screech to a halt."

By Susan Kelly • April 24, 2020

It's official: EU finalizes 1-year MDR delay

The European Commission listed a 13th notified body designated for Medical Device Regulation-related work in its official database Saturday, the first new firm announced in over a month and the fifth based in Germany.

By Maria Rachal • Updated April 27, 2020

FDA moves to boost access to imaging systems during pandemic

The agency is allowing devices to be modified for portable use to enable imaging outside of hospitals in an effort to potentially slow the spread of COVID-19. 

By Nick Paul Taylor • April 24, 2020

FDA grants breakthrough status to heart failure, stent graft tech

The newly disclosed breakthrough device designations follow ones awarded to a speech therapy app and a treatment for stable vertebral compression fractures in recent weeks.

By Nick Paul Taylor • April 24, 2020