ResMed beats Street with ventilators driving revenue up 9%, but tailwinds ebbing

“While we are still working on current and future contracts with hospitals, as well as city and national health authorities for these ventilators, the volumes will be significantly lower in the September quarter,” said CEO Mick Farrell.

By Greg Slabodkin • Aug. 5, 2020

NuVasive’s spine robot sees delay, again

Amid COVID-19 constraints, the Pulse application may not be used in humans until 2022 in a spinal robotics market some analysts call significantly untapped.

By Maria Rachal • Aug. 5, 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

Zimmer sees COVID-19 backlog worth up to $800M, aims to double Rosa robot volume by year’s end

Like rival Stryker, new placements of the company’s robot-assisted knee replacement systems had traction during a second quarter when deferral of elective procedures took away over a third of its typical total revenue.

By Maria Rachal • Aug. 4, 2020

Medtronic, in catch-up to Axonics, wins nod for rechargeable bladder and bowel control device

After leading the sacral neuromodulation market for two decades, Medtronic is defending its turf with FDA approval of a product it contends is 80% smaller than its current device and 50% smaller than Axonics’ rechargeable system.

By Susan Kelly • Aug. 4, 2020

CMS proposes eliminating inpatient-only list, in potential boon for ASCs

The agency would begin by removing about 300 musculoskeletal-related services, which could further accelerate ambulatory surgery centers’ important role as medtech customers.

By Shannon Muchmore • Aug. 4, 2020

Device maker Q2 reports show optimism on COVID-19 recovery, but flare-ups keep guidance at bay

Since March and April lows, business volume has improved sequentially. Still, many medtechs are tightlipped on what that may mean for financial performance for the rest of the year.

By Maria Rachal • Aug. 3, 2020

House panel asks IG to investigate Trump admin bungling of Philips ventilator deal

The Subcommittee on Economic and Consumer Policy on Thursday sent a letter to the acting inspector general requesting a probe into findings that HHS overpaid by $500 million in a contract negotiated with the Dutch medtech. 

By Susan Kelly • Updated Aug. 7, 2020

Varian sold to Siemens Healthineers in $16.4B all-cash deal

Breaking with a trend of smaller medtech deal values in 2020, the pact will see radiation oncology equipment and software maker Varian Medical Systems operate as an independent company under Siemens Healthineers.

By Maria Rachal • Updated Aug. 3, 2020

Stryker sales slump 24% on elective surgery hits, but Mako robot demand a ‘pleasant surprise’

Looking to the third quarter, “we expect the recovery to continue, but do not expect it to be linear, while local governments deal with varying degrees of resurgences,” CEO Kevin Lobo said on an earnings call Thursday. 

By Maria Rachal • July 31, 2020

J&J gets FDA breakthrough status for robot-assisted ablation device

The designation gives the product, which combines technologies Johnson & Johnson acquired via takeovers of NeuWave Medical and Auris Health, more regulatory support and potentially speedier review.

By Nick Paul Taylor • July 31, 2020

Teleflex reports rapid rebound in UroLift sales, driving Q2 beat

The medical device maker also disclosed an unspecified number of job cuts and a DOJ investigation during its earnings call Thursday.

By Nick Paul Taylor • July 30, 2020

Baxter takes $180M revenue hit in thick of COVID-19

While acute therapies saw over 40% growth during the quarter, sales in Baxter’s advanced surgery, medication delivery and pharma businesses were hurt by lower rates of hospital admissions and elective surgeries.

By Greg Slabodkin • July 30, 2020

Falling FDA personnel costs soften 2021 medical device user fee hike

The agency’s required user fees for medical device submissions will rise 7.2% beginning in October.

By Nick Paul Taylor • July 30, 2020

Dexcom nixes plan to begin G7 launch this year

After growing revenues 35% in Q2, the diabetes tech company is focused on building out manufacturing for its continuous glucose monitoring systems and re-emphasizing its direct-to-consumer advertising.

By Maria Rachal • July 29, 2020

Boston Scientific sees sharp US recovery in Q2, CEO says ‘procedures can’t be deferred forever’

Organic revenue was down 29% during the quarter but beat analyst estimates, thanks in part to new patients in the pipeline and procedures performed in outpatient settings.

By Maria Rachal • July 29, 2020

FDA finalizes guidance on multiple-function devices after industry feedback

The agency clarified its policies and regulatory practices governing devices that have at least one distinct function and one other purpose that is not subject to premarket review.

By Susan Kelly • July 29, 2020

Smith & Nephew falls short of expectations, citing COVID-19 headwinds

The medtech’s sales slumped in the second quarter, causing first-half trading profit to miss analyst consensus by $53 million. Though CEO Roland Diggelmann called July a “good” month, he opted against sharing guidance.

By Nick Paul Taylor • July 29, 2020

Robot redux: Pandemic scrambles competitive timelines for Intuitive, J&J, Medtronic

Surgeons expect a gradual recovery of robot-assisted procedure volumes in the back half of the year, but the outlook for new robot system placements in hospitals is less optimistic due to freezes in capital equipment budgets.

By Susan Kelly • July 28, 2020

Medtech and COVID-19: 6 months into the public health emergency

MedTech Dive examines where the industry stands with testing and the future of those emergency use-authorized diagnostics, as well as how it’s adapting to a rebound in elective surgeries and various supply chain challenges.

July 27, 2020

Medtechs reboot with patients, providers after elective surgeries bottom out

Recovery of procedures critical to device companies came quicker than many in the industry expected. Now, device makers are adapting as business volumes normalize and COVID-19 continues to spread.

By Maria Rachal • July 27, 2020

How COVID-19 is challenging and changing medtech supply chain management

Four experts share insights on the supply and demand hangups medtechs have been working through during the pandemic, and a few early takeaways the industry can carry forward.

By Maria Rachal • July 27, 2020

COVID-19 diagnostics emerging as prime investment target, SVB analysis shows

Companies with tech involved in the pandemic response raised $1.3 billion over the first half of the year, with developers of tests and R&D tools enjoying a 62% increase in investment.

By Nick Paul Taylor • July 24, 2020

Edwards aims for 5% TAVR sales growth in 2020 after seeing demand bounce back

Quarterly sales came in $25 million above the top end of the device maker’s guidance, with 90% of its active sites having done TAVR procedures in May and June. Yet, there are concerns regarding a slowdown in new patient screenings.

By Nick Paul Taylor • July 24, 2020

HHS renews COVID-19 public health emergency

The extension supported by AdvaMed, the American Clinical Laboratory Association and American Hospital Association takes effect Saturday and opens the door for FDA to keep issuing emergency use authorizations.

By Shannon Muchmore • July 23, 2020

Medical device deal values down 88% amid COVID-19 disruption: PwC

Going forward, M&A may rise in light of recent deferral of elective procedures, which analysts say “could create the need for significant consolidation as companies work to remain competitive.”  

By Nick Paul Taylor • July 23, 2020