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

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

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

Boston Scientific to begin limited US launch of latest Watchman device

The medtech hopes the updated version of its high-growth stroke technology will help boost its interventional cardiology unit as elective procedures pick back up.

By Maria Rachal • July 22, 2020

Intuitive plans to lower instrument prices as it warns of long recovery

The surgical robots maker reported a pullback in revenue and earnings as it weathers the one-two COVID-19 punch of delayed elective procedures and constrained capital equipment spending.

By Susan Kelly • July 22, 2020

AdvaMed launches COVID-19 test registry to address shortages

Created in partnership with Abbott, Roche, Siemens and others, the database is aimed at helping ensure sufficient testing supply by providing weekly state- and national-level updates on the number of tests shipped.

By Nick Paul Taylor • July 22, 2020

NuVasive surprises analysts with sooner-than-expected spine surgery sales rebound

Preliminary second quarter results show sales were down 30% year over year but were about a third higher than average analyst expectations, adding to evidence of a faster-than-predicted COVID-19 recovery in the medtech sector.

By Nick Paul Taylor • July 21, 2020

As pandemic rages on, hip and knee surgeons lay out elective procedure guidance

An international group of orthopaedic experts outlined recommended changes to hospital protocols to prevent transmission of COVID-19 when elective procedures resume.

By Susan Kelly • July 20, 2020

Philips sees double-digit COVID-19 connected care bump amid Q2 sales dip

Headwinds won out this spring, dragging total sales down 6%. Still, management predicted the return of elective procedures will help tip the balance to growth for the rest of the year.

By Nick Paul Taylor • July 20, 2020

Ambu wins FDA clearance for single-use duodenoscope product

Boston Scientific was first to obtain an agency nod for a fully disposable version, meant to be safer against infection, which it believes could be worth more than $1 billion.

By Maria Rachal • July 17, 2020

J&J drops planned 510(k) for Verb-Auris robot, targets 2022 clinical trial start

Talks with the FDA led Johnson & Johnson to opt against trying to bring its general surgery robotics platform to market via the 510(k) pathway. Launch delays buy market incumbent Intuitive some important time, analysts noted.

By Nick Paul Taylor • July 17, 2020

J&J device sales fell by one-third in Q2, but June rebound drives better 2020 outlook

Device sales in some areas returned to around 90% of pre-pandemic levels by the end of the quarter, causing J&J to improve its 2020 worst-case scenario for the division by $1.75 billion.

By Nick Paul Taylor • July 16, 2020