What does J&J's Ottava delay mean for Intuitive and Medtronic? It's complicated.

The setback doesn't remove hurdles the rivals face playing catch-up to market leader Intuitive's da Vinci, which has a two-decade head start. 

By Ricky Zipp • Oct. 28, 2021

Edwards TAVR volumes tepid in October, quashing hopes of fast recovery from delta

"We didn't want to send a signal that all of a sudden October is back to the kind of thing that we were experiencing in Q2. We're not experiencing that kind of an environment yet," CEO Mike Mussallem told investors Wednesday.

By Nick Paul Taylor • Oct. 28, 2021

Boston Scientific CEO projects better Q4 and 2022 as delta surge wanes

Michael Mahoney was optimistic that procedure volumes will rebound as the variant subsides and vaccination rates rise. However, the CEO acknowledged pressure from a "spotty" COVID-19 recovery and hospital staffing shortages.

By Ricky Zipp • Oct. 27, 2021

FDA's 2022 A-list guidance plan hits on software, post-pandemic future

The agency's priorities include a much-anticipated final guidance on clinical decision support software — more than five years in the making — meant to clarify when CDS meets the definition of a medical device.

By Nick Paul Taylor • Oct. 27, 2021

Like 'Whac-A-Mole': GE Healthcare says supply chain woes to last into 2022

"I'm not sure we're yet in a place where we would say that things are stable," GE CEO Larry Culp told investors Tuesday. The healthcare unit took the biggest hit among the conglomerate's business lines due to delays.

By Greg Slabodkin • Oct. 26, 2021

Zimmer, J&J chase Stryker's lead in ortho robotics

"I don't think it's a market share battle as much as market expansion. All the companies are riding this wave," said Needham & Co. analyst Mike Matson.

By Susan Kelly • Oct. 25, 2021

Tenet sees widespread volume recovery, again raises forecast

Despite the operating challenges poised by COVID-19 in the third quarter, the for-profit health system was able to manage through the headwinds, executives said Thursday during a call with investors. 

By Samantha Liss • Oct. 22, 2021

Abbott, Intuitive, J&J set tone for earnings: Testing up, procedures down

The medtechs in recent days confirmed the mixed financial impact of the delta wave and early signs of recovery in elective procedures in the U.S. Reports from Boston Scientific and Stryker come next week.

By Nick Paul Taylor • Oct. 21, 2021

Medtronic surgical robotics head talks Hugo, taking on Intuitive, COVID-19 challenges

Megan Rosengarten spoke to MedTech Dive about challenging Intuitive Surgical's 20-year lead in soft tissue robotics, growing global robotics usage and the stress of entering a new market amid COVID-19.

By Ricky Zipp • Oct. 20, 2021

Abbott COVID-19 sales rebound, but calls market too volatile for 2022 forecast

CEO Robert Ford warned investors that despite a big uptick driven by the delta surge, "we'll have to update on a rolling quarterly basis."    

By Greg Slabodkin • Oct. 20, 2021

J&J delays Ottava robot rollout as global medtech business boosts Q3 sales

The healthcare giant was the first procedure-dependent medtech to announce earnings this quarter, potentially foreshadowing what others in the industry will report in the coming weeks.

By Ricky Zipp • Oct. 19, 2021

Abbott software causing COVID-19 test false positives, starts Class I recall fix

FDA said use of the tests before the problem is corrected may cause serious adverse health consequences or death, alerting laboratories to treat the results as presumptive and that they may need to be confirmed with another test.

By Nick Paul Taylor • Oct. 19, 2021

Biden circling former FDA chief Califf to again lead agency: report

The Washington Post reported the administration was "closing in" on the choice, citing unnamed sources. Still, the White House declined to comment and Califf could face opposition from Senate Democrats.

By Ricky Zipp • Oct. 15, 2021

Medtronic pledges R&D boost, brand refresh, amid rising Big Tech rivalry

CEO Geoff Martha said the device giant is still "building out that direct-to-consumer muscle" and acknowledged "healthy competition" with the likes of Apple and Google.

By Greg Slabodkin • Oct. 14, 2021

EU proposes to delay IVD Medical Device Regulation, citing COVID-19 backlog

Originally set to go into effect in May 2022, a progressive rollout is now planned. The proposal will now go to the European Parliament and Council for adoption, according to the announcement.

By Kim Dixon • Updated Oct. 14, 2021

Medtronic's surgical robot Hugo gains CE mark, setting up Intuitive faceoff

The system will hit the European market after the medtech giant unveiled it in 2019 and delayed the timeline amid the pandemic. Medtronic will take on market leader Intuitive Surgical and an upcoming product from J&J.

By Ricky Zipp • Oct. 11, 2021

4 takeaways from a bumper year of M&A medtech activity (so far)

After hunkering down last year, many companies entered 2021 with large cash reserves and acquisition targets that included players lacking scale to weather the downturn.

By Nick Paul Taylor • Oct. 11, 2021

Quidel hikes revenue forecast, riding COVID-19 testing wave

CEO Doug Bryant cautioned that "demand can change very quickly," while Craig-Hallum analysts said future coronavirus-related sales remain "unforecastable."

By Greg Slabodkin • Oct. 8, 2021

Labcorp, PerkinElmer latest to target COVID-flu combo test market

FDA gave a nod to Labcorp's diagnostic, which uses a Roche test for SARS-CoV-2, influenza A and influenza B. PerkinElmer's assay also got emergency authorization for those three viruses as well as respiratory syncytial virus.  

By Greg Slabodkin • Oct. 7, 2021

Medtechs opened 2021 with a flurry of M&A and have not stopped spending since

With deals ranging from tuck-ins to multibillion-dollar takeovers, here's a roundup of the M&A spree so far this year after activity came to a near halt amid the unpredictability of 2020.

Oct. 7, 2021

FDA labels Ellume's recent COVID-19 Home Test recall Class I event

The agency said there have been 35 reports of false positive results but no deaths reported. More than 2.2 million devices are being recalled in the U.S.

By Nick Paul Taylor • Updated Nov. 10, 2021

Acon gets FDA nod for home COVID-19 test kit amid surging US demand

The diagnostics maker secured authorization for its over-the-counter antigen test amid a nationwide testing shortage. Abbott and Quidel are scaling up production but it could take months to boost output.

By Nick Paul Taylor • Oct. 5, 2021

MCIT, cyber, RWE and 3 more takeaways from AdvaMed's 2021 conference

The medtech industry gathered virtually and in person for the lobby's annual conference, with topics ranging from the kill-off of the breakthrough device payment pathway to the pandemic upending CDRH's 2021 reset.

Oct. 4, 2021

CDRH's 2021 'reset' shunted again as COVID-19 dominates workload

Jeff Shuren, who spoke during AdvaMed's annual conference, said the heavy coronavirus workload will lead it to miss some MDUFA IV performance metrics.

By Greg Slabodkin • Sept. 28, 2021

Delta pressure on US hospitals dragged August operations, Kaufman Hall finds

"The August data show we are not out of the woods yet, and hospitals face additional uncertainties as we move into the fall and winter," said Erik Swanson, senior vice president of data and analytics for the consultant group.

By Rebecca Pifer • Sept. 28, 2021