Intuitive sees Q1 robot rebound in turnabout from start of year

CEO Gary Guthart called the quarter a "step in the right direction," but execs also cautioned variants and supply chain constraints could throw a wrench into the recovery.

By Susan Kelly • April 21, 2021

Edwards withstands winter lows, grows Q1 sales on electives recovery

CEO Michael Mussallem said volumes grew gradually through March after a significant drop, continuing the early trend of procedure-dependent medtechs reporting a return of non-emergency procedures.

By Ricky Zipp • April 21, 2021

Explore the Trendline➔

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

Health funding shatters records in Q1, but medtech a bit of a laggard

Medical device companies were a relative outlier, raising $4.6 billion, down 23% from a peak in the fourth quarter last year, while the number of deals declined by almost 11%, according to a CB Insights report.

By Rebecca Pifer • April 20, 2021

Abbott misses Wall Street as COVID-19 test sales softer than expected

CEO Robert Ford told investors on Tuesday that $1.8 billion in sales were from its rapid coronavirus testing platforms as he sees a shift to surveillance. But he acknowledged testing is "difficult to forecast right now." 

By Greg Slabodkin • April 20, 2021

J&J returns to growth in Q1 as elective care rebounds in US, Asia-Pacific

The recovery was mixed among procedure types, with hips improving, while knees and spine fell. Still, CEO Alex Gorsky forecast volumes to keep rebounding throughout 2021.

By Ricky Zipp • April 20, 2021

AdvaMed pushes CMS to implement MCIT final rule without further delay

The Medicare agency postponed the proposal from taking effect amid criticism from some doctors and safety groups that it risks promoting device use without rigorous evidence of safety and effectiveness.

By Susan Kelly • April 19, 2021

FDA drops 8 medical software functions from oversight

The final rule, issued without notice or comment, brings the software classifications in line with provisions of the 21st Century Cures Act and reflects the agency's current statutory authority.

By Susan Kelly • April 19, 2021

BD files new 510(k) submission for troubled Alaris infusion pump

The announcement comes after a spate of software and hardware recalls regarding the Alaris system throughout 2020 and 2021.

By Ricky Zipp • Updated April 26, 2021

Robotics startup Vicarious raises $425M, including from BD, to take on giants

Aiming for a 510(k) submission in 2023 and to grow sales to $1 billion by 2027, the firm with high-profile backers including Bill Gates will face competition from Intuitive, J&J and Medtronic.

By Nick Paul Taylor • April 16, 2021

FDA scraps Trump-era 510(k) exemption bid in scathing dissection of 'flawed' plan

The agency nixed the proposal, which HHS made without consulting FDA, after strong pushback from Baxter and digital health startups, among other stakeholders, as well as its own staff.

By Nick Paul Taylor • April 16, 2021

EU MDR delay has not made new rules easier to stomach: exec poll

Most of the 115 respondents to the Climedo Health survey said resources and lack of clarity were top challenges, with about a third indicating compliance efforts will cost their company 5% to 10% of annual revenue.

By Ricky Zipp • April 15, 2021

6 medtechs to watch when earnings kick off next week

First quarter results from Abbott, Edwards, Intuitive, J&J, Quest and Roche will help reveal the pace of procedure recovery and if the coronavirus testing boom has legs despite the rollout of vaccines. 

By Nick Paul Taylor • April 15, 2021

FDA authorizes labs for device conformity testing pilot

The accredited laboratories will assess whether medical devices meet consensus standards. None of the initial 53 labs, which include TÜV SÜD and UL, have so far received accreditation for biocompatibility testing.

By Nick Paul Taylor • April 14, 2021

Mid-sized medtechs hit hardest by pandemic, though sector seen resilient: poll

The survey of more than 1,600 industry professionals from Emergo by UL also found respondents are most bullish on tapping Asian markets.

By Nick Paul Taylor • April 14, 2021

HHS urged to conduct 'vigorous oversight' of hospital price rule after reports of noncompliance

U.S. lawmakers want the secretary to step up oversight of the new requirement for health systems to make prices for procedures like hip and knee replacements available to the public.

By Samantha Liss • April 14, 2021

iRhythm's future hazy after Medicare pricing saga erases 12-month high

Wall Street analysts project the cardiac wearables maker to lose tens of millions of dollars in revenue in coming years, raising questions about the future of the once-hyped market leader.

By Ricky Zipp • April 13, 2021

Doubts cast on CPAP efficacy evidence in HHS agency review

A report prepared for the Agency for Healthcare Research and Quality found available studies "mostly" do not support a link between continuous positive airway pressure therapy and long-term, clinically important outcomes.

By Nick Paul Taylor • April 13, 2021

Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance

The medtech is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying polyps and lesions. 

By Greg Slabodkin • April 12, 2021

iRhythm shares tank after Medicare rates surprise

CEO Michael Coyle said the wearables company will withdraw its Zio XT cardiac monitor from Medicare fee-for-service segments, adding that he was not optimistic for a reversal.

By Ricky Zipp • April 12, 2021

FDA puts Medtronic Valiant Navion stent graft recall in Class I category

The action, which comes amid one patient death in a clinical trial, deprives Medtronic of a source of sales growth. After securing 2018 approval, then-CEO Omar Ishrak talked up the device's potential to drive incremental growth.

By Nick Paul Taylor • April 12, 2021

Orthopaedic surgeons see slow volume recovery from COVID-19, tip Stryker to gain in poll

The 200 U.S. physicians surveyed by UBS analysts expect the medtech to pick up share in knees and hips but are downbeat on the prospects of Smith & Nephew in both of the segments.

By Nick Paul Taylor • April 9, 2021

Medtronic's robotic spine market lead threatened as smaller rivals look to edge in

Medtronic and Globus Medical are currently in a "two pony race" in the space, but market share can be stolen as other companies launch systems and adoption grows.

By Ricky Zipp • April 9, 2021

MDMA, surgeons push Medicare to pull back prior authorization rules

The medtech lobby and 39 stakeholders warned CMS that including cervical fusion with disc removal and implanted spinal neurostimulators as new service categories will delay patient access to medically necessary procedures.

By Greg Slabodkin • April 8, 2021

12 deaths linked to Class I recall for Medtronic's HeartWare HVAD

The recall was first made public in the FDA's database on April 6. Medtronic provided a different accounting of total patient deaths as of January and said the company is redesigning parts.

By Nick Paul Taylor • Updated April 16, 2021

Suit alleging Medtronic misled FDA over spine fusion can proceed, appeals court says

The court ruled the case can go forward on the question of whether the medtech defrauded the agency to gain 510(k) clearance for several products by failing to disclose the devices were intended for use in cervical spine.

By Susan Kelly • April 7, 2021