CMS finalizes joint replacement pricing extension with input from medtech industry

Cowen analysts say the agency's initiative could evolve in ways that put pressure on the prices of orthopaedic devices. However, they contend companies can mitigate that threat by selling more products to customers.

By Nick Paul Taylor • April 30, 2021

Smith & Nephew returns to growth as US hip sales surge

First quarter orthopaedic results saw divergent performance in the knees and hip franchises. CEO Roland Diggelmann noted hip injuries are typically more acute but acknowledged a gap in its U.S. knee portfolio.

By Nick Paul Taylor • April 29, 2021

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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

Stryker's Wright costs spur Q1 miss, but robotics orders pick up

The medtech also raised its full-year earnings outlook, which CFO Glenn Boehnlein said is based on an assumption that the second quarter "has a return to normalcy by the time we get to the end."

By Susan Kelly • April 28, 2021

Boston Scientific sees Q1 electives rebound, hints at further 2021 M&A

With two acquisitions already in 2021, CFO Daniel Brennan said, "We have the appetite, and we have the balance sheet in place to continue to" spend later this year.

By Ricky Zipp • April 28, 2021

CMS pitches extra year of add-on payments for Boston Scientific, Stryker, other devices

Boston Scientific's Eluvia drug-eluting stent, Cook Medical's Hemospray and Stryker's SpineJack system are among those that would get the extension under the proposed fiscal 2022 inpatient hospital rule.

By Nick Paul Taylor • April 28, 2021

GE Healthcare grows sales as routine screening, elective procedures return

The results provide further evidence that the resumption of elective procedures has driven up demand for imaging and other healthcare products and services. GE saw volumes return for cardiac, oncology and neurology screening.

By Nick Paul Taylor • April 27, 2021

Philips raises guidance as elective procedures exceed pre-pandemic levels

The Dutch conglomerate's results follow encouraging rebounds in non-emergency care from Edwards, Intuitive Surgical and J&J. Still, Philips posted a loss from continuing operations. 

By Nick Paul Taylor • April 26, 2021

FDA greenlights device to retrain muscles in stroke patients

The noninvasive brain-computer interface technology uses data from the uninjured side of a patient's brain to recover motor function in the affected arm and hand.

By Susan Kelly • April 26, 2021

Value-based care at 'critical juncture,' new CMMI chief says

Even though some testing payment models have been delayed or discarded, the new leader of CMS' innovation arm said the agency remains committed to finding models that reward value over volume.

By Rebecca Pifer • April 23, 2021

Survey casts doubt on utility of wearable devices in healthcare

Forrester's report, based on interviews with doctors, patients and vendors, suggests data gaps and physician skepticism of the popular products is too high for widespread adoption, although design changes could remedy that.

By Ron Shinkman • April 22, 2021

Moody's predicts brisk pace of medtech M&A amid earnings optimism

A new report from the ratings agency echoes initial commentary by bellwethers J&J and Edwards, which released financials this week.

By Susan Kelly • April 22, 2021

Roundup: Medtech earnings show early signs of electives return, lingering testing uncertainty

The industry is reporting an elective care rebound in March after volumes dropped in the winter, while COVID-19 test demand appears to be softening as vaccination numbers grow.

April 22, 2021

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

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