Zimmer sees Q1 sales growth after CEO warned of down quarter

Bryan Hanson cautioned in February the quarter would be more challenging than the fourth due to COVID-19 pressures. The turnaround led the company to issue full-year 2021 guidance, but investors weren't impressed.

By Ricky Zipp • May 4, 2021

Radiology Partners, Aidoc talk AI adoption, handling bias, FDA actions

While AI and machine learning technologies have gained popularity in the medtech and healthcare industries, the companies intend to further grow usage in radiology with their recent partnership.

By Ricky Zipp • May 3, 2021

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

Orthopaedic companies project 'return to normalcy' as electives recover in Q1

J&J, Smith & Nephew and Stryker reported seeing a light at the end of the tunnel during the first quarter as nonessential care rebounded, with a backlog of hip procedures pointing the way forward.

By Susan Kelly • May 3, 2021

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

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