CMS implementation of breakthrough payment rule may be further delayed: Cowen

The agency will most likely push the start date back further to address the concerns of critics of the contentious Medicare Coverage of Innovative Technology initiative, an analyst contends.

By Nick Paul Taylor • May 10, 2021

TAVR readmission rates vary widely between hospitals for unknown reasons: study

Length of stay and discharge disposition only explained 15% of the inter-hospital variation. The study's authors have called for efforts to identify practices associated with low rates or readmission. 

By Nick Paul Taylor • May 10, 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

Robotic surgery outlook boosted by hospital spending pickup in Q1

Intuitive and Stryker said that system buys were stronger than expected in the first quarter. Zimmer also reported momentum for its Rosa system, while Globus had positive early feedback for its robotic spine technology.

By Susan Kelly • May 10, 2021

With MDR nearing, EU updates guidance on transition to Eudamed database

The European Union no longer requires reporting obligations to be carried out as soon as the database becomes fully functional. The Medical Device Regulation takes effect May 26 and Eudamed will come online one year later.

By Nick Paul Taylor • May 7, 2021

iRhythm again meets with Medicare rate setter after cardiac monitoring pay cut by nearly $200

CEO Michael Coyle said during a Thursday earnings call the company has met with Novitas Solutions to discuss a different pricing methodology. Investors seemed encouraged as shares were up nearly 8% Friday morning.

By Ricky Zipp • May 7, 2021

FDA shares plan for restarting facility inspections, warns backlog will persist into 2022

In a projected base-case scenario, the agency expects to have cleared 26% of its backlog of medical product inspections by October. A total of 2,426 device and radiological health inspections remain for fiscal year 2021.

By Nick Paul Taylor • May 7, 2021

Nevro raises outlook as neuromodulation market recovers from COVID-19 crisis

Improvements during the quarter, which culminated in Nevro's best March ever, emboldened the company to target at least 22% growth in 2021. Still, the company's stock price dropped by about 6% Thursday morning.

By Nick Paul Taylor • May 6, 2021

BD grows Q2 revenue despite COVID-19 test dip, spins off diabetes business

The spin off for the separate publicly traded company is expected to be completed in the first half of calendar year 2022. The move will not impact BD's ability to fulfill orders related to COVID-19 vaccinations, execs said.

By Greg Slabodkin • May 6, 2021

AI, digital health feature in latest batch of FDA breakthrough device designations

The agency granted regulatory privileges to artificial intelligence products, including software designed to enable the early detection of cancer and technology to help surgeons tell if cancer is still present after surgical excision.

By Nick Paul Taylor • May 5, 2021

Newer TAVR devices linked to lower rate of permanent pacemaker use: study

The 1,987-subject study found patients receiving older transcatheter heart valves, such as Edwards Lifesciences' Sapien and Medtronic's CoreValve, required permanent pacemakers at a higher rate than newer-generation THVs.

By Nick Paul Taylor • May 5, 2021

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

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