CMS reinstates Medicare's inpatient-only list in final rule, reversing Trump-era nix

Medtronic, Johnson & Johnson, Stryker and Zimmer Biomet overwhelmingly supported restoring the IPO list in public comments to the July proposed rule. The backing comes as the industry also embraces outpatient care.

By Ricky Zipp • Nov. 3, 2021

Outset nabs first CMS home dialysis add-on payment, setting up fight with Fresenius

The company, whose application was rejected last year, persuaded the Medicare agency its portable dialysis machine is a "substantial clinical improvement" over the incumbent home-use hemodialysis product.

By Nick Paul Taylor • Nov. 3, 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

Safety of Endologix endovascular graft device center of FDA panel review

The medtech competes in a space targeted by companies including Cook Medical and Medtronic. Agency advisers will discuss the broader endovascular graft market Wednesday.

By Nick Paul Taylor • Nov. 2, 2021

Siemens' Varian leads latest FDA breakthrough device designations

Varian secured the regulatory privileges for its noninvasive treatment of knee osteoarthritis based on technology acquired from Boston Scientific. Magnus Medical, Renovia and MY01 are included in the latest batch of designations.

By Nick Paul Taylor • Nov. 1, 2021

With remote collaboration technology, busy device representatives can "be there" for diverse accounts across growing territories

Silicon Valley- based technology company, Avail Medsystems, offers an all-encompassing remote collaboration platform technology so device representatives can be in the room for procedures even when they can’t be there.

Nov. 1, 2021

3 trends dragging medtechs: Supply chain constraints, inflation and hospital staffing shortages

J&J, ResMed and Stryker are among the companies citing one of these factors as constraining growth in the current reporting season.

By Nick Paul Taylor • Nov. 1, 2021

FDA, global peers create guiding principles for AI/ML medical devices

The U.S., U.K. and Canada are seeking international harmonization as part of a broader discussion on the development of safe, effective devices that use artificial intelligence and machine learning.

By Nick Paul Taylor • Oct. 29, 2021

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

FDA restricts breast implant sales, cites Allergan and J&J for inadequate postapproval progress

The agency also made official a boxed warning, after an advisory panel heard from dozens of patients with a cancer associated with breast implants and symptoms of a related illness.

By Nick Paul Taylor • 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

Notified bodies join chorus of criticism of proposed European AI regs

Team-NB has come out strongly against the regulation, arguing it will add to administrative burdens, reduce notified body capacity and create confusion.

By Nick Paul Taylor • 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

Roche's refillable eye implant becomes Eylea's latest threat

The FDA has approved Susvimo, a device that continuously administers a version of Roche's Lucentis over several months. It could challenge Regeneron's top-selling drug.

By Ben Fidler • Oct. 25, 2021

EU task force calls for MDR legacy device surveillance requirements

The Medical Device Coordination Group said legacy devices are subject to rules on post-market surveillance, market surveillance and vigilance. Manufacturers need to create and maintain periodic safety update reports.

By Nick Paul Taylor • Oct. 25, 2021

Amazon teases 5 more cities to get virtual Amazon Care offering this year

Amazon Care is currently live in the Washington, D.C. and Baltimore area, and will be rolled out in Dallas, Chicago, Philadelphia, Boston and Los Angeles this year, the unit's director told the HLTH conference this week.

By Rebecca Pifer • Oct. 22, 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

Intuitive says delta variant slows Q3 da Vinci procedure growth

The robot-assisted surgery leader said the latest wave of COVID-19 cases curbed demand for non-emergency surgeries, especially in the U.S. South in states with low vaccination rates. 

By Susan Kelly • Oct. 20, 2021

In last ditch plea to save MCIT, medtech groups suggest fixes to CMS

AdvaMed and MDMA responded to a call for feedback on the planned repeal of the Medicare Coverage of Innovative Technology pathway by proposing tweaks and new ideas to salvage it.

By Nick Paul Taylor • Oct. 20, 2021

Over-the-counter hearing aids proposed by FDA

A Cowen analyst said the policy change would allow consumer electronics manufacturers to get into the lucrative hearing aid market that has been dominated by ReSound, Sonova and William Demant. 

By Greg Slabodkin • Oct. 19, 2021