Biden nominates Robert Califf to return as FDA head

If confirmed, the cardiologist would return to lead an agency taxed by a heavy COVID-19 workload and a backlog of initiatives back-burnered amid the pandemic.

By Ned Pagliarulo , Jonathan Gardner • Updated Nov. 12, 2021

J&J splitting medical device, pharma units from consumer health brands

The industry giant and mainstay of corporate America will separate its consumer health business from its drug and medical device units, which will retain the J&J brand. 

By Ben Fidler , Ned Pagliarulo , Ricky Zipp • Updated Nov. 12, 2021

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

After another successful quarter, diabetes tech players look ahead to key product launches

Dexcom's new G7 CGM system is expected to gain CE mark clearance in Q4, and Insulet's Omnipod 5 insulin pump is on track for FDA clearance and a limited launch by the end of the year.

By Ricky Zipp • Nov. 11, 2021

Siemens software vulnerabilities potentially put millions of medical devices at risk

A U.S. cybersecurity agency issued an alert about the vulnerabilities which could allow hackers to disrupt the operation of anesthesia machines and bedside monitors from multiple manufacturers.

By Nick Paul Taylor • Nov. 11, 2021

Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use

AdvaMed and several device companies, including BD, Medtronic and Philips, have reiterated to the Biden administration how supply chain constraints are causing an "unsustainable" disruption to the industry.

By Nick Paul Taylor • Nov. 10, 2021

GE unveils plan to spin off healthcare business

The independent company, expected to be separated by early 2023, is being positioned as having more flexibility to pursue acquisitions as it sharpens its focus on precision health and struggles with supply chain shortages.

By Susan Kelly • Nov. 10, 2021

Coloplast acquires laryngectomy device maker Atos Medical in $2.5B takeover

With Atos claiming a more than 80% share of the laryngectomy market, Coloplast sees the company as a source of growth in the coming years.

By Nick Paul Taylor • Nov. 10, 2021

CMS repeals MCIT breakthrough device final rule, leaves open other coverage pathways

The agency on Friday officially rescinded the Medicare Coverage for Innovative Technologies rule due to safety concerns following strong opposition from some healthcare groups, despite strong support for the rule in the medtech industry.

By Nick Paul Taylor • Updated Nov. 12, 2021

Philips grows cardiac monitoring business with Cardiologs pickup

Nearly one year after announcing its $2.8 billion acquisition of BioTelemetry, the Dutch conglomerate is further expanding its reach in remote patient monitoring with the purchase of France-based Cardiologs.

By Susan Kelly • Nov. 9, 2021

Robotics startup Vicarious files pre-submission with FDA, fresh from $220M SPAC raise

The filing is part of a push to establish the robotic surgical system in a space fought over by Intuitive Surgical, Johnson & Johnson and Medtronic.

By Nick Paul Taylor • Nov. 9, 2021

Latest Abbott, Boston Scientific LAAC devices yield mixed results in first clinical comparison

No clear difference was evident in clinical outcomes at 45 days, but other endpoints did point toward potential pros and cons of the two left atrial appendage closure devices.

By Nick Paul Taylor • Nov. 8, 2021

Edwards, Medtronic bolster economic, clinical case for using TAVR over surgery

Medtronic released five-year data from the SURTAVI trial while Edwards presented a two-year study of the costs of TAVR and surgery, both of which were late-breaking clinical trials at the TCT annual scientific symposium.

By Nick Paul Taylor • Nov. 8, 2021

iRhythm's COVID-19 pressures add to Medicare pricing saga

New CEO Quentin Blackford told investors "significant" customer staffing issues are likely to drag on through Q4, limiting the company's capacity and forcing it to lower 2021 guidance.

By Ricky Zipp • Nov. 5, 2021

Stryker, Zimmer, Smith & Nephew warn orthopaedic headwinds to last into Q4

Third-quarter results reveal how the industry remains constrained by COVID-19, hospital staffing shortages and lower pricing in China. 

By Nick Paul Taylor • Nov. 5, 2021

FDA issues long-awaited draft software guidance in overhaul of 16-year-old policy

The proposal applies to all types of premarket submissions and includes both software in and Software as a Medical Device.

By Nick Paul Taylor • Nov. 4, 2021

Why are women more likely to use telehealth?

As Washington mulls over telehealth regulations post-COVID-19, it's important not to roll back access in a way that could disproportionately affect women, experts say.

By Rebecca Pifer Parduhn • Nov. 3, 2021

CMS finalizes plans for pay cuts for radiation oncology, other specialists

Device makers could feel the pinch in cuts to services that use pricey equipment for vascular surgery, interventional radiology and diagnostic testing, which AdvaMed contends will decrease patient access to care.

By Shannon Muchmore • Nov. 3, 2021

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

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