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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.

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.

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.

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.

FDA labels Ellume's recent COVID-19 Home Test recall Class I event

The agency said there have been 35 reports of false positive results but no deaths reported. More than 2.2 million devices are being recalled in the U.S.

Updated 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.

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.

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.

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.

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.

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. 

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.

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.

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.

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.

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.

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.

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.

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.

Thermo Fisher, Hologic ride wave of COVID-19 test demand, for now

The two lateral flow assay companies reported strong coronavirus testing sales in the latest quarter. However, Hologic CFO Karleen Oberton told investors late Monday the pandemic remains unpredictable.

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.

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. 

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.

ResMed reaffirms Philips recall is up to $350M boost but held back by supply chain struggles

"Supply bottlenecks continue to restrict our access to critical electronic components, especially semiconductor chips, that ultimately limit our net production output,” CEO Mick Farrell told investors late Thursday.

Updated Oct. 29, 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.