Stryker dismisses robotics threat from J&J, Zimmer with bullish forecast

CEO Kevin Lobo said during Thursday's analyst day that the company is "poised and ready to pounce" if valuations fall as Stryker looks to leverage M&A in long-term growth plans.

By Nick Paul Taylor • Nov. 19, 2021

Medtronic leadless pacemaker flagged by FDA for safety risks

The agency said in a letter to healthcare providers that cardiac perforations associated with Medtronic's Micra device are more likely than traditional pacemakers to be associated with serious complications, such as death.

By Nick Paul Taylor • Nov. 18, 2021

Explore the Trendline➔

Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

TAVR uptake in US cities tied to race, ethnicity and income: JAMA study

ZIP codes with higher proportions of Black, Hispanic and socioeconomically disadvantaged patients have lower rates of transcatheter aortic valve replacement procedures, according to an analysis of Medicare claims data.

By Nick Paul Taylor • Nov. 18, 2021

MCIT breakthrough device payment pathway included in Cures 2.0 bill

Lawmakers on Tuesday introduced a revised MCIT proposal in the next version of the 21st Century Cures Act, following last week's repeal of the final rule by CMS. Industry groups AdvaMed and MDMA both back the legislation.  

By Nick Paul Taylor • Nov. 17, 2021

Siemens Healthineers projects revenue jump fueled by Varian double-digit sales growth

The medtech expects its $16.4 billion Varian acquisition to post annual sales growth from 2023 to 2025, leading it to forecast accelerating revenue rises.

By Nick Paul Taylor • Nov. 17, 2021

Globus in takeover talks with NuVasive to boost spine portfolio: reports

Truist Securities and Piper Sandler analysts said the deal is unlikely. J.P. Morgan cautioned that earlier orthopaedic takeovers struggled to generate returns.

By Nick Paul Taylor • Nov. 16, 2021

What does J&J's split mean for the medical device business?

Analysts agree that shedding the consumer health group will help boost pharma and medical device growth. The healthcare giant's move follows two key medtech breakups announced in 2021: GE and Zimmer.

By Ricky Zipp • Nov. 16, 2021

BD's $2B annual M&A war chest, connected care devices at heart of growth plan

Evercore ISI analysts said the targets and messaging were consistent with expectations, while J.P. Morgan questioned why it is taking BD longer than its peers to return margins to pre-pandemic levels.

By Nick Paul Taylor • Nov. 15, 2021

FDA questions safety of Philips replacement foam for recalled devices

The agency has asked Philips Respironics to conduct more safety testing on the sound abatement foam at the center of the sleep apnea and ventilator device recall, but did not recommend that patients stop using the machines.

By Susan Kelly • Nov. 15, 2021

FDA panel finds need for surveillance of devices from Endologix, Medtronic and others

Experts convened earlier this month by FDA warned the risks of routine use of Endologix's current endovascular graft device outweigh the benefits.

By Nick Paul Taylor • Nov. 15, 2021

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

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