Wall Street backs Stryker-Vocera strategic fit but split on valuation

The nearly $3 billion buy values Vocera at about 11.5 times higher than expected 2022 revenue, leading some analysts to question the overall price.

By Ricky Zipp • Updated Jan. 7, 2022

iRhythm's Medicare pricing saga defined its 2021

The cardiac monitor maker had a series of setbacks following Novitas Solutions' Medicare rate cut, including a stock free fall and a new CEO resigning after 4 months. Here's our coverage of iRhythm in 2021. 

Dec. 30, 2021

User growth, product delays and a Super Bowl ad: Diabetes tech heads into 2022 after another eventful year

Diabetes tech companies are heading into 2022 with momentum as insulin pump and CGM use climbs and with key product launches on the horizon. Here are MedTech Dive's top sector stories in 2021.

Dec. 28, 2021

Cerner acquired by Oracle for $28B

The deal further pushes Oracle into the healthcare market, where its presence is mostly in data use efficiency for payers and providers. Oracle's areas of focus include database software and cloud systems.

By Shannon Muchmore • Dec. 21, 2021

3 medtech markets poised to thrive in 2022 despite renewed COVID-19 pressures

While the emergence of the omicron variant is muddying next year's medtech outlook, analysts have identified three niches within the sector best positioned to successfully weather the continued strains on the healthcare system.

By Susan Kelly • Dec. 15, 2021

Roundup: Baxter completes $10.5B Hillrom acquisition

Wall Street analysts have questioned the price and strategic fit of the deal, which is the largest medtech buy so far in 2021.

Dec. 14, 2021

Tandem Diabetes Care targets 1M customers by 2027

The insulin pump maker expects to triple its installed units over the next five years behind new product launches and capturing market share as use among Type 1 and Type 2 patients is projected to take off.

By Ricky Zipp • Dec. 7, 2021

Cancer treatments lead latest FDA breakthrough device designations

The agency granted regulatory privileges to therapies for lung cancer and bone metastases from RefleXion Medical and Zetagen Therapeutics, respectively.

By Nick Paul Taylor • Dec. 7, 2021

Medicare telehealth visits increased 63-fold from 2019 to 2020, new government data shows

Virtual visits for Medicare beneficiaries went from hundreds of thousands pre-pandemic to tens of millions in 2020, with many beneficiaries using telehealth for the first time.

By Rebecca Pifer Parduhn • Dec. 6, 2021

Cyber playbook sets out strategies for modeling threats to medical devices

The FDA-funded guide arrives against a backdrop of calls from the agency for the medtech industry to step up its threat modeling throughout the device lifecycle in order to strengthen cybersecurity and patient safety.

By Nick Paul Taylor • Dec. 1, 2021

Roundup: COVID-19 surge, hospital labor shortages, supply chain issues hit medtechs in latest earnings

After the industry began recovering in the first half of the year, top companies reported that the delta variant surge put a drag on businesses last quarter.

Nov. 23, 2021

Latest breakthrough device designations go to brain-computer interface, exo-suit

Regulatory privileges were awarded to Blackrock Neurotech's brain-computer interface, designed to assist immobile patients with performing activities, and ReWalk Robotics' exo-suit, which is intended to help stroke patients walk. 

By Nick Paul Taylor • Nov. 22, 2021

New iRhythm CEO talks Medicare pricing, larger medtech competitors, international markets

"I think the near-term noise is something that we'll work through, but the underlying technology has never been questioned," Quentin Blackford told MedTech Dive.

By Ricky Zipp • Nov. 19, 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

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

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

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

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

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

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

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

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