FDA misses MDUFA V deadline after months of contentious talks

The agency has failed to send the final MDUFA V user fee agreement to Congress by the Jan. 15 deadline, suggesting there may be unresolved disagreements with industry over elements of the program.

By Nick Paul Taylor • Jan. 19, 2022

Digital therapeutics face barriers to growth as Pear takes early steps toward sales targets

Among the challenges facing DTx are lack of support for rapid updates, limitations of current reimbursement policies, cybersecurity risks as well as a "pressing need" for new regulatory frameworks, according to researchers.

By Nick Paul Taylor • Jan. 19, 2022

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

Dexcom CEO on G7's global launch, COVID-19 slowing new patient adds, international growth

Kevin Sayer spoke to MedTech Dive about the upcoming launch of the G7 CGM system, further expanding Dexcom ONE and feeling pandemic pressure in the fourth quarter.

By Ricky Zipp • Jan. 18, 2022

Abbott, BD, Quidel pursue DTC strategies amid 'paradigm shift' for at-home, self-testing

The three test makers said at last week's J.P. Morgan healthcare conference that they see opportunities for direct-to-consumer, digitally-connected testing for other diseases beyond COVID-19.

By Greg Slabodkin • Jan. 18, 2022

Medtech M&A, IPOs hit new highs as more buyers enter the space: SVB

In a new report, Silicon Valley Bank projects that medical device mergers and acquisitions "will stay hot, as a diverse set of acquirers compete for the top deals," but sees a slowdown in initial public offering activity.

By Nick Paul Taylor • Jan. 14, 2022

Neurological devices, diagnostics dominate latest FDA breakthrough designations

The agency has granted breakthrough designations to several devices for neurological conditions, including an autism test and treatment as well as diagnosis of Parkinson's disease.

By Nick Paul Taylor • Jan. 13, 2022

iRhythm stock jumps nearly 28% after Novitas doubles Medicare rates for cardiac monitoring

The new rates give the cardiac monitor maker a boost following a challenging 2021. After a Monday spike, iRhythm's stock price was also up by nearly 9% when the market closed Tuesday.

By Ricky Zipp • Jan. 11, 2022

Abbott targets consumer health, aims to turn diabetes success into wearable growth driver

The company is making a play for the wearables market with a line of patches that track the levels of biomarkers such as glucose, ketones and lactate. Abbott's push into the consumer space is part of a broader trend in medtech.

By Nick Paul Taylor • Jan. 7, 2022

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 • 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