BioCardia, Cook Medical land FDA breakthrough nods in latest designations

Cardiovascular devices feature prominently in the tech granted regulatory privileges, including a drug-eluting stent for patients with chronic limb-threatening ischemia and a non-invasive cardiac monitoring device. 

By Nick Paul Taylor • Feb. 9, 2022

Zimmer gives investors first look at its dental and spine spinoff

The new, independent company, called ZimVie, is expected to bring in about $1 billion in revenue this year. While the dental unit is expected to grow immediately, the spine unit is projected to drop initially.

By Ricky Zipp • Feb. 8, 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

Procedure volatility, testing uncertainty & FDA delays: Medtech trends in 2022

As companies manage through the omicron surge, and with the threat of potential future variants, the medical device industry is facing another challenging year.

Feb. 4, 2022

3 key FDA topics for medtechs in 2022

While the agency is looking to get back to normal operations this year, COVID-19 is poised to remain a top priority and, once again, thin resources for more traditional work, such as product reviews.

By Ricky Zipp , Greg Slabodkin • Feb. 1, 2022

FDA must improve medical device interoperability through data standards: JAMA

The authors list a range of potential positive outcomes of improved device interoperability, using the experience of the consumer technology and telecommunications industries to make their case.

By Nick Paul Taylor • Jan. 31, 2022

4 key trends for procedure-reliant medtechs in 2022

Medical device companies likely will face the same challenges this year that they have been dealing with since the pandemic's start, such as procedure volatility and hospital staffing shortages.

By Ricky Zipp • Jan. 27, 2022

FDA finalizes two guidances on including patient perspectives in medtech clinical trials

The documents, which elaborate on how to engage patients to improve trial design and use patient-reported outcomes, are based on feedback from groups like AdvaMed which raised concerns about "significant" legal issues.

By Nick Paul Taylor • Jan. 26, 2022

The shifting digital health investment landscape in 2022

Signs point toward another historic year in VC investment, experts say, which will benefit the medical system as it evolves to include more digital services.

By Rebecca Pifer • Jan. 25, 2022

Medtronic's HawkOne recall labeled Class I, adding to medtech's product safety problems

FDA posted 10 Class I recall notices for Medtronic in 2021 and three so far this year. CEO Geoff Martha addressed the recalls and an FDA warning letter at the J.P. Morgan conference, claiming the company will increase accountability.

By Ricky Zipp • Jan. 21, 2022

Digital health funding jumps to new high as investors bet big on mental health startups: report

The explosive growth was driven by digital therapeutics and mental health technology, both of which saw capital inflows more than double compared to 2020, according to a new CB Insights report.

By Nick Paul Taylor • Jan. 21, 2022

Tandem CEO on Omnipod 5 competition, pharmacy distribution, Type 2 growth

John Sheridan spoke to MedTech Dive about international growth, creating an insulin pump system for Type 2 patients and what Insulet's Omnipod 5 launch and Medtronic's FDA warning letter mean for Tandem.

By Ricky Zipp • Jan. 20, 2022

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

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