Digital Health: Page 2


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    Sanofi strikes $30M strategic agreement with digital health company DarioHealth

    One of several digital health investments by the French pharma company, the five-year agreement will give DarioHealth access to Sanofi's sales teams and also involves integrating some of its partner's products.

    By March 2, 2022
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    CMS code seen as major step toward reimbursement for digital therapeutics

    Pear Therapeutics CEO Corey McCann said the agency's new HCPCS code for prescription digital behavioral therapy is an important milestone for getting digital therapeutics as a product category covered by more insurance plans. 

    By Feb. 25, 2022
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    MedTech Dive Outlook 2022

    The pandemic continues to disrupt the medical device industry early in 2022, as COVID-19 testing demand remains strong and nonemergent procedures are postponed. In this series, we look at the risks, challenges and opportunities ahead.

    By MedTech Dive staff
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    Roche's Foundation Medicine gets FDA breakthrough device nod in latest designations

    Breakthrough status was granted to Foundation Medicine's test to detect molecular residual disease in early-stage cancer after curative therapy. A liquid biopsy from Datar Cancer Genetics was also given the regulatory privileges.

    By Feb. 25, 2022
  • Diabetes tech leaders expect another year of growth, innovation as competition soars

    MedTech Dive spoke with diabetes technology leaders about what to expect in 2022, the impact of new products and the increasingly competitive market.

    By Updated May 12, 2022
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    Q&A

    Medtronic talks diabetes group's FDA warning letter, new products, supply chain constraints

    Ali Dianaty, VP of product innovation and operations for Medtronic Diabetes, spoke to MedTech Dive about the warning letter's impact on product reviews, creating insulin pump patches and navigating the pandemic.

    By Feb. 18, 2022
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    Baxter begins integrating Hillrom, faces supply chain pressures

    The recent omicron surge put a damper on the company's margins, as shipping costs and healthcare staff shortages rose. Baxter expects these problems to abate in the short term and sees a long-term boost from the Hillrom acquisition.

    By Feb. 17, 2022
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    Food and Drug Administration
    Q&A

    CDRH digital health chief talks new role with agency, future of the market

    Bakul Patel, the Center for Devices and Radiological Health's chief digital health officer, will help FDA meet its 2022-2025 strategic priorities and set regulatory policies for the new technologies such as AI and machine learning.

    By Feb. 14, 2022
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    Dexcom's G7 gains CE mark after 2021 delay

    The company’s newest continuous glucose monitoring system was expected to launch in Europe in 2021, but regulatory delays pushed the release back.

    By Updated March 14, 2022
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    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 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 Feb. 8, 2022
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    Abbott

    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
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    Deep Dive

    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 , Feb. 1, 2022
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    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 Jan. 31, 2022
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    Deep Dive

    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 Jan. 27, 2022
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    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 Jan. 26, 2022
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    Deep Dive

    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 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 Jan. 21, 2022
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    Q&A

    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 Jan. 20, 2022
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    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 Jan. 19, 2022
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    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 Jan. 19, 2022
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    Q&A

    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 Jan. 18, 2022
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    Abbott

    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 Jan. 18, 2022
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    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 Jan. 14, 2022
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    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 Jan. 13, 2022