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 Elise Reuter • March 2, 2022 -
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 Elise Reuter • Feb. 25, 2022 -
Explore the Trendline➔
Permission granted by Roy MendiolaTrendlineMedTech 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 -
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 Nick Paul Taylor • 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 Ricky Zipp • Updated May 12, 2022 -
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 Ricky Zipp • Feb. 18, 2022 -
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 Elise Reuter • Feb. 17, 2022 -
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 Elise Reuter • Feb. 14, 2022 -
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 Ricky Zipp • Updated March 14, 2022 -
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 -
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 -
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 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 -
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 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 -
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 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 -
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 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 -
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 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