Digital Health
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Permission granted by iRhythm
iRhythm's future hazy after Medicare pricing saga erases 12-month high
Wall Street analysts project the cardiac wearables maker to lose tens of millions of dollars in revenue in coming years, raising questions about the future of the once-hyped market leader.
By Ricky Zipp • April 13, 2021 -
Getty
Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance
The medtech is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying polyps and lesions.
By Greg Slabodkin • April 12, 2021 -
Explore the Trendline➔
Kendall Davis/MedTech Dive, original photos courtesy of Abbott and Dexcom
TrendlineThe MedTech Dive Outlook on 2021
The pandemic will keep disrupting the industry in the year ahead, as COVID-19 testing wanes and elective procedures slowly ease back. We look at the risks, challenges and opportunities.
By MedTech Dive staff -
Permission granted by iRhythm
iRhythm shares tank after Medicare rates surprise
CEO Michael Coyle said the wearables company will withdraw its Zio XT cardiac monitor from Medicare fee-for-service segments, adding that he was not optimistic for a reversal.
By Ricky Zipp • April 12, 2021 -
Deep Dive
Medtronic's robotic spine market lead threatened as smaller rivals look to edge in
Medtronic and Globus Medical are currently in a "two pony race" in the space, but market share can be stolen as other companies launch systems and adoption grows.
By Ricky Zipp • April 09, 2021 -
Adobe Stock
Fewer heart tests ordered for telehealth patients in pandemic
Research published in JAMA Network Open also found those using the virtual services were more likely to be Asian, Black or Hispanic.
By Susan Kelly • April 06, 2021 -
Adeline Kon/Healthcare Dive/MedTech Dive
Digital health funding hits new high after Q1 rich in megadeals
U.S. digital health companies raised a record $6.7 billion in the first quarter of 2021, putting the industry on track to easily top the $14 billion in investment last year.
By Nick Paul Taylor • April 06, 2021 -
UCLA engineer calls for mitigation of biases of medical devices
The perspective in the journal Science comes as the FDA has warned of social biases in data used to train artificial intelligence and bias against Black patients using pulse oximeters.
By Nick Paul Taylor • April 05, 2021 -
Jacob Bell
Liquid biopsies dominate FDA's latest breakthrough device nods
Cancer tests feature heavily in the latest round of agency breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status.
By Nick Paul Taylor • April 05, 2021 -
Stryker, Zimmer make data and analytics a top priority as robotic procedures ramp up
Through partnerships with big tech or developments of smart implants, the orthopaedic companies say tapping troves of patient data is the next logical strategic step.
By Ricky Zipp • March 25, 2021 -
Dollar Photo Club
Drugmakers flock to Vineti's fix for a cell, gene therapy problem
The San Francisco-based tech company wants to establish a patient identifier akin to a digital ID badge that could work for all types of advanced medicines and improve traceability, control costs and better ensure patient safety.
By Jacob Bell • March 24, 2021 -
Baxter, digital health startups lead pushback against 510(k) exemptions
Companies argued in public comments that relaxing certain FDA regulations could put consumer safety at risk. Roche was a rare supporter, arguing the changes would "free up much needed FDA resources."
By Nick Paul Taylor • March 23, 2021 -
Insulet's Omnipod 5 trial shows benefits across patient groups with Type 1 diabetes
The long-awaited results showed a reduction in blood sugar levels and increase in daily time spent in desired blood sugar ranges for younger and older patients. Wall Street analysts called the findings expected but still strong.
By Ricky Zipp • March 22, 2021 -
Kendall Davis/MedTech Dive, original photos courtesy of Abbott and Dexcom
CGM patients seen rising 38% in 2021 fueled by Type 2 diabetes: poll
Dexcom and Abbott are expected to benefit the most from the booming space, while Medtronic is expected to lose ground in the Type 1 market, according to an SVB Leerink survey of 101 endocrinologists and nurse practitioners.
By Ricky Zipp • March 18, 2021 -
Gorodenkoff via Getty Images
FDA touts real-world evidence use by Abbott, Medtronic in analysis of regulatory decisions
The agency has released details of how medtechs have used RWE, such as registries and medical records, to support filings including 510(k) submissions and premarket approval applications.
By Nick Paul Taylor • March 17, 2021 -
Adeline Kon/MedTech Dive
Deep DiveAll eyes on elective care after a rollercoaster year for medtech
After shutdowns slammed procedure-dependent firms in 2020, industry and Wall Street are waiting to see when non-emergency surgeries return and what a comeback might look like.
By Ricky Zipp • March 16, 2021 -
Deep Dive
5 things medtech can expect from FDA in 2021
"What you saw under the prior administration was this concept of a kinder, softer FDA to industry," said Dennis Gucciardo, partner at Morgan Lewis. Experts now expect a shift, including more enforcement activity.
By Greg Slabodkin • March 15, 2021 -
Cardiac wearables, iRhythm, under a cloud as reimbursement questions linger
"If this [Novitas Solutions] rate is not adjusted, these companies don't make money and will be unlikely to provide the service," Baird analyst Mike Polark said.
By Ricky Zipp • March 15, 2021 -
Courtesy of Quest Diagnostics
Quest eyes $2B DTC testing potential to capitalize on 'breakout' consumer growth
The lab giant's next move is to start selling an $89 at-home fecal test, targeting the colorectal cancer screening market led by Exact Sciences' Cologuard.
By Nick Paul Taylor • March 12, 2021 -
Vast majority of hospitals say they have an AI strategy, up from just half last year
AI technologies have also caught the attention of the medical device industry, with top medtechs like Medtronic, GE Healthcare and Philips investing in the space.
By Rebecca Pifer • March 10, 2021 -
Courtesy of BD/PRNewswire
BD, Abbott using apps to ease COVID-19 antigen test data bottlenecks
Both companies are using apps to capture and store testing data with public health agencies. The U.S. government has invested hundreds of millions of dollars to increase antigen testing, but data sharing hurdles remain.
By Nick Paul Taylor • March 10, 2021 -
Courtesy of Abbott
Abbott capitalizes on digital health boom with virtual clinic for neuromodulation therapy
The FDA-approved virtual clinic is the medtech giant's next step to gain share in the neurmod market from rivals Medtronic, Boston Scientific and Nevro.
By Nick Paul Taylor • March 09, 2021 -
Backing for telehealth Medicare reimbursement gains steam in Congress
Tuesday's House committee mirrored similar Senate panels. There's bipartisan support for a permanent expansion to a greater share of the population, but legislators are split on what form it should take.
By Rebecca Pifer • March 05, 2021 -
Insulin pump adoption seen climbing 21% in 2021 on wearables boom: survey
The SVB Leerink poll of 101 endocrinologists and nurse practitioners also projects a shift in market position among top players like Medtronic, Insulet and Tandem Diabetes Care.
By Ricky Zipp • March 05, 2021 -
Warchests, distressed assets drive medtech M&A flurry early in 2021
The industry is averaging more than one $100 million-plus takeover a week, as the influx of COVID-19 test revenues and pressures on companies reliant on surgical procedures create buying opportunities.
By Nick Paul Taylor • March 05, 2021 -
Getty Images
FDA lays out data modernization action plan
"Even small advances in our ability to gain useful insights from data can represent significant opportunities," Janet Woodcock and Amy Abernethy, respectively FDA's acting commissioner and acting CIO, wrote.
By Nick Paul Taylor • March 04, 2021
