Digital Health: Page 23
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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 6, 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 6, 2021 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 5, 2021 -
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 5, 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 -
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 -
Alex Wong via Getty Images
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
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 -
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Deep Dive5 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 9, 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 5, 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 5, 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 5, 2021 -
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 4, 2021 -
Hillrom steps back from $375M BardyDx deal on reimbursement setback
The hospital products maker said a Medicare contractor's unexpected drop in payment rates for BardyDx's cardiac monitoring technology meant closing conditions for the transaction had not been satisfied.
By Susan Kelly • March 1, 2021 -
Permission granted by iRhythm Technologies
iRhythm still faces reimbursement uncertainty after meetings with Medicare rate negotiator
CEO Michael Coyle said the cardiac monitoring company and other industry representatives met with a Medicare Administrative Contractor twice, but added that there are no assurances rates will come up.
By Ricky Zipp • Feb. 26, 2021 -
Diabetes wearables look resilient through 2021, bucking broad medtech trends
Dexcom, Tandem and Insulet pointed to targeting Type 2 patients and DTC as growth drivers in posting year-end results. One analyst gushed that "the golden age of diabetes care is still here."
By Ricky Zipp • Feb. 25, 2021 -
Google opening office near Mayo Clinic campus to galvanize tech collaboration
The goal of the business venture is to form an "AI factory" churning out algorithms and other digital products in a variety of clinical specialties.
By Rebecca Pifer • Feb. 19, 2021
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