Digital Health: Page 24
-
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 Parduhn • 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 Parduhn • 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 Parduhn • Feb. 19, 2021 -
COVID-19 leads to explosion in cyberattacks, data breaches
A survey from CI Security found successful hacks involving healthcare organizations or their business associates soared in the second half of last year, leading to a jump in the number of breached patient records.
By Ron Shinkman • Feb. 12, 2021 -
Courtesy of Dexcom, Nick Jonas Super Bowl kit
Dexcom touts boost from Super Bowl ad, sidesteps access complaints
While acknowledging concerns of the diabetic community, CEO Kevin Sayer said the company has a business to run and "by making more people aware" of CGMs "we'd have a much more positive effect than negative."
By Ricky Zipp • Feb. 12, 2021 -
Abbott, Medtronic could benefit as spinal cord stim seen rebounding
Physicians plan to prescribe 28% more implants than last year, driving sales above the high hit in 2019, according to a survey of 50 doctors by Baird Equity Research.
By Nick Paul Taylor • Feb. 12, 2021 -
Dexcom's Super Bowl ad puts focus on cost, access issues in diabetes tech
The maker of continuous glucose monitors deflected the criticism, calling the ad an education move to improve access for patients. Questions remain regarding how pricing impacts access to potentially life-saving devices.
By Ricky Zipp • Feb. 9, 2021 -
Pandemic habits could cause US health spending to decelerate over 2 decades, Deloitte predicts
The consultancy's predictive modeling based its estimate on the rise of digital health products and more consumer engagement. Such a slowing contrasts more dire spending forecasts made prior to the COVID-19 crisis.
By Rebecca Pifer Parduhn • Feb. 8, 2021 -
Roundup: Medtech earnings season continues to show COVID-19 uncertainty
BD, Quest Diagnostics and Roche all said they have a clearer view of the first quarter of 2021 but not the second half of the year, while Boston Scientific forecast electives pressure in the first quarter recovering in the second half.
Feb. 5, 2021 -
Jacob Bell/MedTech Dive
FDA appoints first medical device cybersecurity chief
University of Michigan professor Kevin Fu will serve a one-year term as acting cyber director at the Center for Devices and Radiological Health. Experts fear the chaos of the pandemic creates the perfect storm for hackers to exploit.
By Greg Slabodkin • Feb. 3, 2021 -
[Photograph]. Retrieved from Regional Health Command Atlantic.
From COVID-19 EUAs to 'insidious' remote care risks: ECRI's top 10 medtech hazards
Risks highlighted by the watchdog include FDA emergency use authorizations and the rapid adoption of telehealth, both of which have increased during the coronavirus pandemic.
By Susan Kelly • Feb. 1, 2021 -
Adeline Kon/MedTech Dive
4 key trends for medtech in 2021
With resurgence of the coronavirus and emergence of more contagious strains, COVID-19 challenges, but also opportunities, lie ahead for medical device and diagnostics companies.
By Greg Slabodkin • Jan. 29, 2021 -
Deep Dive
3 big predictions for digital health in 2021
As tech and data sharing become more pervasive, healthcare will likely pivot to being more predictive and telehealth will evolve, giving rise to new modalities of care. This will force companies to invest more in cybersecurity.
By Rebecca Pifer Parduhn • Jan. 29, 2021 -
Low Medicare EKG device draft slams iRhythm, stock price sinks by over 30%
Wall Street analysts questioned whether the lower-than-expected rates are final and what the prospects are for renegotiation. Shares of market leader iRhythm fell over 32% on Friday.
By Ricky Zipp • Updated Feb. 1, 2021
Previous
