Digital Health: Page 25
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Color raises $167M to scale up US testing and telehealth services
The health technology company, with a valuation of $1.5 billion, intends to use the money to help build a national tech-based public health infrastructure capable of providing healthcare services to large populations.
By Nick Paul Taylor • Jan. 5, 2021 -
Philips clinical-grade wearable study in early COVID-19 detection gets DoD funds
The project will assess the FDA-cleared BioSticker, coming a week after the Dutch medtech giant doubled down on remote patient monitoring by scooping up BioTelemetry for $2.8 billion.
By Nick Paul Taylor • Dec. 23, 2020 -
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 -
Medtronic, GE, Philips embrace AI amid regulatory limbo around algorithms
The focus comes as FDA action seems stalled. It's been a year and a half since the agency issued a discussion paper on its proposed regulatory framework for machine learning-based software as a medical device.
By Greg Slabodkin • Dec. 21, 2020 -
Medtech's COVID-19 recovery will have to wait for second half of 2021: analysts
Wall Street expects declines in elective care to continue as coronavirus cases keep rising. However, a more widespread rollout of vaccines could spur momentum later in the year.
By Ricky Zipp • Dec. 21, 2020 -
Philips buys cardiac monitoring company BioTelemetry in $2.8B deal
The Dutch conglomerate said that the move will expand its remote patient monitoring business beyond the hospital space. Baird called the pact a surprise but the valuation fair.
By Ricky Zipp • Dec. 18, 2020 -
CDRH headed for 'reset' in 2021 after COVID-19 derailed priorities, Shuren says
After a "massive increase" in work due to the pandemic, the device center anticipates continuing to manage coronavirus projects while also focusing on MDUFA V and new programs.
By Ricky Zipp • Dec. 3, 2020 -
Everlywell raises $175M to expand at-home health testing, virtual care services
The startup was first to win FDA emergency approval for a COVID-19 test self-collection kit. Sales of most tests are growing more than 100% year over year, driven by deals with Target, Walgreens and CVS, though competition is rising.
By Nick Paul Taylor • Dec. 3, 2020 -
iRhythm goes back to drawing board as CMS reverses national pricing move
In a departure from an August proposal, the agency will leave it up to local contractors to determine pricing for new permanent codes reimbursing the EKG patches service. Shares fell 24% after the news late Tuesday.
By Maria Rachal • Dec. 2, 2020 -
Medtechs, working with FDA, offer guidance for remote control of medical devices during pandemic
GE Healthcare, Medtronic, Philips and ResMed are among those that have modified products with such capabilities to create safe physical distance between providers and COVID-19 patients.
By Greg Slabodkin • Dec. 2, 2020 -
Digital therapeutic De Novos climb with FDA nod to IBS treatment
Despite a series of first-of-their-kind authorizations for such tech, total 2020 De Novo OKs currently match a 2019 low in recent years.
By Maria Rachal • Dec. 1, 2020 -
Permission granted by iRhythm Technologies
iRhythm gains UK support for EKG system while awaiting key final rule from CMS
The ambulatory cardiac monitoring system is one of just six medtech products recommended this year in guidance from the U.K. National Institute for Health and Care Excellence. The focus is on individuals with suspected arrhythmias.
By Maria Rachal • Dec. 1, 2020 -
Fitbit data suggests potential for early COVID-19 detection using wearables
While the algorithm would generate far more false than true positives even when prevalence is high, researchers argue it could encourage more testing and precautions. The results have yet to be validated in a prospective study.
By Nick Paul Taylor • Dec. 1, 2020 -
CMS expands ability for hospital-level care at home ahead of holiday virus spread
Six health systems received waivers to treat more than 60 acute conditions under the new program, which also tweaks earlier changes allowing ambulatory surgical centers to provide greater inpatient care.
By Shannon Muchmore • Nov. 30, 2020 -
Healthcare deals in Q4 predicted to fall from record-setting Q3: report
Market research firm CB Insights believes the drop will carry over into the digital health sector too, an area that's seen historic investor interest in 2020 amid the coronavirus pandemic.
By Rebecca Pifer • Nov. 25, 2020 -
Jacob Bell/MedTech Dive
Breast cancer tech among FDA's latest breakthrough nods
Over the past month, designations for speedier review have also ranged from a migraine treatment to tissue regeneration tech for spinal cord injuries.
By Susan Kelly • Nov. 24, 2020 -
iRhythm wearable linked to more afib diagnoses, though road to payer uptake called 'grind'
Analysts were broadly encouraged by the new data, while cautioning that unlocking the market for this population will take time. Wall Street took a wait-and-see approach, with the stock closing down 9% on Tuesday.
By Nick Paul Taylor • Updated Nov. 18, 2020 -
Remote trials, US-Israel device partnership among pitches in FDA, HHS funding bills
The Senate appropriations committee released a series of budget proposals for fiscal 2021. FDA's device center is slated for a 5% funding increase, making it one of the only centers set to receive less than requested.
By Nick Paul Taylor • Nov. 11, 2020 -
Courtesy of Intuitive Surgical
What Intuitive is looking for through its new $100M venture fund
Surgical robots have been Intuitive's sweet spot. As the company moves into VC for the first time, its broader focus on minimally invasive care, including interest in digital tools and precision diagnostics, opens more opportunities.
By Maria Rachal • Nov. 9, 2020 -
Courtesy of Nightware
FDA greenlights digital therapeutic for Apple Watch to quell PTSD nightmares
The device, from Minneapolis-based startup Nightware, monitors heart rate and body movement data to best deliver vibrations that interrupt a nightmare without waking the person sleeping.
By Susan Kelly • Nov. 9, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
MDUFA V talks kick off as FDA grapples with onslaught of COVID-19 submissions
Medtech industry groups broadly expressed a desire to maintain the status quo after FDA Commissioner Stephen Hahn described the strain on agency workers under MDUFA IV as unsustainable.
By Maria Rachal • Oct. 28, 2020 -
FDA, Philips warn of data bias in AI, machine learning devices
The comments come 18 months after FDA unveiled a yet-to-be-finalized framework for modifying AI/ML-based software as a medical device using real-world learning and adaptation.
By Greg Slabodkin • Oct. 26, 2020 -
Neuromod devices at the fore in latest FDA breakthrough designations
Liquid biopsies also stand out as an area where U.S. regulators are encouraging development and prioritizing review.
By Nick Paul Taylor • Oct. 23, 2020 -
FDA floats framework to message cybersecurity threats to patients
The proposal, which has the agency and industry sharing responsibility for making the information easy to find, comes as the risks to medical devices continue to grow.
By Nick Paul Taylor • Oct. 21, 2020 -
FDA
AdvaMed seeks regulatory clarity on FDA's new digital health center
Director Bakul Patel says the new unit aims to provide the "least burdensome" oversight and that evidence will be key, but industry says medtechs still have questions on what rules they're subject to.
By Greg Slabodkin • Oct. 20, 2020 -
Robotic surgery startups help drive Q3 medical device funding over $5B, an all-time high
CB Insights also listed the progress of neuromodulation devices and Medtronic's deals in diabetes and neurosurgery as other highlights.
By Nick Paul Taylor • Oct. 20, 2020
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