Digital Health
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Flickr: FDA, Michael J. Ermarth
Digital therapeutic De Novos climb with FDA nod to IBS treatment
Despite a series of first-of-their-kind izations for such tech, total 2020 De Novo OKs currently match a 2019 low in recent years.
By Maria Rachal • Dec. 01, 2020 -
Permission granted by iRhythm
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. 01, 2020 -
Fitbit
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. 01, 2020 -
Getty Images
CMS expands ability for hospital-level care at 网络百家家乐真人视频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 -
Jp Valery for Unsplash
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 / BioPharma 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 at 10:11 a.m. -
Phil Roeder, Flickr
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. 09, 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. 09, 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
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 -
Getty Images
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 -
Getty
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 -
Flickr; The U.S. Food and Drug Administration
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 -
Fotolia
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 -
Philips
Philips Q3 connected care sales up 42%, but ventilators to decline next year
The company expects the COVID-19 tailwinds, including double-digit growth in patient monitors and ventilators, to extend through the fourth quarter but fall away in 2021.
By Greg Slabodkin • Oct. 19, 2020 -
Cancer testing drives 2020 medtech IPO surge after slow start
A flurry of activity began in June, including from China-based Burning Rock and Genetron and U.S.-based Progenity.
By Nick Paul Taylor • Oct. 12, 2020 -
Courtesy of AdvaMed
5 key exec insights from 2020's MedTech Conference
Top leaders from Abbott, BD, Medtronic, Stryker and Zimmer Biomet shared the latest on the industry's recovery during the pandemic and thoughts on where it goes from here.
By Maria Rachal • Oct. 09, 2020 -
Flickr; Phalinn Ooi
Avail raises $100M to let medtech reps remotely oversee surgeries
The Series B funding comes weeks after Smith & Nephew claimed to be the first orthopaedics company to use the telemedicine service.
By Nick Paul Taylor • Oct. 08, 2020 -
Brian Tucker
'Tragedy' if FDA doesn't extend COVID-19 lessons beyond pandemic, Shuren says
Device head Jeff Shuren acknowledged the regulatory paradigm for medical devices is more than 40 years old and "not well suited for many modern-day technologies," speaking at AdvaMed's Virtual MedTech Conference.
By Greg Slabodkin • Oct. 07, 2020 -
Courtesy of Cleveland Clinic
App-connected pacemakers, telehealth among Cleveland Clinic top 2021 innovations
Medtronic's MyCareLink Heart pacemaker smartphone app is one example of the four medtech developments making the annual top 10 list of medical breakthroughs.
By Nick Paul Taylor • Oct. 07, 2020 -
Courtesy of Amwell
Amid pandemic, specialty telehealth outpaces urgent care, Amwell poll says
Willingness to use virtual care notably doubled in a handful of high-volume fields like radiology, cardiology and surgery, the survey found.
By Rebecca Pifer • Oct. 06, 2020 -
Adobe Stock
AdvaMed sends CMS reform wishlist to boost digital health device coverage
The medtech industry group argues changes are needed for Medicare to realize the potential of a sector projected to be worth $500 billion by 2026.
By Nick Paul Taylor • Oct. 02, 2020 -
COVID-19 spurred a medtech M&A boom this summer. Will it last?
Siemens Healthineers' CEO was rebuffed by his counterpart at Varian in January. But come May, the impact of coronavirus began to become clear.
By Nick Paul Taylor • Sept. 30, 2020
