Digital Health
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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 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 -
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 -
Food and Drug Administration
FDA launches years-in-the-making digital health center
The center's focus areas will include the Pre-Cert program, AI and machine learning in software as a medical device, as well as cybersecurity and wireless medical devices.
By Susan Kelly • Sept. 23, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Cellex, Gauss ally to develop fully at-home, app-enabled COVID-19 antigen test
The first company to receive an FDA nod for a coronavirus antibody test is pairing its 15-minute antigen test with a smartphone app to automate interpretation of results. There might be a higher likelihood of false negatives.
By Nick Paul Taylor • Sept. 17, 2020 -
NIH funds up to $23M to IBM, Evidation and others for COVID-19 digital health tech
Seven entities will receive money to work on detecting coronavirus cases and identifying their contacts by leveraging data from smartphones and wearables.
By Nick Paul Taylor • Sept. 16, 2020 -
Getty Images
FDA touts lessons from Pre-Cert, though next steps murky
Apple, Fitbit and Johnson & Johnson are among nine companies in the pilot launched in 2019 to fast-track digital health products to market. But there's no end in sight as tests continue.
By Greg Slabodkin • Sept. 15, 2020 -
Courtesy of Fitbit
Fitbit wins FDA clearance for EKG app
The nod brings the wearables giant up to speed with Apple and Samsung in the heart rhythm tracking arena.
By Rebecca Pifer • Sept. 14, 2020 -
Apple
Smartwatch EKGs could speed diagnosis of deadly heart syndrome, small study suggests
Some medical groups have questioned the use of wearables like the Apple Watch to detect certain conditions, but authors writing in JAMA Cardiology said they may be useful when an electrocardiogram is not available.
By Susan Kelly • Sept. 01, 2020 -
Medtronic artificial pancreas gets FDA nod for young kids
The medtech is introducing MiniMed 770G, a Bluetooth-enabled version of the first hybrid closed looped system to get agency approval, bridging the gap to a device launching in Europe this fall but delayed in the U.S.
By Nick Paul Taylor • Sept. 01, 2020 -
Clinical trial links hospital use of Dexcom G6 to improved glucose control
Scripps Whittier Diabetes Institute researchers found the sensors safe and effective in the hospital setting, newly cleared by FDA amid the pandemic. Whether the benefits justify the additional cost is unclear.
By Nick Paul Taylor • Aug. 28, 2020 -
Fotolia
Google Health, Philips among players pitching digital therapeutics standards
HP, Livongo and ResMed are also part of the effort led by the Consumer Technology Association to identify best practices to guide growth in the emerging field as COVID-19 drives demand for home-based treatments.
By Susan Kelly • Aug. 26, 2020 -
Courtesy of Fitbit
Fitbit launches smartwatch as EKG feature awaits FDA's OK
The device, which includes a skin temperature sensor and a heart rate tracker, comes as wearables are being trialed as early warning devices for COVID-19.
By Rebecca Pifer • Aug. 25, 2020 -
Fotolia
Surgical robots, early cancer tests top CB Insights digital health startup list
The most promising, as aggregated in annual rankings from the firm, have raised over $20 billion in total funding for more than 600 deals with 900-plus investors.
By Hailey Mensik , Maria Rachal • Aug. 14, 2020 -
Medtronic to buy Companion Medical, adding connected insulin pen to diabetes unit
Building on tuck-in acquisitions to a business losing market share in recent years, the deal gives the medtech giant an FDA-cleared device for people with Type 1 or Type 2 diabetes on multiple daily injection therapy.
By Greg Slabodkin • Aug. 11, 2020 -
Fotolia
ResMed beats Street with ventilators driving revenue up 9%, but tailwinds ebbing
"While we are still working on current and future contracts with hospitals, as well as city and national health authorities for these ventilators, the volumes will be significantly lower in the September quarter," said CEO Mick Farrell.
By Greg Slabodkin • Aug. 05, 2020 -
iRhythm stock leaps 33% after CMS pitches new reimbursement codes
Permanent codes validate the digital health company's wearable heart monitoring technology and could drive more widespread adoption for detection of atrial fibrillation and other abnormal rhythms, CEO Kevin King said.
By Susan Kelly • Aug. 05, 2020
