Forging trust in AI, sustaining the virtual care boom and other CES takeaways

"You can't just set a piece of software in front of somebody and say 'trust me,'" Christina Silcox, digital health fellow at the Duke-Margolis Center for Health Policy, said at the consumer tech conference.

By Rebecca Pifer • Jan. 19, 2021

MedTech Europe calls for EU to retain support for digital health post-pandemic

The industry wants reimbursement changes and other measures to make digital health permanent.

By Nick Paul Taylor • Jan. 19, 2021

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Philips to acquire Capsule Technologies in $635M deal, growing patient data capabilities

The move follows the medtech giant's $2.8 billion acquisition of cardiac monitoring company BioTelemetry in December, one of 2020's largest deals.

By Ricky Zipp • Jan. 19, 2021

Neuromod portfolios advance at Medtronic, Boston Scientific, Abbott

The flurry of activity is further evidence of the medtech industry’s latest attempts to make progress in a sector criticized as stagnant just one year ago.

By Nick Paul Taylor • Jan. 15, 2021

Google calls Fitbit acquisition complete despite ongoing DOJ review

The search giant closed the deal because the department's 14-month investigation period expired without any objection. However, DOJ could still sue to unwind the buy.

By Rebecca Pifer • Jan. 14, 2021

Remote monitoring, wearable companies look to capitalize on virtual care boom: JPM21

Diabetes players Dexcom and Insulet both projected business growth and market expansion for this year during presentations.

By Ricky Zipp • Jan. 14, 2021

CMS breakthrough rule called tailwind for Abbott, J&J and Medtronic

The policy gives developers of FDA-designated breakthrough products coverage for Medicare's 60 million beneficiaries on the day of approval.

By Nick Paul Taylor • Jan. 13, 2021

Medtech M&A to take off after pandemic slowed deals in 2020: EY

Dealmaking in 2021 will be fueled by financial firepower across the industry at an "all-time high" of nearly $500 billion, according to the consultants.

By Ricky Zipp • Jan. 10, 2021

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

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

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

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