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

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

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

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

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

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

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

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

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. 9, 2020