In FDA 1st, game-based therapeutic gets marketing OK

Digital therapeutics developer Akili Interactive Labs won De Novo authorization for a treatment meant to improve attention function in children with ADHD, building on a rollout it began under a special COVID-19 policy.

By Maria Rachal • June 16, 2020

Heart rhythm bodies see 'clear concerns' with using wearables to detect arrhythmias

A paper published on Monday by the Heart Rhythm Society, along with counterpart groups in Asia, Europe and Latin America, found wearable-triggered false positives can cause unwarranted concerns and screening.

By Nick Paul Taylor • June 16, 2020

Siemens Healthineers, Geisinger ink 10-year digital health partnership

It's one of the medtech's largest partnerships of its kind in North America, as it plans to provide diagnostic imaging and artificial intelligence-enabled applications to the health system over the next decade.

By Greg Slabodkin • June 9, 2020

BARDA, Evidation team on early detection of COVID-19 using wearables

As part of an agency program to identify people infected with the virus, the company will analyze sleep and activity data, plus self-reported symptoms, aimed at creating an early warning algorithm.

By Nick Paul Taylor • June 5, 2020

Pandemic causes expected wearable shipments to plummet by 27M this year

But analysts expect a drawn-out recovery for the sector as wearables bolster their advanced health monitoring features and consumers remain increasingly health-conscious coming out of the COVID-19 crisis.

By Rebecca Pifer Parduhn • June 4, 2020

Emergency authorization granted to COVID-19 ICU prediction software

The FDA nod for CLEW Medical's system is among a series of regulatory OKs for products designed to inform care for infected patients.

By Nick Paul Taylor • May 28, 2020

How leading commercial organizations will ramp upon re-open

Increased agility helps healthcare commercial leaders adapt to a new buyer journey.

May 27, 2020

ResMed, Medtronic embrace remote tech amid COVID-19, say it's here to stay

The crisis has sped adoption of digital health technologies to help hospitals create safe physical distances between healthcare workers and patients. Execs say some could become permanent products.

By Greg Slabodkin • May 26, 2020

Philips lung ultrasound, Beckman sepsis diagnostic receive BARDA coronavirus backing

The separate projects aim to incorporate machine learning algorithms to enhance technologies meant to support COVID-19 patients.

By Susan Kelly • May 19, 2020

UnitedHealth, Microsoft launch COVID-19 screening app for employers

The healthcare behemoth said it will control employees' medical data and manage opt-in and consent requirements for users. The app will not provide tracking or contact tracing information.

By Rebecca Pifer Parduhn • May 15, 2020

Philips, startups look to deploy new ultrasound tech amid coronavirus

The need for point-of-care imaging for lung and cardiac complications among COVID-19 patients has led to a flurry of expedited FDA reviews.

By Nick Paul Taylor • May 14, 2020

Eko algorithm gets FDA nod for cardiac screening of COVID-19 patients

Developed with the Mayo Clinic, Eko's algorithm gained breakthrough device status in December and review was further accelerated given its potential to identify patients at higher risk of poor outcomes with the coronavirus.

By Nick Paul Taylor • May 13, 2020

Telehealth is having a moment. What does its future look like after COVID-19?

Employers should expect workers to embrace telehealth post pandemic, sources told HR Dive, even if concerns about billing and security persist.

By Ryan Golden • May 7, 2020

Fitbit launches its 1st large-scale, virtual AFib study

The atrial fibrillation detection effort follows work by wearables rival Apple targeting the stroke risk factor that affects 33.5 million people globally.

By Greg Slabodkin • May 6, 2020

COVID-19 spurs 'incredible demand' for ventilators, buoying ResMed's 16% revenue uptick

CEO Mick Farrell told investors sales of breathing assist machines added $35 million in coronavirus-related revenue. However, sleep testing declined by double digits.

By Greg Slabodkin • May 1, 2020

FDA encourages remote review of digital pathology slides amid COVID-19

The agency's latest effort to support greater access to medical devices during the pandemic follows a move by CMS that opened the door for pathologists to work away from the lab.

By Susan Kelly • April 27, 2020

Digital therapeutic makers see opportunity as pandemic prompts FDA to ease rules

Akili Interactive Labs is rolling out its video game treatment for ADHD for the first time, while Pear Therapeutics weighs how products still in its pipeline may apply during the coronavirus crisis.

By Maria Rachal • April 24, 2020

Harvard, INSEAD authors pitch systemic regulatory approach to AI/ML devices

A new paper in Nature's digital medicine journal argues that real-world performance of specific SaMD products using artificial intelligence will vary considerably by hospital and other factors.  

By Nick Paul Taylor • April 8, 2020

Digital health rakes in record $3.1B in Q1, but coronavirus slump may loom

"Though some of the economic blow will be tempered by demand for connected healthcare, we do not anticipate investment activity to keep pace with Q1 levels in the coming months," a new Rock Health report says.

By Rebecca Pifer Parduhn • April 7, 2020

FDA clears Sectra's digital pathology module for primary diagnostics as US market heats up

The clearance will intensify competition in the space initially monopolized by Philips, with big medtechs like Roche aiming to enter. The ability to review images from anywhere may be critical amid the coronavirus pandemic.

By Nick Paul Taylor • April 2, 2020

In Pre-Cert 1st, FDA clears app-based treatment for chronic insomnia

Pear Therapeutics, one of nine initial participants in an FDA pilot that rethinks software regulation, touted the product as the first to be submitted through the 510(k) pathway while also reviewed as part of Pre-Cert.

By Maria Rachal • March 27, 2020

Digital health advice from FDA amid coronavirus leaves more questions than answers

While the agency doesn't consider most apps and software systems for COVID-19 public health surveillance and communication to be regulated medical devices, the scope of regulation remains murky.

By Greg Slabodkin • March 27, 2020

FDA still trying to fine-tune Pre-Cert as pilot enters 2020

The Pre-Cert​ pilot, which includes Apple, J&J and Fitbit, is moving forward with the agency "working through the nine companies, trying to figure out how they actually do business," FDA's Bakul Patel told MedTech Dive.

By Greg Slabodkin • March 25, 2020

CDRH pushes out response due date extensions, teleconference policy by at least a month

Less than two weeks after FDA wrote to industry extending deadlines for premarket application responses and warning of disruptions to in-person meetings, the agency lengthened those coronavirus-era changes.

By Maria Rachal • Updated April 6, 2020

Disease management firms set to capitalize on Trump admin interoperability push

A key detail of a rule finalized last week could make it simpler for Omada Health, Propeller Health and Livongo to interface with large health system clients.

By Rebecca Pifer Parduhn • March 17, 2020