Digital Health

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

Sponsored by Alexander Group

How leading commercial organizations will ramp upon re-open

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

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 • 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

Deep Dive

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 07, 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 06, 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 01, 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 08, 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 • April 07, 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 02, 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 at 9:42 a.m.

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 • March 17, 2020

HIMSS20 canceled over coronavirus concerns

"Cancellation is unavoidable in order to meet HIMSS' obligation to protect the health and safety of the global HIMSS community," conference organizers told vendors Thursday.

By Rebecca Pifer • March 05, 2020

Uber Health targets provider pain points with revamped platform

The ride-hailing giant is attempting to address gripes with its non-emergency medical transportation service through a handful of new features that began rolling out late last year.

By Rebecca Pifer • March 04, 2020

Element Science raises $146M to fund rival to Zoll's wearable LifeVest

Deerfield Healthcare and Qiming Venture Partners USA led the round, joining investors Third Rock Ventures and Google Ventures​ to bring to market Element's wearable defibrillator.

By Nick Paul Taylor • March 04, 2020

Livongo tops Q4 estimates with contributions outside of diabetes

In its third quarterly earnings report since going public in 2019, the digital health company said its total diabetes members doubled from a year ago and its hypertension and pre-diabetes platforms are gaining traction.

By Susan Kelly • March 03, 2020

California's new cybersecurity law sidesteps most medical devices, lawyers say

How the state enforces its "internet of things" or connected devices law "may end up becoming a source of persuasive authority for the FDA in its decision making" on cybersecurity guidance, said White and Williams' Joshua Mooney.

By Fred Donovan • Feb. 28, 2020