Digital Health: Page 2

Insulet’s Omnipod 5 insulin delivery system approved for preschool children

Adding preschoolers will broaden the market for the Omnipod after the launch of the device for people aged six years and older helped Insulet boost U.S. sales by 31% in the second quarter.

By Nick Paul Taylor • Aug. 23, 2022

Akili raises $163M in ‘blank-check’ merger, plans to commercialize digital treatment for ADHD

Akili’s share price fell as much as 55 percent on the Nasdaq by mid-morning Monday, its first day of trading after merging with a special purpose acquisition company.

By Elise Reuter • Aug. 22, 2022

Explore the Trendline➔

Medical device industry continues to turn to digital health, AI

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

By MedTech Dive staff

Visibly wins FDA clearance for self-administered online vision test

The agency has placed restrictions on the test, limiting it to adults aged 22 to 40 years and cautioning that it only gives “supportive recommendations.”

By Nick Paul Taylor • Aug. 17, 2022

Smartphone-linked blood pressure monitors fail to beat traditional devices, study finds

Individuals have been able to check their blood pressure at home using devices that lack connectivity features for years, raising the question of whether the technology improves outcomes.

By Nick Paul Taylor • Aug. 16, 2022

Pear Therapeutics trims workforce, forecast as state contracts move slower than expected

After a restructuring in July, the company is focused on bringing in more paying customers.

By Elise Reuter • Aug. 12, 2022

Friday Q&A: Francine Kaufman, Senseonics’ CMO, talks growing users, a 365-day CGM, doctor recruitment

Kaufman spoke about Senseonics’ release of its 180-day CGM in the U.S., developing a unique product in the diabetes technology market and competing with Dexcom and Abbott.

By Ricky Zipp • Aug. 12, 2022

Insulet raises forecast as Omnipod 5 sales climb; Tandem expects tougher market in second half

Both insulin pump companies grew revenue by more than 10% in the second quarter, but Tandem lowered its 2022 forecast amid a tougher market, while Insulet increased its guidance.

By Ricky Zipp • Aug. 11, 2022

Roundup: Medical device industry confident it can ride out recession, wary of slowing capital sales

While companies may weather a recession, they still face challenges like hospital staffing shortages, supply chain disruption and inflation, RBC Capital Markets analysts wrote.

By Nick Paul Taylor • Updated Aug. 10, 2022

Senate passes $740B bill to lower healthcare costs after months of wrangling

While Republicans successfully challenged a planned $35 insulin price ceiling for patients on private insurance, the law still has implications for makers of diabetes devices.

By Nick Paul Taylor • Aug. 8, 2022

FDA’s breakthrough device designations poised for another record year

At the midpoint of the year, the FDA had granted 129 designations, suggesting it will break the previous full-year record of 206.

By Nick Paul Taylor • Aug. 8, 2022

iRhythm raises 2022 revenue forecast after record number of registrations in Q2

The cardiac monitor maker increased the low end of its forecast by $5 million, although executives expect a flat third quarter compared to the second quarter due to macroeconomic pressures.

By Ricky Zipp • Aug. 5, 2022

ResMed buys Mementor for prescription digital health app, continuing German expansion

ResMed will integrate the startup into its German operation as a separate business segment and use it as a platform for further digital health development.

By Nick Paul Taylor • Aug. 4, 2022

Dexcom’s G7 glucose monitor delayed until late 2022; stock price drops 5.6%

The CGM maker needs to update software for the product, pushing back the FDA’s decision and eventual U.S. release.

By Ricky Zipp • July 29, 2022

Pear Therapeutics restructures, looks to slash development costs

The digital therapeutics company is looking to cut down on the development of new product candidates to focus on near-term commercialization plans.

By Elise Reuter • Updated July 28, 2022

iRhythm, Alphabet unit Verily get FDA clearances for Zio Watch and software system

Bolstered by an AI algorithm, the companies’ partnership is a step closer to catching up with the Apple Watch.

By Ricky Zipp • July 25, 2022

Turning your unique brand knowledge into stronger HCP relationships

How life science companies can translate their extensive brand knowledge into a digital, forward-looking HCP engagement strategy.

July 25, 2022

Johns Hopkins sepsis alert tool reduced patient deaths, studies find

Three prospective studies of a machine learning tool developed by a Johns Hopkins spinout found it led to earlier antibiotic treatment and reduced patient mortality.

By Elise Reuter • July 22, 2022

FDA patient advisers grapple with consent, oversight of virtual-reality devices in healthcare

The advisory group addressed patient consent in surgeries using augmented reality tools and how to distinguish clinical uses of virtual reality from entertainment products. 

By Elise Reuter • July 20, 2022

iRhythm says Q2 unit volumes beat forecast, names Chad Patterson as new CCO

The company noted the results are preliminary and may change before its Aug. 4 earnings call.

By Ricky Zipp • July 19, 2022

Lack of payment pathway clarity hinders digital therapeutics, analysts say

The report warns of a sector beset by payment issues, “snake oil” and “middling adoption.”

By Nick Paul Taylor • July 15, 2022

CMS proposes national rates for cardiac monitoring; iRhythm's stock jumps

The proposed rule could end a years-long saga for the cardiac market, although pricing specifics may change in the final version.

By Ricky Zipp • July 8, 2022

Semiconductor shortage leaves medtech industry 'more pessimistic' as customers leave, says Deloitte

Hospitals and health systems are looking into alternative products as a result of the disruption, according to a report from Deloitte and AdvaMed.

By Nick Paul Taylor • July 7, 2022

Wearables are a growing part of doctor-patient talks for cardiac patients: study

As mentions of wearables in primary care grew, Apple increasingly replaced Fitbit as the most-discussed wearable brand in talks between physicians and patients in the study, which covered the years 2005 to 2019. 

By Nick Paul Taylor • July 6, 2022

'Little sign' that digital tools are being deployed effectively in fight against COVID outbreak, study finds

To help reduce the spread of the next pandemic, there is “a substantial practical advantage” to integrating the features of multiple smartphone apps, a Scripps Research Translational Institute team found.

By Nick Paul Taylor • July 6, 2022

AliveCor ECG patent ruling sets stage for block on Apple Watch imports

Apple Watch imports to the U.S. could be barred if ruling by International Trade Court judge is finalized; Judge says Apple Watch infringes two cardiogram patents.

By Nick Paul Taylor • July 5, 2022