Digital Health

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

LiveMetric's blood-pressure 'smartwatch' device gets FDA clearance

The wristwatch-like device will be made available through health systems, insurers and self-insured employers to ease continuous monitoring of blood pressure and avoid white-coat syndrome.

By Nick Paul Taylor • July 1, 2022

Medtech M&A falls 85% but activity could rebound in second half: report

PwC highlights a range of barriers that could stop acquisitions, including supply chain issues, scrutiny from the Federal Trade Commission and geopolitical concerns.

By Nick Paul Taylor • June 24, 2022

As cross-state telemedicine waivers expire, virtual care advocates focus on long-term policy changes

There’s a complication: No one solution to the U.S.’ patchy physician licensing infrastructure has universal buy-in.

By Rebecca Pifer • June 22, 2022

Lack of clinical evidence 'major gap' in digital health: study

The researchers framed the low scores as evidence of “a major gap in health care technology,” adding that there is a “significant opportunity” for companies that differentiate themselves with a more rigorous approach.

By Nick Paul Taylor • June 22, 2022

Senseonics lands CE mark for 6-month CGM implant, teeing up Q3 launch in Europe

Senseonics is looking to the longer-lasting implant to re-energize its fight in a market dominated by Abbott Laboratories and Dexcom.

By Nick Paul Taylor • June 17, 2022

Apple Watch monitoring features for AFib, Parkinson's cleared by FDA

With the new feature, atrial fibrillation patients may have an easier way to track the frequency of the condition over time and see whether lifestyle changes may have positive effects.

By Nick Paul Taylor • June 14, 2022

Insulet targets competitive conversions as Omnipod 5 insulin pump nears full launch

The company said at a conference it aims to increase the rate of insulin pump use among people with Type 1 diabetes in the U.S. 

By Nick Paul Taylor • June 9, 2022

Dexcom CEO Sayer on G7 FDA submission, developing a 15-day sensor, M&A plans

Kevin Sayer spoke about the company's back-and-forth with the FDA on the G7 CGM system, possibly expanding from a 10-day to a 15-day sensor and on a report that Dexcom was in talks to buy Insulet.

By Ricky Zipp • June 7, 2022