Digital Health: Page 15
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Insulet’s Omnipod 5 gains CE Mark for European release
After months of regulatory delays, Insulet’s newest insulin pump can now be marketed in the U.S. and European Union.
By Nick Paul Taylor • Sept. 21, 2022 -
Medtronic issues urgent notice about MiniMed insulin pump system vulnerability
Unauthorized users could hack into the device while it’s being set up, and cause the pump to deliver too much or too little insulin, potentially resulting in outcomes including death.
By Nick Paul Taylor • Sept. 21, 2022 -
Sony partners with hearing aid specialist to enter new over-the-counter market
Sony has identified the U.S. regulatory change as a chance to use its brand and audio technology to add a new growth driver to its portfolio.
By Nick Paul Taylor • Sept. 14, 2022 -
Courtesy of Press release https://verily.com/blog/verily-expands-stephen-gillett-s-role-to-president-and-chief-operating-officer/
Google sibling Verily raises $1B to invest in health data initiatives, replaces CEO
The investment strengthens Verily’s position and continues Big Tech’s push into the healthcare space.
By Nick Paul Taylor • Sept. 12, 2022 -
Machine learning algorithm predicts unfavorable labor outcomes for mothers in retrospective study
The researchers plan to validate the model using Mayo Clinic patients before deploying it prospectively in maternity wards.
By Nick Paul Taylor • Sept. 6, 2022 -
Q&A
Friday Q&A: iRhythm CTO Mark Day talks Zio Watch, Verily partnership, Big Tech in healthcare
Day spoke about developing a smartwatch for cardiac monitoring with Alphabet’s Verily, competing with Apple and building clinical evidence for the new product.
By Ricky Zipp • Sept. 2, 2022 -
Medtronic grows patient monitoring offerings with BioIntelliSense partnership
Wearable patient monitors can help with healthcare staffing shortages, an ongoing challenge for hospitals, and create an opportunity for device makers.
By Ricky Zipp • Sept. 1, 2022 -
Q&A
Akili CEO Martucci sees ‘massive’ need for company’s ADHD video-game treatment
With enough cash now to last two years, the company hopes it can change the way children with ADHD are treated, offering an alternative to pharmaceuticals.
By Elise Reuter • Aug. 29, 2022 -
Sponsored by Esper
The future of healthcare technology is remote patient monitoring — here’s what you need to know
Organizations leading the charge in remote monitoring innovation are setting themselves up for long-term success.
Aug. 29, 2022 -
Review finds ‘paucity of robust evidence’ on impact of AI clinical outcomes
Of the nearly 12,000 articles on artificial intelligence, only 39 described randomized controlled trials, making it difficult to quantify the clinical benefits of using AI-assisted tools for patient care.
By Nick Paul Taylor • Aug. 26, 2022 -
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 -
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 -
Q&A
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