Medical machine-learning studies lack high-quality clinical trials, review shows

The findings “highlight areas of concern regarding the quality of medical machine learning RCTs and suggest opportunities to improve reporting.”

By Nick Paul Taylor • Oct. 4, 2022

European AI Act could have ‘significant impact’ on manufacturers, medtech group warns

“Overregulation and misalignment” could create uncertainty and stop products from coming to market, MedTech Europe says.

By Nick Paul Taylor • Oct. 3, 2022

Explore the Trendline➔

Medical device industry continues to turn to AI

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

By MedTech Dive staff

Digital pathology gains momentum among US providers, vendors: report

Already popular in Europe, digital pathology technologies are primed for growth in the U.S., according to a report from KLAS research.

By Hailey Mensik • Sept. 30, 2022

Friday Q&A: iRhythm CEO Quentin Blackford on how the heart monitor maker plans to reach $1B in sales

Continuing the company’s success in the U.S. and expanding internationally are the two biggest factors to achieving its $1 billion forecast, says Blackford.

By Ricky Zipp • Sept. 30, 2022

Bionic pancreas led to lower blood sugar levels than standard of care: study

The results point to the potential for a simplified approach for automated insulin delivery that could be particularly useful for patients without regular access to an endocrinologist.

By Elise Reuter • Sept. 29, 2022

FDA finalizes guidance on how clinical decision support software is regulated

The FDA has overhauled the 2019 draft, deleting some sections and completely rewriting other parts of the document.

By Nick Paul Taylor • Sept. 28, 2022

FDA makes case for ‘new regulatory paradigm’ amid hurdles in software-oversight program

The agency seeks to tailor requirements based on the latest science, the benefits and risks posed by devices, their real-world performance and their contribution to promoting health equity.

By Nick Paul Taylor • Sept. 27, 2022

Forget oximeters, smartphone cameras detect 79% of cases of low blood oxygen in small study

If the results are validated by wider studies, physicians will have a new tool to increase the number of people who can be monitored for chronic and acute respiratory conditions. 

By Nick Paul Taylor • Sept. 23, 2022

Friday Q&A: Scripps’ Jay Pandit talks about wearables, decentralized trials and what’s next for digital health

As wearables confirm their ability to collect data, the big question is what to do with it all. And the next technical challenge: improving wrist-based blood pressure monitors.

By Elise Reuter • Sept. 22, 2022

Diabeloop’s insulin algorithm shows 17-point rise in time-in-range from year-long patient study

About half of the people using its device achieve the recommended outcomes, versus 27% of those using standard treatment.

By Nick Paul Taylor • Sept. 22, 2022

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

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

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

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

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