Abbott’s FreeStyle Libre 2 CGM beats fingerstick testing in independent clinical trial

Going into the study, the researchers were unsure if CGMs with optional alarms for high and low blood glucose levels benefit patients with Type 1 diabetes.

By Nick Paul Taylor • Oct. 11, 2022

‘Inadequate’ progress of Bayer’s study on birth-control implant called out by FDA as patients drop out

The FDA saw a rise in patients dropping out of a study on the Essure birth-control implant, prompting it to tell Bayer to develop and implement strategies to ensure the work continues.

By Nick Paul Taylor • Oct. 7, 2022

Genentech, Winterlight track changes in Alzheimer’s using automated speech-based system

The researchers called the system a “promising prototype,” while cautioning that further validation is needed.

By Nick Paul Taylor • Oct. 5, 2022

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

In surprise result, Alzheimer’s drug from Eisai, Biogen shows benefit in large trial

The companies said the drug, called lecanemab, met all of its goals in the Phase 3 study. The data are a significant finding and provide stronger support for a much-debated hypothesis for treating Alzheimer’s.

By Jonathan Gardner • Updated 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

Abbott’s latest Amulet-Watchman data show more mixed results for the heart devices

The latest head-to-head trial adds to the growing rivalry between Abbott and Boston Scientific in the left atrial appendage closure space.

By Ricky Zipp • Sept. 19, 2022

Amid merger turmoil, Illumina’s Grail unit reports downturn in accuracy of blood-based cancer test

New data on Grail’s cancer screening test could weaken the company’s competitive standing against rivals Guardant Health, Exact Sciences and Freenome.

By Nick Paul Taylor • Sept. 12, 2022

Abbott heart device for newborns shows longer-term benefits with three-year data

The trial results give Abbott more evidence as it seeks to position the product as an alternative to medical management or surgical ligation.

By Nick Paul Taylor • Sept. 8, 2022

Penumbra’s catheters achieve first-pass revascularization in 68.9% of stroke patients

A separate study found the device cleared clots in patients with tandem lesions, meeting the criteria for successful restoration of blood flow in 84% of subjects.

By Nick Paul Taylor • Aug. 26, 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

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

Abbott blood test predicts death, unfavorable outcomes in traumatic brain injury patients, study finds

Abbott is pursuing FDA clearance for the breakthrough-designated TBI test to expand access to a diagnostic that predicted death and severe disability.

By Nick Paul Taylor • Aug. 12, 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

Abbott, Medtronic make case for key diabetes products in ADA presentations

Researchers at Abbott Laboratories used the event to highlight data on the FreeStyle Libre 3 continuous glucose monitor, while Medtronic arrived at the sessions with real-world results on the MiniMed 780G insulin pump.

By Nick Paul Taylor • June 6, 2022

Verily advances smartwatch toward Parkinson's clinical trial use after validating technology

The researchers concluded the wearable device could reduce the sample size needed to show the effect of a therapeutic intervention.

By Nick Paul Taylor • May 25, 2022

Moving beyond paper workflows for medical device trials

Most clinical trial solutions aren't right-sized for medical device trials. So what do sponsors do?

May 23, 2022

Edwards posts 97% success rate with tricuspid device in 30-day test as it prepares for Abbott rival

Edwards' device posted a 97% implant success rate, while Abbott's had a 98% success rate. Both are part of a growing market for transcatheter valve repair devices. 

By Nick Paul Taylor • May 20, 2022

Study shows that Abbott's Amulet, Boston Scientific's Watchman devices are riskier for women

The analysis builds on previous studies showing that left atrial appendage occlusion devices are riskier for women. However, Abbott's recent study shows comparable outcomes for men and women at 18 months.

By Nick Paul Taylor • May 19, 2022

Medtronic links renal denervation to increased time below blood-pressure threshold

Results from two studies come after the medtech company had a setback in renal denervation in October. Medtronic is expected to report results from its pivotal trial this year.

By Nick Paul Taylor • May 18, 2022

Advocacy groups support patient engagement in MDUFA V, raise concerns about device safety

Patient groups are largely supportive of the new agreement, which the FDA will finalize and send to Congress. However, some have raised concerns that the deal is too focused on industry’s interests.

By Elise Reuter • April 20, 2022

Senators drill down on rising user fees, cybersecurity and clinical trial diversity in MDUFA hearing

While Tuesday's Senate hearing did not include FDA officials, lawmakers questioned industry groups as they consider the MDUFA V agreement that would increase the amount the agency can collect in fees from device makers.

By Elise Reuter • April 6, 2022

Nearly 80% of patients with infection following cardiac implant not treated appropriately: study

A Duke University study, which was supported by Philips, showed that roughly four out of five patients with an infection following a cardiac implant did not have devices extracted, which goes against clinical guidelines.

By Ricky Zipp • April 5, 2022

Medtronic self-expanding TAVR shows durability benefit over surgery at 5 years, analysis shows

Data from from multiple trials presented at ACC's Scientific Sessions showed the rate of structural valve deterioration at five years with surgery was 4.38% versus 2.57% in patients undergoing transcatheter aortic valve replacement.

By Greg Slabodkin • April 5, 2022