Freenome starts 20,000-subject study of lung cancer blood test

The privately held company claims its test could offer an alternative to CT imaging, which exposes people to radiation.

By Nick Paul Taylor • Dec. 14, 2023

‘No tolerance for failure’: An oral history of the first CRISPR medicine

A new sickle cell disease therapy developed by CRISPR Therapeutics and Vertex Pharmaceuticals is now approved in the U.S. and U.K. This is the story of how it came to be.

By Ned Pagliarulo , Shaun Lucas • Dec. 13, 2023

Empatica aims to develop seizure-forecasting algorithm based on wearable data

The company plans a study using its wrist-worn device to capture real-world data that could help understand and predict seizures for people with epilepsy.

By Nick Paul Taylor • Dec. 1, 2023

AstraZeneca creates digital health unit, with big-name partnerships already in place

Called Evinova, the unit will operate as a separate business within AstraZeneca, which sees digital health solutions as a market primed for growth.

By Jacob Bell • Nov. 20, 2023

Abbott study links aspirin-free regimen to better outcomes in heart pump patients

An accompanying editorial said the “data provide an opportunity to immediately improve the outcomes of patients implanted with contemporary LVADs.”

By Nick Paul Taylor • Nov. 15, 2023

Large registry study upholds safety findings for Boston Scientific’s Farapulse device

The results, presented at the American Heart Association Scientific Sessions, showed a low rate of adverse events for the pulsed-field ablation treatment.

By Elise Reuter • Nov. 14, 2023

Biden initiative aims to accelerate women’s health research

AdvaMed endorsed the White House effort, stressing the need for equitable development and funding of new technologies.

By Susan Kelly • Nov. 14, 2023

Wegovy study details revive debate over GLP-1 impact on devices

The data confirmed a cardiovascular benefit for heart patients and showed the drug could help pre-diabetic patients control their blood sugar.

By Susan Kelly • Nov. 13, 2023

J&J links radiofrequency catheter to improved quality of life in atrial fibrillation study

Scores on a quality-of-life scale improved and use of antiarrhythmic drugs fell after people underwent treatment with the device.

By Nick Paul Taylor • Nov. 6, 2023

Penumbra touts benefits of vacuum thrombectomy for PE in late-breaking data

An interim analysis of Penumbra’s Indigo aspiration system met its primary safety and efficacy criteria, according to data shared at the Vascular Interventional Advances Conference.

By Elise Reuter • Nov. 3, 2023

Edwards posts early look at tricuspid device, stoking Abbott rivalry ahead of FDA panel

Nearly 94% of patients had their condition improve to mild or no tricuspid regurgitation six months after treatment, according to the study.

By Nick Paul Taylor • Oct. 27, 2023

Abbott’s resorbable scaffold improves outcomes in below-the-knee artery disease, study finds

The device maker plans to submit the Esprit BTK data to the Food and Drug Administration for review.

By Nick Paul Taylor • Oct. 26, 2023

Boston Scientific study results support coronary drug-coated balloon in US

The results, shared at TCT 2023, found the company’s drug-coated balloon performed better than an uncoated balloon in procedures to reopen blocked arteries.

By Elise Reuter • Oct. 25, 2023

Edwards, Medtronic post low-risk TAVR data, allaying fears of market disruption

The late-breaking results, shared at TCT 2023, will have little impact on clinical practice or market share, J.P. Morgan and Stifel analysts predicted.

By Nick Paul Taylor • Oct. 25, 2023

Physicians forecast Edwards’ 5-year data will have limited impact on low-risk TAVR market

Some doctors think TAVR may perform numerically worse but see little impact on the market unless there is a statistically significant result.

By Nick Paul Taylor • Oct. 20, 2023

Duke researchers find app improves autism screening in NIH-funded study

Participants who screened positive for autism had a nearly 41% probability of being diagnosed with the condition.

By Nick Paul Taylor • Oct. 4, 2023

Harbinger Health raises $140M to study blood-based cancer screening test

The test developer will use the series B funding to complete a 10,000-subject clinical trial ahead of a planned launch in 2025.

By Nick Paul Taylor • Sept. 28, 2023

Clinical data from Boston Scientific and rivals could reshape pulmonary embolism market: analysts

It is not yet clear how different approaches would benefit specific patients, creating uncertainty about which businesses will profit from the shift.

By Nick Paul Taylor • Sept. 26, 2023

J&J starts trial of pulsed field ablation catheter with mapping feedback

Omnypulse expands J&J’s portfolio of investigational devices with a catheter that gathers contact force data.

By Nick Paul Taylor • Sept. 19, 2023

FDA releases draft guidance for studying weight loss devices

The documents arrive amid questions about whether new medicines will cut demand for weight loss procedures.

By Nick Paul Taylor • Sept. 19, 2023

Beacon Biosignals receives FDA clearance for sleep tracking headband

The company’s at-home device, the Dreem 3S, has six EEG electrodes to capture brain activity.

By Nick Paul Taylor • Sept. 18, 2023

FDA finalizes combination product guidance 7 years after sharing draft

AdvaMed called overlapping human factor requirements of the draft guidance “overly burdensome.”

By Nick Paul Taylor • Sept. 13, 2023

FDA proposes 3 guidances to improve 510(k) clearance process

The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.

By Nick Paul Taylor • Sept. 7, 2023

Synchron brain-computer interface implanted in first 6 US patients

The device is intended to give people with severe paralysis the ability to use their thoughts to perform everyday functions, such as online communications, hands-free.

By Susan Kelly • Sept. 6, 2023

Guardant abandons cancer blood test trial early, restates confidence in product line

Guardant stopped enrolling new patients in the study because of its design and use of an older generation test, analysts said.

By Nick Paul Taylor • Sept. 6, 2023