FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech

The head of the agency said the models are “ushering in the revolution that many of us were hoping for,” but cautioned that the sector will need to be regulated appropriately.

By Nick Paul Taylor • May 9, 2023

Algorithm may help avoid 40% of kidney transplant rejection misdiagnoses: study

The decision-support system “could have important clinical implications for the management and treatment of transplant recipients,” researchers found.

By Nick Paul Taylor • May 5, 2023

FDA posts draft guidance on studying medical devices in decentralized clinical trials

Analysts at Cowen said the draft could reassure sponsors they can run decentralized trials without complicating approvals.

By Nick Paul Taylor • May 4, 2023

J&J study data show dramatic benefit to multiple myeloma cell therapy

A study abstract inadvertently posted online showed J&J and Legend’s therapy, Carvykti, reduced the risk of disease progression or death by more than 70% over standard drugs.

By Ned Pagliarulo • April 19, 2023

AFib study shows no effect on outcomes from 1-year delay of catheter ablation

Early treatment could be a boon for medtech companies such as Boston Scientific and Medtronic but is potentially challenging for healthcare systems. The new study suggests waits of up to a year will not harm patients.

By Nick Paul Taylor • April 19, 2023

OTC hearing aid matches performance of audiologist-fitted device in small trial

People who used an over-the-counter hearing aid for six weeks saw similar results to people who used an audiologist-fitted device, suggesting less costly, self-fitted hearing aids could be an option. 

By Nick Paul Taylor • April 13, 2023

Implantable heart failure sensors cut death risk in study: Abbott

Philip Adamson, chief medical officer for Abbott’s heart failure business, called the finding “profound.”

By Susan Kelly • March 27, 2023

Tandem, targeting Medtronic and Insulet’s turf, links artificial pancreas to improved outcomes in kids

If Tandem can prove to regulators that the system can help manage young children’s diabetes, it could compete with Medtronic and Insulet, which have devices that are indicated for use in kids as young as two years.

By Nick Paul Taylor • March 16, 2023

Medtronic’s pulsed field ablation device meets safety, efficacy metrics in trial

Medtronic’s device didn’t outperform competing systems being developed by J&J and Boston Scientific, but the results should be enough to secure FDA approval, one analyst wrote.

By Elise Reuter • March 7, 2023

Medtronic TAVR data in healthier patients fuels battle with Edwards for heart valve market share

The results show that low-risk aortic stenosis patients have better outcomes after three years when catheters are used to insert their replacement heart valves, rather than traditional open-heart surgery.

By Nick Paul Taylor • March 7, 2023

Abbott’s TriClip improves tricuspid regurgitation in pivotal trial ahead of showdown with Edwards

The transcatheter repair clip beat the established medical therapy on the primary composite endpoint, setting up a battle with rival Edwards for a $5 billion market.

By Nick Paul Taylor • March 6, 2023

Phone app tracks cough frequency in tuberculosis trial, opening up monitoring opportunity

If validated in further studies, the work could further expand the use of smartphones as diagnostic tools, particularly in areas where there are few medical professionals, and could help stop overtreatment of TB.

By Nick Paul Taylor • March 6, 2023

Elon Musk’s bid to study brain implant in humans rejected by FDA on safety grounds: report

The FDA reportedly raised concerns about the device’s lithium battery, the potential for its wires to migrate across the brain, and how it would be removed.

By Nick Paul Taylor • March 3, 2023

ReCor follows Medtronic in making case for renal denervation as FDA mulls approval decision

An analysis of three clinical trials linked the intervention to consistent reductions in blood pressure.

By Nick Paul Taylor • March 1, 2023

Medtronic links MiniMed 780G automated insulin delivery to sustained glucose control benefits

The data indicates patients should receive automated insulin delivery earlier, rather than starting treatment with multiple daily injections, Medtronic said.

By Nick Paul Taylor • Feb. 27, 2023

Spinal cord stimulation shows ability to improve motor function in stroke patients in small trial

The spinal implant improved strength, grip force and movement, enabling participants to recover the use of limbs incapacitated by stroke.

By Nick Paul Taylor • Feb. 21, 2023

J&J, Medtronic, Boston Scientific gird for battle over US cardiac ablation market with new trials

Medtech firms are sharing clinical trial results on pulse ablation devices, which they claim are safer and more effective at halting arrhythmias than current methods.

By Elise Reuter • Feb. 8, 2023

CT scans offer new path to diagnose treatable cause of high blood pressure, study shows

While the approach could increase demand for CT imaging, the supply of radioactive tracers is potentially a barrier to adoption of the technique.

By Nick Paul Taylor • Jan. 19, 2023

AI predicts lung cancer risk six years into the future using single CT scan: study

A research team has made the deep learning model publicly available and says it has no intention to commercialize it.

By Nick Paul Taylor • Jan. 17, 2023

Labcorp hires ex-Quintiles CEO to lead clinical development unit ahead of upcoming spinoff

Thomas Pike, who oversaw the transformational merger of Quintiles and IMS Health, will be in charge of a CRO for the first time since 2016.

By Nick Paul Taylor • Jan. 6, 2023

AstraZeneca extends C2i pact to validate minimal residual disease solid tumor blood test

The technology could improve cancer treatment and support clinical trial recruitment and monitoring.

By Nick Paul Taylor • Jan. 6, 2023

Novocure shares jump on positive lung cancer data

A regimen involving the Swiss biotech’s electrical field-based treatment extended lives in a late-stage trial. But data comparing the medical device to standard chemotherapy is less persuasive.

By Jonathan Gardner • Jan. 5, 2023

Freenome CEO Mike Nolan talks colorectal cancer test, clinical trials

The San Francisco-based company recently enrolled a clinical trial for its blood-based cancer test but faces competition in the market for minimally invasive cancer tests. 

By Elise Reuter • Dec. 22, 2022

Medtronic starts US robotic surgery trial in push to challenge Intuitive

Medtronic delayed the Hugo program to make changes in light of surgeon feedback, but now plans to evaluate the use of the surgical robot in urologic procedures, facing off against competitor Intuitive. 

By Nick Paul Taylor • Dec. 20, 2022

MDR costs are driving manufacturers to pull products from European market: report

The report adds to evidence that makers of products used for pediatric patients and rare diseases have been particularly hard hit.

By Nick Paul Taylor • Dec. 20, 2022