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

Abbott study shows benefits of OCT imaging in stent placement

Optical coherence tomography improved doctors’ ability to place stents, but the study did not meet its primary goal for reducing a composite of deaths, heart attacks and repeat procedures. 

By Susan Kelly • Aug. 31, 2023

Boston Scientific’s pulsed field ablation device matches standard of care in AFib trial

RBC analysts forecast “conversion of 80% to 90% of the market over a 2-3 year period” after seeing the Farapulse data.

By Nick Paul Taylor • Aug. 28, 2023

Edwards software linked to improved blood pressure control during surgery

Results of a registry analysis suggest “software monitoring may help reduce the duration and severity of intraoperative hypotension.”

By Nick Paul Taylor • Aug. 17, 2023

Boston Scientific’s pivotal pulsed field ablation trial expected to succeed: analysts

Positive results could position Boston Scientific to win U.S. approval for Farapulse in the second half of next year.

By Nick Paul Taylor • Aug. 14, 2023

Device volumes to hold up against threat of Wegovy, other GLP-1 drugs: analysts

Issues such as “nontrivial side effects, cost concerns and patient persistence” will mean physicians continue to use medical devices, analysts say.

By Nick Paul Taylor • Aug. 9, 2023

Penumbra says stroke device delayed at least 12 months due to FDA request

The setback stalls “a meaningful new product catalyst,” but the growth of Penumbra’s other devices could cushion the impact, analysts said.

By Nick Paul Taylor • Aug. 4, 2023

AI reduces radiologist workload in mammography clinical trial but expert urges caution

The trial linked the AI-supported screen-reading procedure, ScreenPoint Medical’s Transpara, to a 44% reduction in radiologist workload.

By Nick Paul Taylor • Aug. 2, 2023

FDA shares draft guidance on studying medtech treatments for opioid use disorder

The FDA aims to address challenges including inaccurate self-reported drug use, missing data and the need to show the durability of the treatment.

By Nick Paul Taylor • July 28, 2023

Hearing aids fail to improve cognition in randomized trial, but subgroup analysis offers hope

While there were no positive effects observed in healthy older adults, a smaller analysis pointed to a difference in those at higher risk of cognitive decline.

By Nick Paul Taylor • July 18, 2023

FDA seeks feedback on technologies that can enable healthcare at home

The FDA is asking the medtech industry for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations.

By Nick Paul Taylor • June 29, 2023

Medtronic links 780G insulin pump to benefits in kids as it works to grow sales

A clinical trial found adolescent users of the pump can achieve improved blood glucose control without precisely counting carbohydrates.

By Nick Paul Taylor • June 26, 2023

Bigfoot links smart insulin pen cap to improved glycemic control in real-world study

Using the system can bring “rapid and durable improvement” in glycemic control for older adults with Type 2 diabetes who use multiple daily injections, researchers found.

By Nick Paul Taylor • June 22, 2023

Exact Sciences’ next-gen colorectal cancer test hits primary goals in pivotal study

The analysis suggests the new stool-based test provides more true positives and fewer false positives than its predecessor.

By Nick Paul Taylor • June 21, 2023

Precision Neuroscience’s brain implant maps electrical activity in a first-in-human trial

Created by a founder of Elon Musk’s Neuralink, Precision has developed a device with some 1,000 electrodes in a one square centimeter flexible film. The trial could open the way to a computer-brain interface.

By Nick Paul Taylor • June 8, 2023

Cue Health wins first non-emergency authorization for COVID test, days after Goldman downgrade

The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms.

By Peter Green • June 7, 2023

Abbott’s remote heart failure monitoring system reduces hospitalizations in clinical trial

The study is the third randomized, controlled trial globally to link CardioMEMS to a significant health benefit.

By Nick Paul Taylor • May 26, 2023

PulseAI algorithm beats Apple Watch software at detecting atrial arrhythmias

In a head-to-head comparison with Apple’s pre-installed software for interpreting ECG data, Pulse AI’s algorithm was better at detecting atrial arrhythmias. 

By Nick Paul Taylor • May 23, 2023

Abbott, Boston Scientific, Medtronic share data on heart rhythm devices at conference

A series of recent innovations in pacemaker technology has opened up new markets and set the stage for increased competition.

By Nick Paul Taylor • May 22, 2023

Chinese medtechs post data on renal denervation devices to rival Medtronic, ReCor

The findings validate the technique used by Medtronic and ReCor, while suggesting the U.S. companies will face competition if they target the Chinese market.

By Nick Paul Taylor • May 19, 2023

Abbott shares data showing benefit of TriClip device amid FDA review

Patients experienced a reduction in tricuspid regurgitation and had improved heart function, according to late-breaking data presented at EuroPCR.

By Elise Reuter • May 18, 2023

Clinical trials showcase potential roles for ultrasound in treating cancer, inflammatory disease

The use of ultrasound as a therapeutic device could lead to new treatment options. In one study, patients with brain tumors received an ultrasound implant that allowed a drug to enter the brain.

By Nick Paul Taylor • May 18, 2023

Diabetes app developers must generate more data on clinical effectiveness, study says

The researchers saw a need for more data on the wider clinical effectiveness of apps in the management of Type 1 diabetes and prediabetes.

By Nick Paul Taylor • May 16, 2023

Guardant blood test detects 83% of colorectal cancer cases, but fewer in early stage

Analysts said the test is likely to meet the bar for FDA approval, but its flaws in detecting early-stage cancer weaken its chances against Exact Sciences’ stool-based test, Cologuard.

By Elise Reuter • May 10, 2023