Medtronic misses primary endpoint in renal denervation study

The device didn't outperform drug therapy when patients measured their blood pressure at home, though it's still expected to win FDA approval.

By Elise Reuter • Nov. 8, 2022

Verily’s Onduo cut blood sugar in retrospective study of Type 2 diabetics

Participants with high blood sugar at baseline benefited the most from Onduo, a study found.

By Nick Paul Taylor • Nov. 8, 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

Power play: How harvesting energy from lungs may end need to replace batteries in brain stimulators

Researchers, aiming to prolong the life of powered devices that stimulate vital organs, are looking to bio-mechanics while also reducing the need for regular surgery to change batteries.

By Nick Paul Taylor • Nov. 8, 2022

Medtronic’s AFib ablation device beats antiarrhythmic drugs in 3-year study

Arctic Front cryoablation devices show promise as an early treatment for atrial fibrillation.

By Nick Paul Taylor • Nov. 8, 2022

iRhythm analysis shows savings from patients wearing Zio XT cardiac monitor patch

Scientists who performed the study say using the patch will save healthcare systems money by enabling early diagnosis.

By Peter Green • Nov. 7, 2022

5 takeaways from the FDA’s list of AI-enabled medical devices

As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates.

By Elise Reuter • Nov. 7, 2022

Insulet reports record number of new customers on Omnipod 5 launch; shares climb

The company had the highest U.S. Omnipod revenue growth in a decade and also unveiled a new basal-insulin only pump.

By Elise Reuter • Nov. 4, 2022

Friday Q&A: FemTech Focus’s Barreto discusses women’s health innovations, funding challenges

The executive director of the nonprofit group explains why women's health is finally getting attention and what the FemTech revolution is all about.

By Susan Kelly • Nov. 4, 2022

Teleflex recall of respiratory filters labeled Class I by FDA

The filters may split or detach from hospital respirators, disrupting airflow to patients and potentially causing death, the agency says.

By Peter Green • Nov. 4, 2022

Q&A: Nuheara CEO talks about market potential for OTC hearing aids

John Luna discusses how the FDA’s new category of medical-quality, non-prescription hearing aids is poised to change the market.

By Peter Green • Nov. 3, 2022

Zimmer Q3 profit advances on higher sales of hip, knee joints

Analysts say the firm is grabbing market share, positioning it to recover income lost due to the pandemic-driven decline in elective procedures.

By Peter Green • Nov. 3, 2022

iRhythm narrowed loss in Q3 on higher sales of cardiac wearables

Revised CMS reimbursement rates may boost the earnings potential for the company’s wearable heart monitors.

By Peter Green • Updated Nov. 4, 2022

BioIntelliSense adds skin-color sensitivity to pulse oximeter chips amid FDA concerns over fingertip devices

An IT-driven blood-oxygen meter may help reduce a racial disparity in care caused by erroneous readings.

By Peter Green • Updated Nov. 2, 2022

J&J to buy heart device maker Abiomed for $16.6B in year’s largest medtech deal

J&J will gain Abiomed’s heart pump devices amid a booming cardiac care market.

By Elise Reuter • Updated Nov. 2, 2022

OTC hearing aid maker Nuheara gets 510(k) clearance for HP-branded device, undercuts Lexie, Sony on price

Nuheara is betting that the combination of its technology and the HP brand will enable its product to claim a slice of the market.

By Nick Paul Taylor • Nov. 1, 2022

Hologic quarterly sales beat forecast even as demand for COVID tests wanes

The company expects its surgical and breast health businesses to rebound in fiscal 2023.

By Nick Paul Taylor • Nov. 1, 2022

Stryker sales growth limited by hospital staffing, ‘soft’ installations of Mako robot

Mako installations were “soft” because of “delays stemming from variability in the hospital environment.”

By Nick Paul Taylor • Nov. 1, 2022

Brain surgery may get boost from new steerable catheter using minimally invasive robot

The steerable needle could help surgeons more accurately reach the deep, delicate parts of the brain than existing rigid catheter technologies.

By Nick Paul Taylor • Oct. 31, 2022

Researchers develop light-based sensor to overcome diagnostic limitations of electrodes

The technology could enable “ultra-miniature” interfaces for heart and nerve devices both in clinical diagnostics and laboratory research.

By Nick Paul Taylor • Oct. 31, 2022

FDA breakthrough device designations fall in Q3 but record year still within reach

If activity accelerates after the summer months, the agency will post another record year for designations.

By Nick Paul Taylor • Oct. 31, 2022

Dexcom Q3 profit surges as CGM maker prepares for G7 launch in U.S.

Dexcom has a “compelling series of catalysts” over the next year that can accelerate growth, analysts say. 

By Elise Reuter • Oct. 28, 2022

Edwards says it expects sales to stall in Q4 as hospital staff shortages stymie TAVR growth

The company has heard reports it may take hospitals “up to a year or two” to resolve the staffing situation.

By Nick Paul Taylor • Oct. 28, 2022

ResMed quarterly profit rises on AirSense sales; CEO skeptical about timeline of Philips’ return to market

CEO Mick Farrell says he’s “not optimistic” rival Philips will be back on the market in January “given all the issues that are there for them.”

By Nick Paul Taylor • Oct. 28, 2022

Baxter lowers 2022 earnings forecast, citing supply chain, foreign-exchange pressures

The company took a $3.1 billion impairment charge in the third quarter related to its acquisition of connected care firm Hillrom in December 2021.

By Elise Reuter • Oct. 27, 2022

Baxter warns hospitals to stop using connected incontinence pads over interference risk

The interference may affect insulin pumps, fetal monitors, telemetry devices, bladder scanners and infusion pumps.

By Nick Paul Taylor • Oct. 27, 2022