Medical Devices: Page 59
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J&J names Tezel global head of medtech R&D as Shen retires
The executive will take up the post as the company says it’s looking to innovation for future profits.
By Nick Paul Taylor • Nov. 10, 2022 -
Affordable alternative: Smartphone-based hearing test for infants targets developing countries
The off-the-shelf alternative has a material cost of $10, giving children in impoverished regions easier access to vital monitoring and diagnosis.
By Nick Paul Taylor • Nov. 9, 2022 -
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 -
Lilly’s new diabetes management platform to integrate Dexcom CGM
The launch comes seven years after the company began investing in device R&D to counter pricing pressures.
By Nick Paul Taylor • Nov. 9, 2022 -
Siemens Healthineers beats sales forecasts on imaging demand as diagnostic pressures prompt restructuring
Siemens Healthineers is revamping its diagnostics unit after concluding that “external headwinds [are] outweighing operational improvements.”
By Nick Paul Taylor • Nov. 9, 2022 -
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 -
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 -
Q&A
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
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