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

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

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

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

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

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

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

BioIntelliSense buys AlertWatch, expanding Medtronic patient monitoring partnership

Medtronic will distribute AlertWatch to hospitals in the U.S. alongside BioIntelliSense’s wearable device for continuous remote monitoring.

By Nick Paul Taylor • Oct. 25, 2022

FDA moves to make effect on health equity part of breakthrough device considerations

If it finalizes the proposal, the agency will expand its breakthrough program to devices that improve accessibility.

By Nick Paul Taylor • Oct. 21, 2022

GE forms pact with AMC Health to enable more remote monitoring in home care

As costs of caring for chronic disease rise and hospital staffing remains a challenge, home care remotely monitored by clinicians is emerging as a cost-saving frontier.

By Nick Paul Taylor • Oct. 20, 2022

FDA seeks feedback on plans to draft and finalize medical device guidance in 2023

The agency’s review includes guidance on transitioning away from emergency use authorizations, while abandoning plans for guidance on software as a medical device.

By Nick Paul Taylor • Oct. 19, 2022

Lucid enters OTC hearing aid market, undercutting rivals with devices starting at $200

Lucid joins Sony and the Bose-partnered Lexie Hearing with aids priced thousands of dollars below prescription devices, putting auditory assistance within reach of tens of millions of Americans. 

By Nick Paul Taylor • Oct. 18, 2022

Why Android is the future of connected HealthTech devices

How Android can make your connected HealthTech device strategy a success.

Oct. 17, 2022

Bose-partnered Lexie to launch $999 OTC hearing aid, challenging Sony, Eargo in nascent market

Lexie has matched the price of the first Sony device and is seeking to differentiate itself through the use of a rechargeable battery.

By Nick Paul Taylor • Oct. 14, 2022

AI matches humans at detecting mental health red flags in text messages, study shows

The study suggests algorithms have the potential to enable automated tools for clinical support of people with mental illness.

By Nick Paul Taylor • Oct. 13, 2022

‘Do-it-yourself’ artificial pancreas system beats production-line pump in controlled trial

Type 1 diabetes patients who used a customizable, open-source artificial pancreas, an insulin pump and a Dexcom G6 CGM found it more effective at controlling blood glucose than conventional sensor-augmented insulin pumps.

By Nick Paul Taylor • Oct. 12, 2022

Software to predict risk of sepsis, stroke should be regulated as a medical device, says FDA

Clarity on rules welcomed by some device makers, who also cautioned that products may take longer to come to market. 

By Elise Reuter • Oct. 11, 2022

Abbott’s FreeStyle Libre 2 CGM beats fingerstick testing in independent clinical trial

Going into the study, the researchers were unsure if CGMs with optional alarms for high and low blood glucose levels benefit patients with Type 1 diabetes.

By Nick Paul Taylor • Oct. 11, 2022

4 proven participant education techniques to improve electronic collection of informed consent

Patient education is vital to informed consent. Improve your approach with these best practices.

By Nicole Latimer, Chief Executive Officer • Oct. 10, 2022

NovaSight’s digital treatment for lazy eye gets FDA nod, providing alternative to patching

A randomized controlled trial found the digital device to be as effective as wearing an eye patch, the current gold standard for treatment, opening the way for more children to complete necessary therapy for amblyopia.

By Nick Paul Taylor • Oct. 10, 2022

Owlet seeks clearance of blood-oxygen-measuring baby sock after FDA warning letter

Owlet now is a step closer to selling a prescription medical device designed to alert parents when their baby’s heart rate or oxygen saturation levels move outside of prescribed ranges. 

By Nick Paul Taylor • Oct. 10, 2022

Friday Q&A: Paige CEO Andy Moye on how digital pathology is changing the diagnostic game

Commercial laboratories and academic medical centers are starting to adopt digital tools to help pathologists detect cancer, opening a large market for AI-powered diagnostic tools.

By Elise Reuter • Updated Oct. 8, 2022

Dexcom, Abbott have ‘massive opportunity’ with new CGM coverage proposal: analysts

Analysts at J.P. Morgan said the proposal reads “very favorably” for the two leading makers of continuous glucose monitors and unlocks “a major near-term driver for growth.”

By Nick Paul Taylor • Oct. 7, 2022

Dexcom starts global rollout of G7 CGM system, launching device in U.K. and Germany

Software updates have delayed the introduction of the product in the U.S. at a time when the company seeks to take market share from rival Abbott.

By Nick Paul Taylor • Oct. 6, 2022

Genentech, Winterlight track changes in Alzheimer’s using automated speech-based system

The researchers called the system a “promising prototype,” while cautioning that further validation is needed.

By Nick Paul Taylor • Oct. 5, 2022

Digital health funding collapsed in Q3, falling to lowest level since 2019: analysts

Analysts at Rock Health said “the market isn’t the same as it was” after seeing a sharp drop in late-stage deals.

By Nick Paul Taylor • Oct. 5, 2022