Penumbra expands VR rehabilitation platform with lower body sensors

Adding lower body sensors will enable the company to target a wider range of health conditions.

By Nick Paul Taylor • Nov. 16, 2022

Pear Therapeutics undergoes another round of layoffs, cutting 22% of staff

The digital therapeutics company said the reductions will extend its cash runway and curb its reliance on financing.

By Elise Reuter • Nov. 15, 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

NFL expands program to use sensor-loaded mouthguards to gather head impact data

Data from the sensors could show what the human head experiences during an impact, improving efforts to reduce the incidence of concussions in football.

By Nick Paul Taylor • Nov. 15, 2022

ResMed, Google sibling Verily form digital health venture to improve access to sleep treatment

Primasun will use an app to diagnose and treat obstructive sleep apnea and evaluate patients with insomnia symptoms.

By Nick Paul Taylor • Nov. 15, 2022

Tandem pump, paired with Dexcom CGM, boosts blood glucose control in Type 2 diabetics

Patients with Type 2 diabetes spent 3.6 hours per day longer in the target blood glucose range after switching to Tandem’s system, a study found.

By Nick Paul Taylor • Nov. 14, 2022

Mayo Clinic creates product to test AI models for bias and inaccuracy

The proliferation of AI models has led to concerns about whether they work as intended. 

By Nick Paul Taylor • Nov. 14, 2022

Friday Q&A: GE HealthCare’s Shetty on building accurate AI tools

The executive, who leads the company’s effort to create an integrated suite of AI tools for hospitals, warns against overloading clinicians with unconnected information.

By Elise Reuter • Nov. 11, 2022

Medtech execs ‘rethink’ long-term strategies as care settings shift: Accenture report

The move from hospitals to ambulatory and at-home care is only just beginning, the survey found.

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

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

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