Huma hails 510(k) clearance as boost to digital health product development

The clearance permits Huma to host digital health tools from multiple creators that support screening, diagnosis, dosing recommendations and clinical decisions.

By Nick Paul Taylor • June 13, 2023

Low-cost, disposable ‘pencil-on-paper’ sensor opens population health opportunities

Designed by the research team that developed the smart diaper, the paper patch could be used to detect cardiopulmonary disease and treat inflammation, or monitor disease outbreaks.

By Nick Paul Taylor • June 7, 2023

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

Masimo pushes back against activist investor it argues will cause ‘dysfunction and chaos’

Launching a proxy battle for two board seats, Politan Capital says Masimo is underperforming its peers and making misleading public statements.

By Nick Paul Taylor • June 1, 2023

MedTech Europe sets out position on cybersecurity, making case for reliance on MDR

As the number of connected medical devices grows, the industry group argues that Europe’s new medtech regulations should remain “the primary avenue” for medical device cybersecurity.

By Nick Paul Taylor • Updated June 12, 2023

Slump in medtech VC activity continues as inflation keeps investors on the sidelines

Investors struck deals worth $1.8 billion over the first three months of the year, down from $3.0 billion across the start of 2022.

By Nick Paul Taylor • May 25, 2023

Acurable prepares to challenge ResMed for sleep apnea diagnosis market

The company’s device records the sounds of the patient’s respiratory and cardiac functions and monitors blood oxygen levels to assess suspected obstructive sleep apnea.

By Nick Paul Taylor • May 25, 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

FTC moves to strengthen Health Breach Notification Rule’s applicability to digital health apps

Regulators are increasingly leaning on the HBNR to crack down on the sharing of sensitive medical data, and the FTC is looking to strengthen its case.

By Rebecca Pifer • May 18, 2023

Rapid AI adoption could cause medical errors, patient harm, WHO warns, urging oversight

Warning that caution is not being exercised with use of artificial intelligence in healthcare, the World Health Organization called for rigorous oversight of the new technology.

By Susan Kelly • May 17, 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

Google adds image analysis capabilities to generative AI model, enabling dialogues with doctors

The Med-PaLM 2 has the ability to review X-rays and mammograms, write reports about images and respond to follow-up questions from caregivers.

By Nick Paul Taylor • May 11, 2023

Samsung gets FDA clearance for irregular heart notification feature, catching up with Apple and Fitbit

The addition lets Samsung compete with Apple and Fitbit, which can also passively monitor for signs of atrial fibrillation.

By Elise Reuter • May 9, 2023

FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech

The head of the agency said the models are “ushering in the revolution that many of us were hoping for,” but cautioned that the sector will need to be regulated appropriately.

By Nick Paul Taylor • May 9, 2023

iRhythm says it received DOJ subpoena regarding company’s ‘products and services’

The company’s shares fell more than 5% after the federal government requested documents.

By Nick Paul Taylor • May 5, 2023

Algorithm may help avoid 40% of kidney transplant rejection misdiagnoses: study

The decision-support system “could have important clinical implications for the management and treatment of transplant recipients,” researchers found.

By Nick Paul Taylor • May 5, 2023

Akili shares rise after early data shows video game treatment can improve attention in adults

The company aims to expand its video game-based treatment for ADHD to adults and adolescents. 

By Elise Reuter • May 4, 2023

Masimo suit against Apple over smartwatch trade secrets ends in mistrial

The medical device maker said it intends to retry the lawsuit, as it awaits a decision from the International Trade Commission on a separate investigation into patent infringement claims against Apple.

By Susan Kelly • May 2, 2023

Amazon closes Halo health tracking unit as wave of tech layoffs continues

As it eliminates 27,000 jobs this year, the tech giant is exiting the wearables sector, and its Halo devices will stop working on Aug. 1.

By Nick Paul Taylor • May 1, 2023

Friday Q&A: J&J’s Shan Jegatheeswaran talks about the ‘behind the scenes’ work of AI in medtech

The global head of digital solutions for J&J’s medtech unit says the intersection between software and how it’s used is an important, and often overlooked, aspect of AI.

By Elise Reuter • April 28, 2023

Know Labs hopes to advance non-invasive glucose sensor with proof-of-concept test

The company wants to use its Bio-RFID technology for glucose monitoring, and recently showed the device could detect and quantify specific molecules in water. 

By Nick Paul Taylor • April 25, 2023

Report names connected medical devices with the biggest cybersecurity risks

The findings come as medical device makers face upcoming FDA requirements for providing cybersecurity information as part of their pre-market submissions.

By Nick Paul Taylor • April 21, 2023

What medtech startups need to know about remote monitoring

Four medtech executives talked about the future of hospital at home, and the difference between consumer devices and medical devices, in an event hosted by the Colorado Bioscience Association.

By Elise Reuter • April 17, 2023

iCAD, in midst of restructuring, names three new top executives

The mammography AI company last month said it would lay off 28% of its staff to save money.

By Susan Kelly • April 17, 2023

Friday Q&A: Medtronic’s Ajizian talks connected care ahead of unit spinoff

From supporting AI-driven medical interventions to freeing up providers from administrative tasks, remote patient monitoring is raising the bar for care, says Medtronic’s CMO for patient monitoring.

By Susan Kelly • April 15, 2023

OTC hearing aid matches performance of audiologist-fitted device in small trial

People who used an over-the-counter hearing aid for six weeks saw similar results to people who used an audiologist-fitted device, suggesting less costly, self-fitted hearing aids could be an option. 

By Nick Paul Taylor • April 13, 2023