Sanofi’s Felix Lee talks DarioHealth partnership, future of digital health

The pharmaceutical company struck a strategic agreement with digital health company DarioHealth last year aimed at helping patients with diabetes manage their blood sugar levels. 

By Elise Reuter • July 21, 2023

Big Health buys Limbix to add adolescent depression app to digital therapeutic portfolio

The phone-based treatment, SparkRx, uses self-guided, cognitive behavioral therapy to teach skills such as mood tracking.

By Nick Paul Taylor • July 18, 2023

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

US trade body again delays decision on Apple-Masimo patent dispute

A potential settlement or royalty payments stemming from Masimo’s claim that Apple’s pulse oximetry features infringed on its patents could offer “significant upside” for Masimo, BTIG analysts wrote.

By Nick Paul Taylor • July 13, 2023

Masimo’s board turnover could bring Sound United spinoff, analysts say

Needham analysts say that new voices on the patient-monitoring company’s board, after a proxy battle, could catalyze the sale of the audio unit, even as Masimo pursues its consumer healthcare strategy.

By Susan Kelly • July 11, 2023

GPT-4 language model gives limited quality medical answers in study

Researchers recommended limiting the medical information used by GPT-4 to peer-reviewed studies, and adding a bibliography feature to address limitations in the answers provided by the model. 

By Nick Paul Taylor • July 5, 2023

FDA seeks feedback on technologies that can enable healthcare at home

The FDA is asking the medtech industry for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations.

By Nick Paul Taylor • June 29, 2023

Medtronic links 780G insulin pump to benefits in kids as it works to grow sales

A clinical trial found adolescent users of the pump can achieve improved blood glucose control without precisely counting carbohydrates.

By Nick Paul Taylor • June 26, 2023

Dexcom targets 25M Americans with new CGM aimed at non-insulin-using diabetics

The device will last for 15 days, include a cash-pay option and come with software designed for the needs of people who are yet to require insulin.

By Nick Paul Taylor • June 26, 2023

Bigfoot links smart insulin pen cap to improved glycemic control in real-world study

Using the system can bring “rapid and durable improvement” in glycemic control for older adults with Type 2 diabetes who use multiple daily injections, researchers found.

By Nick Paul Taylor • June 22, 2023

Owlet receives FDA clearance for prescription pulse oximetry baby sock

Clearance of the new system settles a controversy that began last year when Owl sold a similar pulse oximetry device over the counter, but was ordered to pull it from sale and seek regulatory approval as a medical device.

By Nick Paul Taylor • June 22, 2023

Analysts highlight Masimo’s advantages over Apple, Fitbit ahead of proxy vote

Even as the company faces a battle over its future direction, Stifel analysts said Masimo’s star product could “enhance patient outcomes, optimize care delivery and ‘massively’ reduce costs.”

By Nick Paul Taylor • June 20, 2023

Wrist-worn wearable could detect sickle cell pain episodes

By providing early warning of acute pain episodes caused by sickle cell disease, the device could help patients intervene earlier.

By Nick Paul Taylor • June 16, 2023

The importance of trust in AI as a medical device

Building trust with patients, as well as regulators, will be key to the adoption of AI in medical devices and diagnostics, argues Alison Dennis, a London-based partner with law firm Taylor Wessing.

By Alison Dennis • June 15, 2023

Americans’ use of healthcare wearables expanding rapidly, survey says

U.S. consumers doubled their use of wearables between 2020 and 2021, with smartwatches outpacing other devices. 

By Susan Kelly • June 14, 2023

Samsung adds heart rhythm notifications to Galaxy Watch to close gap on Apple

The news comes weeks after the FDA granted 510(k) clearance to the new feature, which can be used to detect atrial fibrillation, and positions Samsung to take on other wearable heart monitors from firms including Apple.

By Nick Paul Taylor • June 14, 2023

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

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