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Aug. 14, 2023

Q&A: ‘Chaotic’ digital health market needs independent evaluation, new institute says

Independent evaluation could help the healthcare industry figure out which digital health products are backed by evidence, argues Caroline Pearson, executive director of the nonprofit Peterson Center on Healthcare.

By Emily Olsen • Aug. 11, 2023

Stryker touts Mako robot in DTC ads, as device makers eye broader patient populations

The company is taking its message on the benefits of robotic orthopedic surgery directly to patients at a time when analysts say medtech firms are targeting a wider audience through advertising.

By Susan Kelly • Aug. 9, 2023

Digital health funding, deals reach lowest levels in years

Digital health startups across the globe raised $3.4 billion across 348 deals in the second quarter, with mega-rounds making up more than a quarter of all funding.

By Emily Olsen • Aug. 7, 2023

Augmedics picks up Surgalign’s digital health assets for $900K

Surgalign is selling its assets under court supervision after filing for Chapter 11 bankruptcy protection.

By Susan Kelly • Aug. 1, 2023

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

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