AI devices need dedicated FDA regulatory pathway to reduce bias risk, say researchers

Scientists argue for a new regulatory process to prevent AI software from reinforcing existing health disparities.

By Nick Paul Taylor • Feb. 16, 2023

Insulet pays Bigfoot Biomedical $25M for pump-based automated insulin delivery technology

Insulet framed the Bigfoot deal as a way to double its IP portfolio and strengthen its position in the insulin pump market.

By Nick Paul Taylor • Feb. 14, 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

How the right infrastructure increases the resilience of your HealthTech devices

Ensure your HealthTech devices are always available, always secure and always up-to-date.

Feb. 13, 2023

GE HealthCare agrees to buy AI imaging firm Caption Health in second acquisition

GE HealthCare plans to pair its ultrasound machines with Caption’s applications for early disease detection.

By Elise Reuter • Feb. 10, 2023

Bayer partners with Huma to create online tool for assessing cardiovascular risk factors

The algorithm uses a large-scale biomedical database to predict whether a person is at higher, average or lower risk of developing heart disease over the next 10 years.

By Nick Paul Taylor • Feb. 7, 2023

Sensor-loaded, $1 smart glove being tested to reduce stillbirths, maternal deaths

The researchers plan to run clinical trials to show if the device can provide an early warning system for physical impediments to birth.

By Nick Paul Taylor • Feb. 6, 2023

FTC orders GoodRx to stop sharing users’ health data with advertisers, issues $1.5M fine

Regulators said they are putting the industry on watch with the enforcement against GoodRx, which allegedly collected data, including patient medications, and shared it without user consent.

By Rebecca Pifer • Updated Feb. 1, 2023

CFO survey hints at funding shift from robots to wearables

The poll from accounting firm BDO found the cost and regulatory hurdles of developing robotics devices are often too high, and lower-cost, less-regulated wearables offer better returns.

By Susan Kelly • Feb. 1, 2023

Medtech M&A outlook for 2023: Spinoffs, China exits, AI opportunities poised to spur deal rebound

Companies flush with cash are looking for good investments and innovative products that can reduce procedure costs, industry observers say.

By Peter Green • Jan. 31, 2023

Medtronic wearable partner files for bankruptcy but plans to continue ‘without interruption’

Rockley Photonics works with two of the top five medtech companies, plus six leading smart watch makers including Apple, but has run into financial problems.

By Nick Paul Taylor • Jan. 27, 2023

Why medical device designers need to become more agile — and how they can do it

To stay competitive, medtech firms must center manufacturing in business optimization plans, while embracing a design-to-value approach, says Jennifer Samproni, Flex’s chief technology officer for its Health Solutions division.

By Jennifer Samproni • Jan. 26, 2023

Stanford team reports progress with Theranos-like finger prick blood test

The researchers have created a system for capturing and analyzing thousands of molecules from a single drop of blood.

By Nick Paul Taylor • Jan. 23, 2023

Realizing the promise of AI for medical imaging and diagnosis

Alissa Hsu Lynch, global lead for MedTech Strategy & Solutions at Google Cloud, explains how medtech companies can benefit from applying AI to the explosion of medical imaging data.

By Alissa Hsu Lynch, global lead for MedTech Strategy & Solutions at Google Cloud • Jan. 19, 2023

Bayer to buy AI imaging platform Blackford Analysis to bolster radiology growth strategy

Bayer aims to outpace the broader radiology segment by investing in fast-growing technologies such as imaging AI.

By Elise Reuter • Updated Jan. 18, 2023

Akili cuts 30% of staff to focus cash on growing prescription video game sales

The move comes as the company seeks a path forward after sales of $82,000 in the third quarter. Over the last five months, its share price has fallen 90%.

By Nick Paul Taylor • Jan. 13, 2023

Google sibling Verily to lay off about 200 workers as it focuses on precision risk business

The company, which has more than 1,600 employees, will stop work on some products including its healthcare analytics software program.

By Nick Paul Taylor • Jan. 12, 2023

Apple Watch infringed on Masimo patent, judge rules, raising prospect of import ban

Masimo’s CEO said the ruling “exposes Apple as a company that takes other companies’ innovations and repackages them.”

By Nick Paul Taylor • Updated Jan. 12, 2023

Beta Bionics hires Harvard diabetes expert as CMO ahead of artificial pancreas launch

Steven Russell has joined the company as chief medical officer, completing a new leadership team that began taking shape with the appointment of Sean Saint as CEO last year.

By Nick Paul Taylor • Jan. 10, 2023

Cardiac wearable maker iRhythm sees ‘nice progress’ in recovering from Q3 challenges

The company reported more than 20% growth in patient registration and improvement in its returned device rate.

By Nick Paul Taylor • Jan. 10, 2023

Apple infringed on AliveCor wearable patents, ITC says in final ruling; import ban suspended

The commission found that Apple has infringed on two AliveCor patents and thereby violated a law that can trigger an import ban.

By Nick Paul Taylor • Jan. 4, 2023

Olympus agrees to $80M takeover of artificial intelligence endoscopy startup Odin Vision

The acquisition gives Olympus control of cloud-based AI systems to help detect and characterize cancerous and precancerous tissues during colonoscopies and gastroscopies.

By Nick Paul Taylor • Dec. 21, 2022

As diabetes technology advances, blood glucose control declines: study

Mexican-American and non-Hispanic Black adults saw the greatest drop as the proportion of patients with glycemic control fell from 29.2% between 1988 and 1994 to 27.5% between 2013 and 2020.

By Nick Paul Taylor • Dec. 21, 2022

Novo Nordisk expands Amalgam Rx insulin app pact, plots integration with other devices

Supported by Novo Nordisk, Amalgam Rx will incorporate and integrate with connected insulin delivery devices, continuous glucose monitors and electronic health records.

By Nick Paul Taylor • Dec. 20, 2022

Click wins FDA breakthrough designation for prescription digital migraine therapy

The designation would give Click Therapeutics expedited review of its preventive treatment for episodic migraine in adults. 

By Nick Paul Taylor • Dec. 19, 2022

Pfizer to partner with Mayo Clinic spinoff on early cardiac amyloidosis detection

Anumana and Pfizer will build an algorithm using ECG data to identify patients who may be at risk of developing the serious heart condition.

By Elise Reuter • Dec. 16, 2022