Digital Health: Page 3
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Sarah Silbiger/Getty Images via Getty Images
FDA official sets out approach to AI in medical devices
Developing quality assurance practices for AI models should be a priority, said Troy Tazbaz, director of the CDRH’s Digital Health Center of Excellence.
By Elise Reuter • June 18, 2024 -
Chip Somodevilla via Getty Images
Senators urge CMS to create AI payment pathway
Uniform reimbursement standards are needed to protect patient access to algorithm-based devices and ensure future innovation, the lawmakers said.
By Nick Paul Taylor • June 18, 2024 -
Explore the Trendline➔
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TrendlineMedical 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 -
Sarah Silbiger via Getty Images
FDA creates transparency principles for AI in medical devices
The agency worked with regulators in the U.K. and Canada to determine how key information about machine learning-enabled devices should be communicated.
By Nick Paul Taylor • June 17, 2024 -
SDI Productions via Getty Images
Zimmer, RevelAi partner to sell AI tool for orthopedic care
RevelAi uses generative artificial intelligence to automate clinical workflows and support patients with conditions such as osteoarthritis.
By Nick Paul Taylor • Updated June 14, 2024 -
Permission granted by ECRI
Q&AStronger oversight of AI needed in medical devices, ECRI CEO says
Marcus Schabacker called for more upfront regulations and postmarket monitoring to better understand how AI features affect patient care.
By Elise Reuter • June 5, 2024 -
Retrieved from Dexcom on June 05, 2024
Dexcom connects G7 CGM directly to Apple Watch in US
Apple Watch and G7 users can now view real-time glucose readings on their wrist, regardless of whether they are carrying an iPhone.
By Nick Paul Taylor • Updated June 7, 2024 -
Permission granted by Akili Interactive
Digital therapeutics firm Akili to sell for $34M
Akili, which makes a video game treatment for ADHD, will merge with Virtual Therapeutics to create a larger digital health entity.
By Elise Reuter • May 30, 2024 -
Permission granted by Otsuka Precision Health
Otsuka defies digital health downturn with new company
With “no playbook out there” to fall back on, the new company is taking a long-term approach as it develops its portfolio, an Otsuka Precision Health exec told MedTech Dive.
By Elise Reuter • May 29, 2024 -
Courtesy of H2O Therapeutics
FDA seeks AI tech to predict, detect Parkinson’s symptoms
By testing artificial intelligence and machine learning models, the agency hopes to come up with best practices for Parkinson’s measures from wearables and smartphones.
By Elise Reuter • May 21, 2024 -
deberarr via Getty Images
FDA targets health inequality by improving at-home devices
Michelle Tarver, an FDA official, said a new program is meant to advance health equity by considering people’s living conditions as part of medical device design.
By Elise Reuter • May 13, 2024 -
Courtesy of Tandem Diabetes Care
Tandem reports 224 injuries related to faulty insulin pump app
A problem with Tandem’s iPhone app could drain the battery of the connected insulin pump, causing it to power down sooner than expected.
By Nick Paul Taylor • May 9, 2024 -
Justin Sullivan via Getty Images
FDA qualifies Apple Watch AFib feature for use in clinical trials
Officials will accept atrial fibrillation data collected by the wearable as a secondary endpoint in studies of cardiac ablation devices.
By Nick Paul Taylor • May 6, 2024 -
Ramberg via Getty Images
UK sets out position on regulating AI as a medical device
Some AI products that currently can be put on the market without conformity assessment will move to a higher risk class, requiring more scrutiny.
By Nick Paul Taylor • May 3, 2024 -
Permission granted by Senseonics
Senseonics gets FDA clearance to pair CGM implant with insulin pumps
Analysts said the designation and planned one-year sensor could help Senseonics’ device appeal to more patients.
By Nick Paul Taylor • May 1, 2024 -
Courtesy of Exo
Exo adds FDA-cleared AI tools to handheld ultrasound system
Exo sees the new capabilities as especially helpful for healthcare providers in rural and under-resourced settings.
By Nick Paul Taylor • April 25, 2024 -
Justin Sullivan/Getty Images via Getty Images
Osso VR brings surgery training app to Apple Vision Pro
Users can virtually walk through the steps of two orthopedic procedures: total knee replacement and carpal tunnel release.
By Nick Paul Taylor • April 12, 2024 -
Permission granted by Synchron
Synchron launches patient registry to prepare for brain implant trial
The startup, which rivals Neuralink, is developing brain-computer interface technology that lets people control electronic devices hands-free.
By Elise Reuter • April 9, 2024 -
Permission granted by Prenosis
FDA grants de novo nod to AI tool for detecting sepsis
Prenosis CEO Bobby Reddy Jr. told MedTech Dive the company sees third-party validation as important, with the FDA having clarified that certain decision support tools should be regulated as medical devices.
By Elise Reuter • April 4, 2024 -
Permission granted by Eko Health
Eko wins FDA nod for AI to detect sign of heart failure using stethoscope
The clearance adds to the list of devices the FDA has authorized this year with AI algorithms to detect health conditions.
By Nick Paul Taylor • April 4, 2024 -
Permission granted by Osso VR
Osso VR to lay off 67 people at corporate HQ
Art and illustration jobs were heavily affected by the layoffs, which will be complete by May 27.
By Nick Paul Taylor • April 1, 2024 -
Courtesy of Sequel Med Tech
Deka’s automated insulin delivery system, powered by patient-led app, gets FDA clearance
Sequel Med Tech will sell the new system, which integrates with Tidepool’s Loop insulin dosing algorithm.
By Nick Paul Taylor • March 20, 2024 -
Getty Images via Getty Images
Better Therapeutics lays off staff, considers winding down business
The digital therapeutics developer received authorization for a Type 2 diabetes treatment app last year but has struggled for money.
By Nick Paul Taylor • March 15, 2024 -
zhuweiyi49 via Getty Images
AI to expand medtech portfolios, revenue streams: Moody’s
The rating agency predicts AI will start to have a positive impact on medical device companies in the next two years.
By Nick Paul Taylor • March 12, 2024 -
Michael M. Santiago / Staff via Getty Images
Siemens Healthineers launches anatomy hologram app on Apple Vision Pro
The prototype app has potential uses in patient communication, medical education and surgical planning.
By Nick Paul Taylor • March 8, 2024 -
Courtesy of Roche
Roche to take on Abbott, Dexcom with its first CGM
The new sensor is designed to last for 14 days but requires finger-stick calibration.
By Nick Paul Taylor • March 7, 2024
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