Medical Technologies

Medical devices, digital health, medical artificial intelligence, surgical robots, and diagnostic technologies.

107 Articles

U.S. Food and Drug Administration Selects Three Participants in Digital Health Device Pilot Program

Medical Technologies

U.S. Food and Drug Administration Selects Three Participants in Digital Health Device Pilot Program

The FDA selected three manufacturers to participate in the TEMPO pilot program, which aims to expand access to digital health devices intended to improve outcomes for patients with chronic diseases under the ACCESS model. The companies will collect real-world use data, while the FDA has not yet evaluated the effectiveness of the devices for the specific uses covered by the program.

2026-08-16

Senseonics Completes Transfer of Eversense 365 Sales to Internal Management and Plans Fully Implantable Sensor

Medical Technologies

Senseonics Completes Transfer of Eversense 365 Sales to Internal Management and Plans Fully Implantable Sensor

Senseonics has completed the transfer of marketing and sales operations for the Eversense 365 continuous glucose monitor from Ascensia Diabetes Care to its internal teams in the United States and Europe, coinciding with record revenue of $14.5 million in the second quarter. The company is developing a fully implantable version of the sensor capable of communicating directly with a phone for one year.

2026-08-13

Medical Device Companies Support MDUFA VI Agreement, While Patients Call for Stronger Post-Market Safety

Medical Technologies

Medical Device Companies Support MDUFA VI Agreement, While Patients Call for Stronger Post-Market Safety

The latest agreement to fund medical device fees in the United States enjoys broad industry support, but patient groups are calling for expanded use of real-world evidence to monitor devices after they reach the market. The agreement includes higher fees for foreign companies, greater transparency regarding staffing at the medical device division, and the conversion of the TAP program into a permanent program.

2026-08-10

When Is Building Software Better Than Buying It? NYU Langone and Dana-Farber’s Experience Supporting Cancer Treatment Decisions

Medical Technologies

When Is Building Software Better Than Buying It? NYU Langone and Dana-Farber’s Experience Supporting Cancer Treatment Decisions

NYU Langone Health and Dana-Farber Cancer Institute developed the Solavia Decision Suite to help oncologists connect patient data with research, guidelines, and treatments within the electronic health record. After testing it internally, the platform became commercially available to other health systems in an experience that highlights the criteria for choosing between building and buying software.

2026-08-10

FDA Sets Design and Marketing Considerations for Over-the-Counter Medical Devices

Medical Technologies

FDA Sets Design and Marketing Considerations for Over-the-Counter Medical Devices

The U.S. Food and Drug Administration (FDA) explains the regulatory and design standards that manufacturers of over-the-counter medical devices should consider, from usability and labeling to clinical evidence and connected software. It also explains when a new 510(k), De Novo request, or PMA application may be required when converting a device from prescription use to direct-to-consumer use.

2026-08-02

Six Trends That Reshaped the Landscape of Medical Innovation in 2025

Medical Technologies

Six Trends That Reshaped the Landscape of Medical Innovation in 2025

IEEE Spectrum’s review of the most prominent biomedical stories of 2025 highlights a mix of artificial intelligence applications and older technologies repurposed for new uses, from brain implants and graphene tattoos to Wi-Fi heart monitoring and robotic surgery. These examples reveal promising opportunities, but they remain at varying research or experimental stages and face challenges related to accuracy, safety, and privacy.

2025-12-21