Medical Technologies

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

107 Articles

Medical Technologies

ARPA-H Allocates $62.7 Million to Develop Agentic AI for Cardiac Patient Care

ARPA-H announced its first contracts under the ADVOCATE program to build an agentic artificial intelligence system supporting heart failure patients between medical visits, while testing oversight and safety mechanisms and regulatory and implementation pathways in the United States.

2026-09-11

Medical Technologies

CMS Expands Medicare Coverage for TAVR to Include Patients With Asymptomatic Aortic Stenosis

The Centers for Medicare and Medicaid Services approved coverage for transcatheter aortic valve replacement for patients with severe aortic stenosis even without symptoms. Analysts expect Edwards Lifesciences to benefit particularly, while evidence continues to be collected on this patient group.

2026-09-11

Medical Technologies

FDA Guide for Small Businesses to Obtain Medical Device Fee Reductions or Waivers

The FDA explains the Small Business Determination program mechanism for companies seeking to reduce or waive medical device application fees, with different financial thresholds, documents, and deadlines depending on the type of benefit. Applications must be submitted electronically through the User Fee System and CDRH Portal, and status must be renewed each fiscal year.

2026-09-09

Medical Technologies

Labcorp Acquires MLM to Expand Its Laboratory Network and Support Clinical Trials Globally

Labcorp has acquired MLM Medical Labs to add central laboratory capabilities and biomarkers used in clinical trials. The deal gives the company a wholly owned laboratory network spanning North America, Europe, Asia and Africa, without disclosing its financial value.

2026-09-09

Medical Technologies

Four Questions Reveal FDA’s Expected Approach to Regulating Generative AI in Medical Devices

The U.S. Food and Drug Administration is developing guidance for using generative artificial intelligence in medical devices, focusing on competency-based evaluation, foundation models, and post-market monitoring. Fundamental questions remain open about the limits of oversight and companies’ responsibility for declining model performance over time.

2026-09-09

Medical Technologies

Apple Expands Health Features on Apple Watch and iPhone Through Apple Intelligence

Apple announced the Health Sensing System in Apple Watch Series 12 and Apple Watch Ultra 4, with more frequent heart measurements and a daily Readiness score, alongside a redesigned Health app with Apple Intelligence capabilities. The updates include support for perimenopause and menopause, at-home movement assessments, and laboratory testing services launching in the United States.

2026-09-09

Medical Technologies

FDA Warns Against Using Clear Aligners Without Medical Supervision

The U.S. Food and Drug Administration explains that clear aligners are prescription devices requiring evaluation and monitoring by a dentist or orthodontist. It warns against products sold directly to consumers without professional supervision, explains their risks, and describes how to verify device clearance.

2026-09-08

Medical Technologies

U.S. Documents Reveal Delays and Care Denials in Medicare Experiment Using Artificial Intelligence

The EFF published approximately 1,000 pages of documents obtained through a lawsuit against the U.S. government, saying they reveal lengthy delays, denials of treatment requests, and technical problems in the WISeR prior authorization model within Medicare. The documents raise questions about contractors’ incentives and the transparency of artificial intelligence systems that affect patients’ access to care.

2026-09-08

Medical Technologies

Elucid Raises $55 Million to Expand AI-Powered Cardiac Imaging Platform

Elucid raised $55 million in Series D funding to commercialize a cardiac imaging platform and strengthen its partnerships with medical device companies. The company is preparing to expand the use of Plaque-IQ while the FDA reviews its noninvasive FFR-CT product.

2026-09-08

Medical Technologies

Vara Receives CE Mark for a System That Independently Screens Breast Images in Normal Cases

Vara has received the first European approval for an artificial intelligence system capable of classifying some mammograms as normal and issuing the result without review by a radiologist. Other cases remain subject to human interpretation, while the system relies on a monitoring mechanism that can return the site to full physician reading.

2026-09-04

Medical Technologies

FDA Updates List of AI-Enabled Medical Devices and Prepares to Track Foundation Models

The U.S. Food and Drug Administration has updated its list of AI-enabled medical devices authorized for marketing in the United States, emphasizing that the list is not exhaustive and does not represent a complete database of all devices. The agency is exploring future mechanisms to identify devices that incorporate foundation models, including large language models and multimodal systems.

2026-09-03

Medical Technologies

Abbott’s Dual-Energy Catheter Achieves Full-Year Results in Complex Atrial Fibrillation Cases

Results from the FlexPulse IDE study showed that Abbott’s TactiFlex Duo catheter, which combines pulsed-field ablation and radiofrequency ablation, achieved efficacy and safety after one year of treating patients with paroxysmal atrial fibrillation. The company plans to use the data as the basis for submitting an application to the FDA to market the catheter in the United States.

2026-09-02

Medical Technologies

Medtronic to Invest $700 Million in Cornerstone Robotics and Distribute Sentire Robot Outside the United States

Medtronic plans to invest approximately $700 million in a partnership with Cornerstone Robotics, giving it the right to distribute the Sentire surgical robot in China, Singapore, and Europe alongside its own Hugo system. The move comes as the company expands its presence in the robotic surgery market and competes with established systems such as da Vinci.

2026-09-02

Medical Technologies

Enovis Acquires eCential Robotics to Develop Robotic Systems for Knee and Shoulder Surgery

Enovis announced the acquisition of French company eCential Robotics for €155 million upfront, with additional payments of up to €35 million tied to development milestones. The company aims to launch a robot for knee surgery in late 2028, followed by a system for shoulder surgery in 2029.

2026-09-02

Medical Technologies

OpenAI Integrates ChatGPT Health with Epic to Access Data on More Than 325 Million Patients

OpenAI announced the integration of ChatGPT Health with the Epic electronic health record system, allowing clinicians to summarize patient records and ask questions about them while keeping the integration read-only. It also launched the Healthcare Public Data app for accessing public health sources, amid ongoing debate over the safety of using artificial intelligence in healthcare.

2026-09-02

Medical Technologies

AI Glasses Help People Who Have Lost Their Voices Communicate Through Word Prediction and Object Recognition

Rocket Studio has transformed the Japanese syllabary into an interface inside MiRZA smart glasses, adding word suggestion, text-to-speech conversion, and recognition of surrounding objects. A trial involving 25 patients showed that the system reduced message-transfer time from minutes to tens of seconds or just a few seconds, but it still depends on the user's ability to move their head or finger.

2026-09-02

Medical Technologies

Medtronic Begins Its Fiscal Year with 13.7% Revenue Growth Driven by Cardiac Business

Medtronic generated $9.8 billion in revenue in the first fiscal quarter of FY27, up 13.7% year over year, driven particularly by its cardiac business and cardiac ablation solutions. The company raised its annual organic revenue growth outlook and also provided updates on the adoption of the Hugo surgical robot.

2026-09-01

Medical Technologies

GE HealthCare Obtains CE Mark for Photon-Counting CT Scanner

GE HealthCare’s Photonova Spectra has received a CE mark, paving the way for its commercial launch in European markets and other markets that accept the certification. The decision places the company in direct competition with Siemens Healthineers’ Naeotom Alpha scanners in the photon-counting computed tomography market.

2026-09-01