Latest headlines

First AI device to help colon cancer early detection: FDA approves marketing

The U.S. Food and Drug Administration authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy. “Artificial intelligence has the potential to transform health care to better assist health care providers and improve patient care,” said Courtney H. Lias, Ph.D. acting director of the GastroRenal, ObGyn, General Hospital and Urology Devices Office in the FDA’s Center for Devices and Radiological Health. According to the National Institutes of Health, colorectal cancer is the third leading cause of death from cancer in the United States. Polyps or other precancerous growths in the rectum or the colon (large intestine) are considered early signs. More details on the FDA website.

FDA approval for implant to treat congenital heart disease

The U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT). The device, called the Harmony Transcatheter Pulmonary Valve (TPV) System, is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery, which is the current standard of care. The use of the Harmony valve may delay the time before a patient needs additional open-heart surgery. It can also potentially reduce the total number of open-heart surgeries required over an individual’s lifetime. More details on the FDA website.

EC approval for Siemens Healthineers/Varian merger

The European Commission (EC) has concluded its review of the planned merger between Siemens Healthineers AG and Varian Medical Systems, Inc. and approved the transaction subject to certain conditions. In accordance with its commitments, the company will continue to keep its imaging and oncology software solutions interoperable with third-party offerings in the future. This concerns the connection of imaging solutions for radiation therapy with third-party oncology software solutions (and vice versa) as well as respiratory motion devices. Detailed information and company statements on the merger can be found on the Siemens Healthineers website.