Intuitive receives CE mark for transvaginal use of da Vinci SP system
September 20, 2026
The approval allows the da Vinci SP system to be utilised in more women’s health procedures across Europe.
The approval allows the da Vinci SP system to be utilised in more women’s health procedures across Europe.
NORCROSS, Ga., Sept. 18, 2026 /PRNewswire/ — Koning Health, a global leader in advanced breast imaging technology, today announced that the Koning Breast CT System has been successfully included in the Australian Register of Therapeutic Goods (ARTG), marking an important regulatory milestone for the company’s expansion into the Australian market.
DeepHealth has announced FDA 510(k) clearance for Chest XRay, one of the first FDA-cleared chest X-ray computer-aided detection (CADe) solutions built on a foundation model that detects and localizes suspected thoracic abnormalities on chest radiographs. The clearance marks a significant step in the company’s vision of bringing intelligence into every stage of the imaging experience.
The FDA has given the go-ahead to Ultragenyx’s rebisufligene etisparvovec—now to be marketed under the brand name Fayuvi—for the treatment of Sanfilippo syndrome type A, an ulta-rare, progressive neurological condition in children.
GOLETA, Calif., Sept. 16, 2026 /PRNewswire/ — Aptitude today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the next-generation Metrix® COVID Test, marking the company’s first FDA 510(k) clearance and the continued expansion of the Metrix molecular diagnostics platform. Development was supported by the Biomedical Advanced Research and Development Authority (BARDA).
Medtronic (NYSE: MDT) has received an FDA green light to bring its vessel-sealing technology over to its Hugo surgical robot, adding to the platform’s U.S. catalog of energy instruments.
Neptune Medical has landed an FDA clearance for its robotic system designed to provide stable control during colonoscopy.
Powerful Medical today announced FDA De Novo authorization for its Queen of Hearts AI ECG model.
Beta Bionics (NASDAQ: BBNX) has claimed an FDA clearance for its first patch pump insulin delivery system, amid plans to roll out an updated diabetes dosing algorithm and the launch of a new CGM partnership with Senseonics.
XCath Robotics has FDA Breakthrough Device Designation for its in-development Iris surgical robotic system for mechanical thrombectomy to treat acute ischemic stroke.