Freenome’s lung cancer test receives FDA breakthrough status
August 13, 2026
The SimpleScreen test is designed to detect early lung cancer signals from a standard blood sample.
The SimpleScreen test is designed to detect early lung cancer signals from a standard blood sample.
FastWave Medical earned FDA investigational device exemption (IDE) approval for its next-generation intravascular lithotripsy (IVL) technology, the company announced today.
The device will be sold initially in the US and Canada, with further submissions planned in additional markets.
Wandercraft, a Paris-based robotics company, announced that the FDA has granted clearance for Eve, its personal self-balancing exoskeleton designed to support upright mobility.
MILAN, Aug. 11, 2026 /PRNewswire/ — Bracco Imaging today announced that VueJect®, its first dedicated ultrasound contrast delivery system engineered to support cardiology imaging specifically, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and authorization from Health Canada.
BEIJING, Aug. 11, 2026 /PRNewswire/ — Datasea Intelligent Technology Ltd. (NASDAQ: DTSS) (“Datasea” or the “Company”), a technology company focused on acoustic high-tech and AI multimodal digital solutions, today announced that Shuhai Jingwei (Shenzhen) Information Technology Co., Ltd. (“Shuhai Jingwei”), the Company’s variable interest entity in China, has completed establishment registration and device listing with the U.S. Food and Drug Administration (“FDA”) for its NeuroVibe Biofeedback System, including products NV-02 and NV-03.
Elevation’s FDA clearance for Saber-XA follows the agency’s clearance of its Saber-C AVIA cervical fixation device in July.
Acarix will launch the CADScor system in the UAE through UniTech Solutions, which will manage regional distribu
GENEVA, Aug. 11, 2026 /PRNewswire/ — Spineart announces that the BAGUERA® C cervical disc has received FDA approval for 1 and 2 contiguous levels, expanding access in the United States to a motion-preserving solution for patients suffering from cervical disc disease.
OKLAHOMA CITY, Aug. 10, 2026 /PRNewswire/ — Acarix AB (publ) today announced that the CADScor® System has received regulatory approval from the Emirates Drug Establishment (EDE) and the Ministry of Health and Prevention (MOHAP), clearing the way for commercial availability of the technology across the United Arab Emirates.