HONG KONG – South Korea’s Medical IP Co. Ltd., an artificial intelligence (AI)-based medical 3D printing and software company, has won the FDA’s nod for its medical imaging analysis solution Medical Image Processing (Medip).

HONG KONG – Pentax Medical Co., of Tokyo, has gained CE marking for its artificial intelligence-based polyp detector Discovery. The detector assists endoscopists in finding potential polyps during a colorectal examination. The software has been trained using more than 120,000 files from about 300 clinical cases.

Augmedics Inc., a Chicago-based startup focused on augmented reality (AR) applications in health care, has scored a 510(k) clearance from the U.S. FDA for its Xvision Spine system. The company launched the device, which provides surgeons with X-ray quality insights into a patient’s anatomy and real-time surgical navigation, on Monday, with distribution slated to begin in the new year. While the FDA has cleared other AR products, Xvision Spine (XVS) is the first to be indicated for guided surgery.

Heart failure is a leading cause of disability and death in the U.S., but many cases are diagnosed late due to limited access to echocardiography, the primary method of detecting the condition. To address that need, the U.S. FDA has granted breakthrough device designation to Eko Devices Inc., of Berkeley, Calif., for an electrocardiogram (ECG)-based algorithm that could serve as an easily accessible screening tool for heart failure during routine physical exams.

Digital therapeutics have made great strides in recent years, with Pear Therapeutics Inc. playing a key role. Now, the company has reported the dosing of the first patient in part two of a study assessing Pear-006 – which Pear Therapeutics is developing in collaboration with Basel, Switzerland-based Novartis AG – to address depressive symptoms in multiple sclerosis (MS).

PARIS – A team of medical researchers and engineers from the Gustave Roussy Institute, in Villejuif, France, and Paris-Sud University recently developed an artificial intelligence system called Resolved2, designed to assess prospective cancer drugs. As Loïc Verlingue, lead cancer specialist on the data science team at the Gustave Roussy Institute, explained to BioWorld MedTech, “this AI is intended to predict efficiently whether a cancer treatment molecule will achieve authorization or not within six years of pharmacological data and phase I clinical trials.”

HONG KONG – Boston-based consulting firm Analysis Group Inc. will be working with China’s Institute of Hematology & Blood Diseases Hospital (IHBDH) on developing a first-of-its-kind blood disease research platform. The National Longitudinal Cohort of Hematological Diseases in China (NICHE) is set to hold the information of more than 10,000 patients across China.

Caresyntax GmbH, a Berlin-based provider of surgical automation, analytics and AI software technologies, picked up $45.6 million in venture funding. The funds will be used to accelerate U.S. and global expansion and support continued development and deployment of Caresyntax products. Participating in the financing were Whiz Partners, a Takeda-back drug discovery gateway investment limited partnership, Plug and Play Tech Center, Barco Healthcare, Mitsubishi Corp., Relyens, IPF Partners and Caresyntax founders Dennis Kogan and Bjoern von Siemens.