MGI Tech Co. Ltd. raised ¥3.602 billion (US$518 million) on the Shanghai STAR Market. Shares (SHA: 688114) debuted at ¥87.18 apiece on the first trading day on Sept. 9. They closed at ¥124 per share on Sept. 14. Read More
Sometimes it is a good idea to go to the dark side, particularly for individuals with undiagnosed vision impairment. Dark adaptation is one of the first aspects of vision to become impaired by age-related macular degeneration (AMD), so identifying it at early stages can preserve sight. Heru Inc. recently launched a new modality for its wearable screening platform to quickly assess dark adaptation. Read More
The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and manufacturing activities. Read More
From the beginning of the monkeypox outbreak in the U.S. in May, the federal government has bungled the response, according to both Democratic and Republican members of the Senate Health, Education, Labor and Pensions (HELP) Committee. Read More
A new generation of chimeric antigen receptor (CAR) T-cell therapies with advanced functions could hold the answer to improved safety and efficacy for these effective but potentially dangerous cancer therapies, shows research led by Boston University. The scientists showed it is possible to add ‘on’ or ‘off’ switches to CAR T cells, which can be activated using oral drugs with a known safety profile. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bioaffinity Technologies, Lunit, Nordic Bioscience, Smith+Nephew. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Cardiac Implants, Foundation Medicine, Jenavalve, Know Labs, Radiopharm, Relay Therapeutics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diasorin, Tasso. Read More
