Genedx LLC partnered with Illumina Inc. to test whether Illumina's constellation map read technology could shed light on hard-to-detect variants that appear in rare diseases. Constellation met or exceeded the ability of other sequencing methods to detect variants implicated in multiple disorders and worked across a range of sample types, a study presented at the American Society for Human Genetics (ASHG) Annual Meeting in Boston on Oct. 15 found. Read More
China’s National Medical Products Administration (NMPA) recently met with a delegation from Singapore’s Health Sciences Authority (HSA) to discuss cooperation in the two agencies’ regulation of medical products, part of a series of efforts by NMPA to expand its use of regulatory reliance. Read More
While the pace of executive orders (EOs) coming out of the White House has slowed, the Trump administration is still churning them out. As of the end of the third quarter, President Donald Trump had issued 209 EOs. Of those, BioWorld tracked 37 that directly impact drug and device R&D, regulatory burdens, pricing and market competition. Read More
Japan has long been one of the premier markets for medical technology, but this market has suffered from a reputation for slow adoption of technologies outside the cardiovascular device space, a problem the Pharmaceuticals and Medical Devices Agency is keen to address. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anteris Technologies, Bioaffinity Technologies, Caps Medical, Medical Microinstruments, Monod Bio, Surgibox. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Micro Interventional Devices, Ocusciences, Owlet, Vara. Read More