Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aptar, Scanogen.
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.
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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Micro Interventional Devices, Ocusciences, Owlet, Vara.
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.
Patent litigation doesn’t always create outlandish damages awards but when it does, the outlandishness typically trends toward inordinately large sums. This was decidedly not the case in the Federal Circuit hearing in a patent lawsuit pitting Intuitive Surgical Inc., of Sunnyvale, Calif., against Rex Medical LP, of Conshohocken, Pa., given the damages awarded to Rex amounted to a mere $1.