The U.S. FDA’s draft guidance for predetermined change control protocols for all device types fills in a gap left by previous draft guidance, but there is one potential stopping point for class III devices.
A new brain-computer interface (BCI) developed at UC Davis Health is able to translate brain signals into speech with up to 97% accuracy – the most accurate system of its kind.
The U.S. Federal Trade Commission’s broad rule banning noncompete employment clauses has been struck down by the U.S. District Court for the Northern District of Texas. In a final judgment from Judge Ada Brown, the court set aside the noncompete rule, saying it won’t be enforced or take effect as had been planned on Sept. 4.
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.
The U.S. FDA approved Janssen Biotech Inc.’s Rybrevant (amivantamab-vmjw) plus a new oral tyrosine kinase inhibitor called Lazcluze (lazertinib) as a first-line combination treatment to treat select non-small-cell lung cancers.
Cresilon Inc. secured U.S. FDA clearance for Traumagel, a hydrogel that stops potentially life-threatening bleeding in seconds. Cresilon designed the product for use by the U.S. military, first responders and medical professionals to swiftly and effectively stop bleeding from traumatic wounds
Algodx AB received U.S. FDA 510(k) clearance for its sepsis detection software Navoy CDS. The technology, which analyzes patient data, has the potential to improve patient outcomes as it enables clinicians to detect and treat sepsis earlier.
The U.S. FDA’s effort to regulate lab-developed tests was predictably controversial, but the final rule drew a second lawsuit, this time from the Association for Molecular Pathology.
A long-term look at obese and overweight patients with pre-diabetes found that weekly injections of Eli Lilly and Co.’s tirzepatide led to a 94% reduction in their risk of progression to type 2 diabetes compared to placebo – a result that Leerink Partners analyst David Risinger called “exceptional.”
In its fifth year of transcription factor discovery, Talus Bioscience Inc. just raised $11.2 million in new venture funding. Seattle-based Talus will use the money to further develop its MARMOT (Multiplexed Assays for the Rational Modulation Of Transcription Factors) platform.
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