Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Attune Medical, Beacon Biosignals, Venus Concept.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcam, Akili Interactive, Alpha Tau, Danaher, Fluidai, GE Healthcare, Laboratorio Curie, Mayo Clinic, Natera, Nemaura Medical, Nerv Technology, Pathmaker Neurosystems, Sohomd, Sophia Genetics, Suvoda, Withings.
Awak Technologies Pte Ltd. raised more than $20 million in a series B round that will position the company to potentially transform the management of chronic kidney disease with its wearable and portable peritoneal dialysis (PD) device designed to enable patients with end-stage kidney disease to have dialysis on the go.
China’s National Medical Products Administration (NMPA) has largely completed its development of overarching regulations for medical devices and is now drilling down into more granular matter, such as a guidance on assessments of benefits and risks for medical devices. Grace Fu Palma, CEO of China Med Device LLC, told BioWorld that this new guidance is a much more detailed version of the 2019 edition, but added that China’s anticorruption efforts will be ramped up with an eye toward health care, just one of several current and impending developments of interest in this massive market.
An international team of researchers have developed a new blood test that could detect Parkinson’s disease earlier than current methods. The test, a real-time PCR-based assay, called Mito Dnadx, uses blood to identify damage to mitochondrial DNA (mtDNA) caused by the neurodegenerative condition. Based on the findings published in the journal Science Translational Medicine, the test could allow rapid, noninvasive and accurate identification of Parkinson’s disease (PD) before it causes much damage to the nervous system.
Arizona State University (ASU) reported the receipt of a patent for a device with colorimetric sensors for measuring excreted ketones in a body fluid. Additional sensors may be incorporated to measure flow rate of the body fluid, barometric pressure, humidity, and chemicals such as oxygen and carbon dioxide present in the fluid, and a system to measure metabolic rate and respiratory quotient via oxygen consumption rate and carbon dioxide production rate.
Orthofix Medical Inc. terminated its CEO, chief financial officer and chief legal officer in a move that plunged the stock from $18.63 at Monday’s close to $13.01 by the end of Tuesday. The clean sweep of the executive suite followed the “unanimous decision by the board’s independent directors to terminate for cause Keith Valentine, John Bostjancic and Patrick Keran,” the company said in a statement that named their interim replacements. Valentine was also asked to resign from the board.
RSS
