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. Read More
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.
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. Read More
The U.S. FTC put brand drug companies on notice Sept. 14 when the commissioners unanimously voted, 3-0, to issue a policy statement recognizing that improperly listed patents in the FDA’s Orange Book “may constitute an unfair method of competition.” Read More
Authors of a multi-center study welcomed results from a device that works with a smartphone or tablet to capture medical images for a more detailed understanding of infected wounds. By capturing heat produced by a wound and using bacterial fluorescence, the Swift Ray 1 developed by Swift Medical Inc., may help clinicians tell the difference between inflammation and a potentially dangerous infection.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Affluent Medical, Lunit, Nemaura Medical. Read More
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. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Attune Medical, Beacon Biosignals, Venus Concept. Read More
