Carelight Ltd. reported seeking protection for a wearable real time opto-physiological monitoring system for monitoring heart rate, respiration rate, oxygen saturation, blood pressure, heart rate variability, pulse wave velocity, and body temperature.
The U.S. FDA posted two device warning letters in the first week of April 2024, including one each to Beckman Coulter Inc., of Brea, Calif., and Agena Bioscience Inc. of San Diego, the former of which was directed toward the Chaska, Minn., facility that manufactures the Beckman Coulter Dxl 9000 analyzer.
Artificial intelligence (AI) is steadily making inroads into the world of health care, and San Francisco-based Eko Health Inc. has taken up the AI call with a stethoscope developed in conjunction with the Mayo Clinic that can detect low ejection fraction of the heart.
Laboratory Corporation of America Holdings Inc. agreed to purchase select assets of Bioreference Health from Opko Health Inc. for $237.5 million in a deal slated to close in the second half of 2024. The transaction could be the start of a buying spree for the country’s second-largest independent laboratory testing service provider, as Labcorp management has laid out an acquisition strategy that focuses on higher-growth areas, particularly reproductive and women’s health.
In what represents its first patenting, Anjo.ai Inc seeks protection of systems for remote monitoring, early detection and notification for life-threatening allergic anaphylactic reactions using wearable sensors and artificial intelligence. The system can recognize an allergic reaction even before the visible symptoms appear.
It’s game time for Abbott Laboratories’ 15-minute concussion test now that FDA clearance is in hand. The I-Stat traumatic brain injury cartridge uses whole blood, allowing bedside assessment of patients without lab processing.
Exact Sciences Corp. reported on data showing high sensitivity and specificity for the non-endoscopic Oncoguard Esophagus test that is currently in development for the detection of esophageal adenocarcinoma (EAC) and its precursors, including Barrett’s esophagus.
Scientists from Abbvie Deutschland GmbH & Co. KG and Abbvie Inc. have identified radiolabeled compounds capable of imaging and targeting microtubule-associated protein Tau (PHF-tau; MAPT) aggregates acting as positron emission tomography (PET) imaging agents reported to be useful for the diagnosis of progressive supranuclear palsy.
Researchers from Massachusetts General Hospital recently detailed the discovery of [11C]SY-08, a new PET radiotracer that detects aggregated α-synuclein (α-Syn) fibrils in individuals with neurological disorders such as Parkinson’s disease, multiple system atrophy and dementia with Lewy bodies.
The U.S. FDA’s pending final rule for regulation of lab-developed tests has proven unusually controversial even for the FDA, but Rep. Anna Eshoo (D-Calif.) stated in a March 21 hearing that congressional inaction has left the agency in an uncomfortable spot.
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