Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Medtech, DNA Genotekm, Global Instrumentation, Perspectum.
Using Rhythm AI Ltd.'s stochastic trajectory analysis of ranked signals (STAR) mapping system with pulmonary vein isolation terminated and eliminated recurrence of persistent atrial fibrillation (AF) at much higher rates than other ablation procedures in a study published in the Journal of Cardiovascular Electrophysiology. The artificial intelligence-driven STAR mapping process collects and analyzes thousands of heart signals to precisely identify the areas of the heart responsible for the errant electrical signals causing atrial fibrillation, enabling more thorough and accurate ablation.
TORONTO – Calgary-based Circle Cardiovascular Imaging Inc. is receiving CA$2.65 million (US$2.09 million) in funding from the Canadian government’s Western Diversification Program (WDP), which represents nearly half of the more than CA$5.5 million (US$3.35 million) investment made to four Alberta-based organizations and companies. Company CEO Greg Ogrodnick attributes this to Circle Cardiovascular’s position “as the world leader in cardiovascular imaging.”
IBM Research and Boston Scientific Corp. are harnessing artificial intelligence (AI) to create an objective pain measurement tool that could someday replace standard patient-reported pain scales in the assessment of chronic pain.
TORONTO – Pointclickcare Technologies Inc. has followed up a series of private sector investments and purchases with its acquisition of Collective Medical Inc. and its real‐time notification platform for streamlining transitions from one stage of health care to another and reducing unnecessary length of stay and patient admissions. One of this country’s largest software companies, Pointclickcare said the US$500 million plus acquisition will pair its “rich, post‐acute data set” with Collective Medical’s network of more than 1,300 hospitals and other health care organizations across 39 states.
Theranica Bioelectronics Ltd. has snagged an expanded clearance from the U.S. FDA for use of its smartphone-controlled Nerivio device to treat migraines in adolescents. The new indication, for acute treatment of episodic or chronic migraine in people 12 years and older, is supported by a study published last month in the journal Headache.
Brain Scientific Inc., a neurology-focused device and software company, is seeking to combine a miniaturized electroencephalogram (EEG) with subcutaneous graphene electrodes to produce a minimally invasive brain monitoring device that could provide continuous data on patients with neurological conditions. The device, which the New York-based company is calling the Brain E-Tattoo, would monitor brain wave activity outside the clinical setting, allowing for long-term continuous data collection without interrupting daily life.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Telehealth bill resurfaces in 117th Congress; OIG includes telehealth in FY 2021 workplan.
New funding to the tune of $8 million in series B investment moves Oncohost Ltd. a good bit closer to bringing its personalized immunotherapy prediction platform to market and key operations to the U.S.
New funding to the tune of $8 million in series B investment moves Oncohost Ltd. a good bit closer to bringing its personalized immunotherapy prediction platform to market and key operations to the U.S. Ourcrowd, an investment platform that simplifies investment by accredited investors and others in startups, early-stage companies and venture funds, led the round. Other participants included a group of family offices and private investors.