In August, Cala Health Inc. reported results from its pivotal PROSPECT study showing significant improvement in hand tremors with use of its Cala Trio wearable neuromodulation therapy. Now the company has real-world evidence affirming the benefit to patients with essential tremor (ET) who used Cala Trio at home over several months. Read More
B-Temia Inc.’s Keeogo mobility device is on the move in the U.S. now that it has received 510(k) clearance from the U.S. FDA. Unlike currently available exoskeletons that move for patients, the Keeogo (keep on going) Dermoskeleton system amplifies signals from patients who can initiate movement but need additional assistance. Read More
China’s provincial government for Hainan Province has two sets of medical devices going through the urgent medical device needs program, but leveraging this program for regulatory approval in China is still no small undertaking. One complication is that any real-world evidence gathered in Hainan might not suffice for nationwide regulatory approval, but patient recruitment is also difficult. Read More
TORONTO – Most doctors recognize the symptoms instantly: hand tremors, slurred speech, impaired posture and balance. What they don’t always associate with people suffering from Parkinson’s disease are hallucinations and delusions. Read More
Precision oncology company Genetron Holdings Ltd. will help develop a liquid biopsy-based malignant tumor screening and early detection testing kit based on its mutation capsule technology. Read More
The BioWorld Artificial Intelligence price-weighted index, which includes biopharmaceutical companies, medical devices and health care services companies, has climbed in value and is currently up almost 37% year-to-date. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Spectral Imaging, Astrazeneca, Avita Therapeutics, Bio-Techne, Guided Therapeutics, Kantaro Biosciences, Luminultra, Meridian, Mimedx, Mount Sinai Health, Natera, Nevro, Shandong Yaohua Medical Instrument, Staar Surgical, Telo Genomics, Thermo Fisher Scientific, Transenterix. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, B-Temia, Fitbit, Micron Medical. Read More
Keeping you up to date on recent developments in cardiology, including: SCAD vs. plaques in heart attacks; Gut microbiome data may be helpful in routine screening of cardiovascular disease; Some health care professionals use outdated guidelines to screen and diagnose hypertension. Read More
