Sidekick Health AB stepped into a leading role in the fast-growing digital health space with the closing of a $55 million series B this week and an ever larger number of partners for its gamified app. Designed to help better manage multiple chronic conditions, the digital therapeutic engages users in video game-like activities and rewards positive changes in lifestyle choices while delivering personalized educational components.
Mark it as a day to remember. The U.S. FDA has awarded de novo marketing authorization for the first in vitro diagnostic (IVD) test for Alzheimer’s disease (AD), enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.
Mark it as a day to remember. Today the FDA authorized the first in vitro diagnostic test for Alzheimer’s disease, enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.
Orthofix Medical Inc. continues to expand its bone growth product line with a new premarket approval from the FDA for its Accelstim bone healing therapy device. Indicated for certain fresh fractures and fractures that have not healed, the device uses low-intensity pulsed ultrasound to stimulate the natural healing process. The company plans to take a phased approach to the launch, which will begin within weeks.
Isono Health Inc. received FDA clearance for its Automated Three-dimensional Ultrasound with Artificial intelligence (ATUSA) system for breast imaging, a wearable, compact automated whole breast ultrasound system that can acquire high-quality images without requiring a skilled operator. The ultrasound scan takes two minutes to scan the entire breast volume and offers 3D visualization of the breast tissue.
Four months after debuting W1 health watch at Arab Health 2022, Masimo Corp. reported a limited release of the consumer version of the device in the U.S. to 10,000 users on a first come-first served basis. The wrist-worn device, which measures oxygen saturation, pulse rate, perfusion index, pleth variability index and respiration rate, also counts steps and detects falls.
Hello Heart Inc. more than doubled its fundraising to date with a $70 million series D financing round showing heart-warming support from investors for its digital therapeutic solution. Growth equity firm Stripes led the round, which brought the heart-focused digital therapeutic company’s total raised to date to more than $138 million.
With one-quarter of China’s population affected by rolling shutdowns, manufacturers worldwide are preparing for a summer of supply chain nightmares. Shanghai and its normally bustling port have been closed now for a month and the nation’s COVID-Zero policy is now threatening Beijing. So far, though, the med-tech industry remains minimally affected, but the coming months may tell a different story.
Investors showed some love to French remote patient monitoring and cardiac data startup Implicity SAS, contributing $23 million to the company’s series A financing round. New investors Crédit Mutuel Innovation and Bpifrance led the round with support from BNP Paribas Development and returning seed investors Serena, Xange and Karista.
The American Society of Clinical Oncology (ASCO) updated its guidelines to recommend use of Biotheranostics Inc.’ Breast Cancer Index (BCI) molecular gene-expression test to aid decisions on extended endocrine therapy in certain patients with the most common type of breast cancer.
