Cala Health Inc. is moving quickly to establish leadership in treatment for essential tremor with its recent inclusion in the International Essential Tremor Foundation (IETF) guidelines as the only non-pharmacological, non-surgical treatment recommended and positive treatment results from a real-world study. “We’re very pleased with the validation from IETF and the research presented at MDS that demonstrates the impactful benefit of our therapy for those suffering from essential tremor,” said Kate Rosenbluth, founder and chief science officer of Cala Health. Read More
Startup company Medial Earlysign Ltd. and Roche Diagnostics International Ltd. are teaming up to bring to market artificial intelligence (AI) solutions for early detection of cancer. Founded in 2013, Tel Aviv-based Medial Earlysign uses machine learning tools to flag patients with a high probability of developing specific illnesses. The partnership with Roche will initially focus on gastric cancer. Read More
The med-tech market in China has lured many device makers and investors into doing business there despite concerns about intellectual property (IP) theft. While some of those IP theft worries have eased, China’s National Medical Products Administration (NMPA) is still implementing an order that came into force June 1, creating an environment of massive regulatory uncertainty that will force device makers to navigate carefully when attempting to access the world’s largest med-tech market. Read More
Lunit Inc. won an innovative medical device designation from South Korea’s Ministry of Food and Drug Safety (MFDS). The designation was for Lunit Insight MMG, its commercial artificial intelligence (AI) solution for breast cancer detection from mammography images. The company said that Lunit Insight MMG is now the first medical device of its type to receive the designation, and the company now has its second innovative medical device designation. “All of our commercialized products are now designated innovative medical devices by the MFDS. We will ensure that our Lunit Insight AI products allow medical staff to rapidly and accurately diagnose patients,” said Beomseok Suh, CEO at Lunit. Read More
PARIS – Researchers at the Institute for Surface Technologies and Photonics in Weiz, Austria, and the Institute of Scientific and Industrial Research Osaka University, Japan, have invented new ultra-flexible health monitoring patches that use harvested bio-mechanical energy. “These new devices represent a wireless e-health patch for accurate pulse and blood pressure monitoring,” Andreas Petritz, from the Institute for Surface Technologies and Photonics (the materials research unit of Joanneum Research FmbH), told BioWorld.Read More
Med-tech firms raising money in public or private financings, including: Amulet Capital Partners, Ginkgo Bioworks, Ixlayer, Prospection, Salesforce Ventures, Soaring Eagle. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ambiopharm, Axonics Modulation Technologies, CEM, De Novo Software, Dermtech, Ginkgo Bioworks, Insightful Science, Medtronic, Twist Bioscience, Vitalconnect, Waters. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anika, Electrocore, Intravent, Quanterix. Read More
