FDA creates a “super office” to manage device cybersecurity and digital health
The FDA's Center for Devices and Radiological Health (CDRH) has announced the elevation of the Office of Strategic Partnerships and Technology Innovat…
Tag: Press Release
Orion Corporation and Newel Health enter into licensing agreement for a digital therapeutic (DTx) ODD-403 (“Rohkea”) in pain
Orion Corporation (“Orion”) and Newel Health (“Newel”) have entered into a license agreement regarding ODD-403 (“Rohkea”), a digital therapeutic (DTx)…
Deliberate AI Announces its Depression and Anxiety Model, AI-COA™, is the First AI/ML Initiative to Be Accepted into the FDA’s ISTAND Pilot Program to Advance Drug Development
-Deliberate AI, a digital health technology company that delivers precision measurement of mental health through AI, today announced its inclusion in the U.S. Food and Drug Administration (FDA) Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program.
WellTheory Launches Autoimmune Care to Maven Clinic Workforce
ATHERTON, Calif.--(BUSINESS WIRE)--WellTheory, a first-of-its-kind virtual solution for the 50 million Americans suffering with autoimmune disease, to…
Element Science Receives CE Mark & UKCA Mark for the Jewel® Patch-Wearable Cardioverter Defibrillator
Element Science, an innovative health technology company pioneering a digital wearable platform for high-risk cardiovascular patients, announced that it has received the European Union’s CE mark certification and Great Britain’s UK Conformity Assessed (UKCA) marking for its novel Patch Wearable Cardioverter Defibrillator (P-WCD) from its Notified Body, the BSI Group.
Swift Medical Announces New Financing Round to Further Enhance Its AI-Based Wound Care Technology
wift Medical, a digital health technology company serving wound care providers, is pleased to announce the successful closing of an $US8M round of financing co-led by current investors BDC Capital’s Women in Technology Venture Fund and funds managed by Virgo Investment Group.
Genialis and Debiopharm Set Up Biomarker Discovery Collaboration
Genialis, the RNA-biomarker company, and Debiopharm, a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, have reached an agreement to define and discover biomarkers within the DNA Damage Repair (DDR) biology space to predict the clinical benefit of one or more drugs in Debiopharm’s pipeline.
Samsung Introduces Lunit AI Solutions for Enhanced Chest Screenings
Boston Imaging, the United States headquarters of Samsung’s digital radiography (DR) and ultrasound business, today announced that Samsung has signed a supply contract with Lunit Inc., a leading provider of artificial intelligence (AI) powered solutions for cancer diagnostics and therapeutics, to enable faster and more accurate chest screenings for timely interventions with improved patient outcomes.
Isaac Health Raises $5.7M to End Dementia Care Deserts and Build the Future of Brain Health Care Delivery
Isaac Health, a digital health company emerging as a national leader for brain health, announced today the successful completion of its oversubscribed $5.7 million Seed round. The round was led by Meridian Street Capital and B Capital with participation from Primetime Partners, Co-Found Partners, VU Venture Partners, and AirAngels.
Cross-Border Impact Ventures Exceeds $90 Million in Final Close of Its Women’s and Children’s Health Technology Fund
Cross-Border Impact Ventures (CBIV) today announced the final closing of its first fund after exceeding US$90 million in investor commitments. The Women’s and Children’s Health Technology Fund is focused on investments in technology companies that address the health needs of women, children, and adolescents or make health systems more resilient.