Prapela, Inc. Granted FDA De Novo for Breakthrough Therapy Helping the Most Vulnerable Victims of our Opioid Epidemic
Prapela’s SVS hospital bassinet pad is the first and only therapeutic medical device to treat opioid exposed newborns with neonatal opioid withdrawal syndrome. PORTLAND, ME, UNITED STATES, April 17, 2025 /EINPresswire.com/ — One of the more sorrowful consequences of our... Read More →
Approval Through FDA’s De Novo Pathway: A Major Accomplishment! featuring Osteoboost
In January 2024, Osteoboost achieved a notable regulatory milestone by receiving De Novo classification from the U.S. Food and Drug Administration (FDA). This designation is significant not only because FDA approval is a rigorous process but also because Osteoboost was... Read More →
Cutting Edge At-Home MedTech and Digital Health Companies, Satio and Nanowear, to Collaborate on Accelerating Non-invasive Biomarkers, Diagnostics and Drug Delivery, Beyond the Remote Monitoring and Digital Assessment Tools Used Today
BOSTON and NEW YORK, April 14, 2025 /PRNewswire/ — Satio and Nanowear have agreed to partner to advance patient-friendly, home-based diagnostic, and therapeutic care. This collaboration integrates Nanowear’s at-home AI-based nanotechnology biomarker diagnostic platform with Satio’s at-home blood draw diagnostics... Read More →
Innoblative Receives U.S. IDE Approval for its Novel Electrosurgical Device for Breast Cancer Treatment
Innoblative prepares to initiate its feasibility study, evaluating the safety and effectiveness of its SIRA® RFA Electrosurgical Device, an FDA Breakthrough Device, for patients undergoing breast-conserving surgery Breast cancer is the most commonly diagnosed cancer globally CHICAGO, April 10, 2025... Read More →
Puzzle Medical Devices Announces Closing of CAD 43 Million Funding Round to Complete Clinical Study Led by KF Matheson and Desjardins Capital
Montreal, QC, April 8, 2025 – Montreal-based startup Puzzle Medical Devices announced today the closing of a CA$43 million funding round. This round, led by KF Matheson and Desjardins Capital , with participation from Lumira Ventures , Longview Ventures ,... Read More →
Ypsomed and Sidekick Health launch a collaborative digital health solution for obesity management
NEW YORK, April 7, 2025 /PRNewswire/ — Ypsomed and Sidekick Health are launching an integrated digital health solution to better support people with obesity. Ypsomed’s autoinjectors seamlessly integrate into Sidekick’s digital health and chronic condition support app to help patients... Read More →
Healionics Granted US Patent for STARgraft Technology
SEATTLE, WA, UNITED STATES, April 2, 2025 /EINPresswire.com/ — Healionics Corporation, a developer of synthetic biomaterial-based medical devices, today announced that the U.S. Patent and Trademark Office has issued patent no. 12,263,077 titled “Vascular Grafts and Method for Preserving Patency... Read More →
Makani Science Receives FDA Clearance for Groundbreaking Respiratory Monitor
IRVINE, Calif., April 2, 2025 /PRNewswire/ — Makani Science, an innovator in wearable respiratory monitoring technology, today announced that it has achieved 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and distribute its Makani Respiratory Monitor.... Read More →
Bright Uro Receives FDA Clearance for Glean™ Urodynamics System
Innovative patient-developed technology improves comfort, data accuracy, ease of use IRVINE, Calif.–(BUSINESS WIRE)–Bright Uro, a medical device company with a mission to transform care for lower urinary tract dysfunction (LUTD) through innovations in urodynamics, today announced that the U.S. Food... Read More →
Zeto Unveils NeuroPulse, the First AI-Powered Status Epilepticus Software Using Full 10-20 EEG in Collaboration with encevis
SANTA CLARA, Calif., April 2, 2025 /PRNewswire/ — Zeto, Inc., a fast-growing medical technology company revolutionizing EEG diagnostics with its cutting-edge devices and advanced cloud platform, announces the integration of live bedside AI-powered Seizure Burden and Status Epilepticus detection. Utilizing... Read More →