AccurKardia Announces Clinical Pilot Study of Its AK+ Guard ECG-based, AI-powered Hyperkalemia Detection Software
NEW YORK–(BUSINESS WIRE)–AccurKardia, an innovator in ECG-based diagnostics technology, has announced the initiation of a multicenter clinical pilot of AK+ GuardTM, an FDA Breakthrough Device Designated AI-powered technology that enables the detection of hyperkalemia using Lead I ECG. The three-arm... Read More →
ClearCam Awarded Breakthrough Technology Designation Agreement with Premier, Inc.
AUSTIN, Texas, Sept. 16, 2025 /PRNewswire/ — ClearCam, Inc., an Austin-based medical device company, has been awarded a national group purchasing agreement for Breakthrough Technology with Premier, Inc. Effective September 15, 2025, the new agreement allows Premier members, at their... Read More →
ZKR Orthopedics Announces First Patella LIFT™ Surgeries on the East Coast at Hospital for Special Surgery in Enrollment of FDA PELICAN Trial
NEW YORK, Sept. 16, 2025 (GLOBE NEWSWIRE) — ZKR Orthopedics announced today that the first Patella LIFT™ procedures on the East Coast were successfully performed as part of the PELICAN TRIAL, at the renowned Hospital for Special Surgery (HSS) in... Read More →
Raydiant Oximetry Names Michael Nagel to Lead the Company into its Device Commercialization Stage as CEO
SAN RAMON, CA, UNITED STATES, September 16, 2025 /EINPresswire.com/ — Raydiant Oximetry, Inc., a clinical-stage medical device company developing fetal monitoring innovations using advanced biophotonics and machine learning to improve outcomes during childbirth, today announced the appointment of Michael Nagel... Read More →
SutureTech Announces FDA 510(k) Clearance for RapidFix™, Its All – Suture Staple Device for Soft Tissue Repair
Durham, NC — September 16, 2025 — SutureTech, a surgeon-founded medical device company focused on advancing soft tissue and tendon repair, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for RapidFix™, its flagship device.... Read More →
Neurescue’s resuscitation device nets European approval for non-shockable cardiac arrests
Not all cardiac arrests can be treated with an electric shock. In fact, most of them—about 80%—are ineligible for defibrillation. With a survival rate of about 4%, these deaths continue to number between 7 million and 9 million per year.... Read More →
GE HealthCare inks Icometrix buyout to acquire brain MRI software
The deal includes AI-powered software for detecting known side effects of recently launched Alzheimer’s drugs. Dive Brief: GE HealthCare has struck a deal to buy brain analysis business Icometrix for an undisclosed sum, the companies said Wednesday. Icometrix received 510(k)... Read More →
Asabys Partners Leads €10 Million Extension of SafeHeal’s Oversubscribed Series C Financing to Accelerate Commercialization of Colovac®
Asabys joins SafeHeal’s global investor syndicate, which includes Sofinnova, Solar Eclipse and a Leading Multinational Life Sciences Corporation, bringing additional resources and strategic expertise to advance pivotal U.S. trial and commercial launch of Colovac®, SafeHeal’s breakthrough alternative to temporary stoma... Read More →
PanTher Completes First Cohort in Pancreatic Cancer Phase 1b Trial Ahead of Expectations
– Trial evaluating PTM-101, an absorbable, long-lasting, high-dose chemotherapy patch for non-metastatic pancreatic cancer – – PTM-101 administration in the 200 mg cohort has been completed without dose-limiting toxicity – – First subject enrolled in highest cohort of dose escalation... Read More →
Tasso, Inc. Joint Venture Receives Controlled Medical Device Approval in Japan for Novel Self-Administered Blood Collection Device
Certification clears path in Japan for wider access to preventive medicine, telemedicine, and reduced provider burden SEATTLE – September 9, 2025 – Tasso, Inc., the leading provider of patient-centric, clinical-grade blood collection solutions, today announced that the TS Blood Collection... Read More →