Aevice Health Secures US FDA Clearance for Pediatric Use of AeviceMD, a Remote Respiratory Monitoring Platform Enabled by Smart Wearable Stethoscope
Singapore, 19 May 2025 — Aevice Health, a MedTech company pioneering remote respiratory monitoring solutions, announced today that its flagship medical device, the AeviceMD, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in pediatric patients aged... Read More →
UK’s Huma expands US Presence with Aluna acquisition, launches M&A partnership with Eckuity Capital
The company has become a partner to national health initiatives in the UK, U.S., Germany, Saudi Arabia and Greece. London-based healthtech unicorn Huma is accelerating its growth by acquiring US respiratory health startup Aluna, and a new strategic partnership with... Read More →
CoapTech Receives 510(k) Approval for its PUMA-G Pediatric device!
May, 2025 — The PUMA-G Pediatric device is now cleared by the U.S. FDA for use in children. This device will enable an ultrasound-based gastrostomy procedure for kids, with the potential to reduce radiation, sedation, procedure time, scarring, and infections... Read More →
Prevencio Receives FDA Breakthrough Device Designation for HART CADhs, Its Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease
KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc., the leader in artificial intelligence-powered blood tests for cardiovascular diagnostics, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its HART CADhs® test. This designation recognizes HART CADhs as an... Read More →
Pluto Bio Raises $3.6M to Expand AI-Powered Multi-Omics Analysis Platform for Pharma
Funding led by new investor Kickstart, with continued support from Silverton Partners and other investors DENVER–(BUSINESS WIRE)–Pluto Bio, the leading, AI-powered platform for computational biology, today announced it has raised $3.6 million in new funding to accelerate growth and scale... Read More →
GE HealthCare and Raydiant Oximetry accelerate innovation in fetal oxygen saturation technology
The companies plan to co-develop solutions that support the integration of Raydiant Oximetry’s fetal pulse oximetry technology into GE HealthCare’s fetal monitoring and digital perinatal surveillance platforms that have a 60-year history of innovation and industry firsts. Fetal pulse oximetry... Read More →
FDA Approves Teal Health’s Teal Wand™—The First and Only At-Home Self-Collection Device for Cervical Cancer Screening, Introducing a Comfortable Alternative to In-Person Screening
Women can now collect their own sample from the privacy of home, no speculum required, and mail it to a certified lab to be tested on the same test as the doctor’s office, with the same accuracy. San Francisco, CA... Read More →
AccurKardia’s AccurECG Named “Best New Technology Solution for ECG” in 9th Annual MedTech Breakthrough Awards Program
Prestigious International Annual Awards Program Recognizes Standout Digital Health & Medical Technology Products and Companies NEW YORK–(BUSINESS WIRE)–AccurKardia, an innovator in ECG-based diagnostics technology, today announced that its AccurECGTM software platform has been selected as winner of the “Best New... Read More →
PATH EX, Inc. Announces Successful $5 Million Financing Round to Advance CycloPE(R), a Breakthrough Treatment for Sepsis
HOUSTON, TEXAS / ACCESS Newswire / May 8, 2025 / PATH EX, Inc., a medical device company located in the Texas Medical Center Innovation Factory, is excited to announce the successful completion of a $5 million financing round. This investment... Read More →
Bobby Reddy Jr from Presnosis makes TIME’s 100 list
Every year in the U.S., about 6% of emergency room visits are due to sepsis, an extreme immune system reaction to infection that can lead to organ failure and death in a short period of time. Anywhere from 30% to... Read More →