December 1, 2025 - Health Technology Insights

December 1, 2025
HealthTech Media Room
HealthTech News, News, news

Johnson & Johnson Gets EU Approval for IMAAVY to Treat Generalized MG

Nipocalimab is the first FcRn blocker approved in both adult and adolescent gMG patients aged 12 and older who are anti-AChR or anti-MuSK antibody-positive Johnson & Johnson announced that...

December 1, 2025
HealthTech Media Room
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MannKind FDA Reviews FUROSCIX Autoinjector for Edema

If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds MannKind Corporation announced that the U.S. Food and Drug Administration...

December 1, 2025
HealthTech Staff Writer
AI in Healthcare, Digital Health

The New Face of Wellness — What DNA Testing Reveals About Your Health Inheritance

Genetic intelligence is becoming a core pillar of preventive health. Organizations that act on these insights now are shaping a more personalized future for wellness. Across the U.S., people...

December 1, 2025
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HeartBeam Updates FDA Path for 12-Lead ECG Software

Company engaging in multiple options for a constructive resolution HeartBeam, Inc., a medical technology company focused on transforming cardiac care by providing powerful personalized insights, announced its regulatory strategy...

December 1, 2025
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Crux Launches No-Cost Benefit with $6.5Million Funding

Crux, the first benefits platform partnering with big pharma and employers of all sizes to expand transparent and affordable access to transformative quality-of-life (QoL) medications, announced its public launch...

December 1, 2025
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Celltrion Receives Health Canada Approval for Eydenzelt, a Biosimilar Referencing Eylea

The approval is based on the totality of evidence, including analytical, nonclinical, and clinical data from global Phase III studies demonstrating Eydenzelt is similar in efficacy and safety for...

December 1, 2025
HealthTech Media Room
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Mosaic Clinical Names Mike Peresie as President

Mosaic Clinical Technologies (Mosaic), the technology and AI services division of Radiology Partners (RP), announced the appointment of Mike Peresie as President of Mosaic. Mike joins Mosaic as a seasoned digital health executive...

December 1, 2025
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HealthTech News, news, News

GE HealthCare Debuts Next-Gen SIGNA MRI System

Both new systems, 510(k) pending at the U.S. FDA, are powered by SIGNA One, an ecosystem of AI-driven workflow solutions designed to reduce inefficiencies and support MRI exams from...

December 1, 2025
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Samsung Bioepis Launches Denosumab Biosimilars in Europe

Launch reinforces Samsung Bioepis’ biosimilar leadership in Europe as it expands its portfolio into endocrinology and builds on its growing direct sales efforts Samsung Bioepis Co., Ltd. announced the...

December 1, 2025
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L&T Technology Services Transforms Respiratory Diagnostics with NVIDIA AI-Powered Digital Twin Technology

Collaboration brings together LTTS’ expertise in MedTech and NVIDIA AI infrastructure to deliver precision diagnostics and enhance patient care L&T Technology Services, a global leader in AI, Digital & R&D...

December 1, 2025
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FDA Approves IsoPSA Cleveland Diagnostics’ Novel Blood-Based Prostate Cancer Test

IsoPSA Test Evaluates Prostate Cancer-Specific Structural Variants of the PSA Protein to Aid in the Diagnosis of High-Grade Prostate Cancer Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company,...

December 1, 2025
HealthTech Staff Writer
HealthTech News, news, News

Ronovo Surgical Adds New Non-Executive Directors

Ronovo Surgical, a global leader in next-generation surgical robotics, announced the appointment of Dr. Eduardo Parra-Davila and Jeroen M.M. van Heesewijk as Non-Executive Directors to its Board of Directors....