FDA Approves First Non-Injection Epinephrine Nasal Spray, Neffy, for Life-Threatening Allergic Reactions

U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those th...

August 12, 2024 | Monday | News
Cambridge Biotherapies™ Launches Groundbreaking Spravato™ Nasal Spray Therapy in Beverly

Cambridge Biotherapies™, a leader in advanced mental health treatments, proudly announces the introduction of Spravato™ (esketamine) nasal sp...

August 05, 2024 | Monday | News
CooperCompanies Acquires obp Surgical for $100 Million, Expanding Surgical Device Portfolio

CooperCompanies announced that CooperSurgical has acquired obp Surgical, a U.S.-based medical device company with a suite of single-use cordless surgical...

August 02, 2024 | Friday | News
Varian Receives FDA Clearance for Enhanced Ethos 2.0 Therapy System, Streamlining Adaptive Radiotherapy

Varian, a Siemens Healthineers company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new functionality to its ...

July 23, 2024 | Tuesday | News
Cepheid Secures FDA Authorization and CLIA Waiver for Revolutionary Xpert® HCV Test

Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for ...

June 28, 2024 | Friday | News
Danish MedTech Company °MEQU Secures FDA Clearance for Portable Blood and IV Fluid Warmer

Danish MedTech company, °MEQU announces 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) of the °M Warmer System - a ...

June 10, 2024 | Monday | News
Asensus Surgical to be Acquired by KARL STORZ in $300 Million Deal

Asensus Surgical, , a global leader of innovative digital solutions for the operating room, today announced that it has entered into a definitive merger ...

June 10, 2024 | Monday | News
ASP Japan Secures Exclusive Sales Contract with PENTAX Medical for Innovative Endoscopy Solutions

ASP Japan LLC (hereinafter referred to as ASP Japan) was announced by HOYA Group PENTAX Europe GmbH ( hereinafter referred to as PENTAX Medical) and the ...

May 31, 2024 | Friday | News
Stryker Introduces Gamma4 Hip Fracture Nailing System in Europe, Transforming Surgical Treatment

Stryker a global leader in medical technologies, announced that the first surgeries using the Gamma4 Hip Fracture Nailing System in Europe were completed...

May 29, 2024 | Wednesday | News
Roche and Amgen's New Lp(a) Test Receives FDA Breakthrough Device Designation

Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial inf...

May 22, 2024 | Wednesday | News
Atraverse Medical's HOTWIRE™ RF Guidewire Receives FDA Clearance, Revolutionizing Left-Heart Access

Atraverse Medical, a San Diego-based medical device company, announces the FDA clearance of its HOTWIRE™ radiofrequency (RF) guidewire, a novel devic...

May 15, 2024 | Wednesday | News
ArcScan's Insight® 100 Granted NMPA Approval in China, Offering Advanced Solution for Myopia Treatment

ArcScan, Inc., a global medical technology company dedicated to helping ophthalmologists improve vision with ultra-high frequency ultrasound diagnostic ima...

May 13, 2024 | Monday | News
GE HealthCare Launches Voluson Signature 20 and 18 Ultrasound Systems Revolutionizing Women's Health Diagnosis

GE HealthCare announced the launch of the Voluson Signature 20 and 18 ultrasound systems, which comprehensively integrate artificial intelligence (AI), adv...

April 18, 2024 | Thursday | News
 GE HealthCare Secures FDA 510(k) Clearance for IONIC Health’s nCommand Lite System to Alleviate Radiology Staffing Shortages

  GE HealthCare (Nasdaq: GEHC) announces the U.S. FDA 510(k) Clearance of IONIC Health’s revolutionary nCommand Lite technology, aimed at mitig...

March 26, 2024 | Tuesday | News

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