FDA Seeks Input on Regulatory Framework for GenAI-Enabled Medical Devices

The U.S. Food and Drug Administration issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enable...

August 20, 2026 | Thursday | News
Nanochon Receives Panama Approval to Begin First-in-Human Chondrograft Knee Study

Nanochon, a medical device company developing Chondrograft, a novel patented implant for the treatment of articular cartilage defects of the knee, announ...

August 17, 2026 | Monday | News
NeuroPace to Work with FDA After PMA Supplement for IGE Indication Receives Non-Approvable Letter

-- Company received communication from FDA indicating that the PMA Supplement for idiopathic generalized epilepsy is not approvable in its current form...

July 30, 2026 | Thursday | News
Sapphiros Secures BARDA-Backed RRPV Agreement to Advance Portable Molecular Diagnostics

Multi-year program supports development of disposable molecular diagnostic platforms for point-of-care, field-use, and emergency response settings  ...

July 16, 2026 | Thursday | News
Danaher’s Abcam Partners with EpiCypher to Advance Epigenomics Research

Abcam, a Danaher company and a global provider of validated antibodies and assay solutions, and EpiCypher®, the leading provider of ChIC/CU...

July 09, 2026 | Thursday | News
Smith+Nephew Achieves First Clinical Cases with Next-Generation CORI XT Handheld Robotics Platform

Smith+Nephew (LSE: SN, NYSE: SNN), the global medical technology company, announces the completion of the first clinical cases performed using the nextâ€...

June 10, 2026 | Wednesday | News
Cornerstone Robotics Wins EU CE Mark for Sentire® Surgical System, Expanding Into European Markets

Cornerstone Robotics ("CSR"), a leading global innovator in surgical robotics based in Hong Kong, China, is pleased to announce its Sentire® Endoscop...

May 27, 2026 | Wednesday | News
NEXTBIOMEDICAL Partners with Asahi Intecc to Commercialize Nexsphere-Fâ„¢ in Japan

NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), an innovative medical device company based in South Korea, announced that it has entered into an exclusive dis...

April 13, 2026 | Monday | News
Polyrizon Advances Clinical Pathway With CRO Agreement For Biocompatibility Studies

Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a pre-clinical-stage biotechnology company developing intranasal ad...

March 18, 2026 | Wednesday | News
Nelipak Opens Asia-Pacific Technical Development Center in Singapore to Accelerate Sterile Packaging Innovation

  Nelipak® Corporation (“Nelipak”), a leading global provider of healthcare packaging solutions, announced the opening of its new Asi...

March 13, 2026 | Friday | News
Bayer Secures FDA Clearance Expanding Capabilities of MEDRAD MRXperion MR Injection System

Clearance reinforces Bayer’s continued commitment to dependable, integrated radiology solutions Expanded Tesla compatibility captures low- to ...

March 06, 2026 | Friday | News
Applied Medical Wins $381 Million Antitrust Verdict Against Medtronic

A team from Knobbe Martens obtained a decisive win for medical device manufacturer Applied Medical against Medtronic, Inc. in an antitrust case involving...

February 11, 2026 | Wednesday | News
Peijia Medical Advances Global Expansion with EU MDR CE Mark Filing for GeminiOne TEER System

Peijia Medical Limited announced that it has formally submitted the European Union Medical Device Regulation (EU MDR) CE Mark registration application fo...

February 10, 2026 | Tuesday | News
Slingshot Biosciences Strengthens UK and EU Presence with Synthetic Cell Mimic Technology

Life sciences innovator and leader in precision-engineered synthetic cell mimic technology expands its UK/EU operations to accelerate cell and gene thera...

February 06, 2026 | Friday | News

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