GE HealthCare Advances CT Innovation with 510(k) Submission for Photonova™ Spectra Photon-Counting System

GE HealthCare announced the submission of a 510(k) to the U.S. FDA seeking clearance for Photonova™ Spectra, its new photon-counting computed ...

November 25, 2025 | Tuesday | Regulatory
Teijin and BioVaram Form Strategic Alliance to Advance Regenerative Medicine and Implantable Devices Between Japan and India

Teijin Limited and BioVaram, the brand name of the UR Advanced Therapeutics Pvt Ltd. (URAT), announced that they have signed a business alliance agreement ...

November 14, 2025 | Friday | News
Thermo Fisher Secures FDA Clearance for First-of-Its-Kind Automated System to Transform Multiple Myeloma Diagnosis

First-of-its-kind, automated system delivers increased sensitivity, specific identification of disease markers and improved laboratory workflow to suppor...

November 13, 2025 | Thursday | Regulatory
Protaryx Medical Submits 510(k) Application to FDA for Novel Transseptal Puncture Device

Protaryx Medical, an innovative medical device company developing disruptive access solutions for minimally invasive left-heart procedures, announced tha...

October 27, 2025 | Monday | News
Aesculap Launches New Irrigating Specialty Non-Stick Disposable Bipolar Forceps in the U.S.

Aesculap, Inc., a leader in surgical innovation, announced the launch of its new Irrigating Specialty Non-Stick Disposable Bipolar Forceps to the U.S. ma...

October 21, 2025 | Tuesday | News
KARL STORZ Receives FDA Clearance for ENDOFLATOR™ +, the Next Generation in Surgical Insufflation and Smoke Evacuation

KARL STORZ, a global leader in minimally invasive surgical technology, is proud to announce it has received U.S. Food and Drug Administration (FDA) clear...

October 06, 2025 | Monday | News
Freudenberg Medical Invests $25M to Expand Costa Rica Operations, Quadrupling Catheter Manufacturing Capacity

$25 million investment to meet growing global demand for medical devices and precision components. Expansion to quadruple manufacturing footprint for hi...

September 26, 2025 | Friday | News
AVITA Medical Secures CE Mark for RECELL® GO, Expanding European Access to Innovative Burn Care

- AVITA Medical, Inc., a leading therapeutic acute wound care company,announced it has received the CE Mark under the European Union Medical Device Regul...

September 15, 2025 | Monday | News
uLab Systems and Biolux Technology Forge Strategic Partnership to Redefine Clear Aligner Therapy

uLab Systems®, a leader in digital orthodontic innovation, and Biolux Technology, creator of the OrthoPulse® near-infrared (NIR) light therapy de...

September 12, 2025 | Friday | News
New Jersey: A Leading Life Sciences Manufacturing Hub

New Jersey at a Glance – Often dubbed the “Medicine Chest of the World,” New Jersey has a rich legacy and a dynamic present as a global h...

September 03, 2025 | Wednesday | Reports
Align Technology Files Global Patent Infringement Lawsuits Against Angelalign

Align Technology, Inc. (“Align”) (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign...

August 19, 2025 | Tuesday | News
Simpson Interventions Treats First Patients in Pivotal Trial of Acolyte™ Image-Guided Catheter for Complex Coronary Blockages

Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, announced that its groundbrea...

August 15, 2025 | Friday | News
Philips Commits $150M+ to U.S. Manufacturing and R&D, Expanding AI-Enabled Healthcare Capabilities

    Philips, a global leader in health technology,announced a plan for new investments of more than USD 150 million in U.S. manufacturi...

August 15, 2025 | Friday | News
Dräger’s Atlan A350/A350XL Anesthesia Workstations Achieve U.S. DoD ATO Certification for Maximum Patient Data Security

Certification ensures highest level of patient data security a medical device can attain Effective 7/14/2025 and expiring on 7/14/2028 under eMASS ...

August 12, 2025 | Tuesday | News

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