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FDA Approves Genio® 2.1 for Use in DREAM U.S. IDE Pivotal Study

FDA Approves Genio® 2.1 for Use in DREAM U.S. IDE Pivotal Study

Mont-Saint-Guibert, Belgium, June 1 (Korea Bizwire) – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Nyxoah’s next generation Genio® 2.1 system [...]

Philips Receives FDA 510(k) Clearance for Latest Breakthrough High-performance MR 7700 System

Philips Receives FDA 510(k) Clearance for Latest Breakthrough High-performance MR 7700 System

MR 7700 imaging system features an enhanced gradient system for unmatched performance and precision, delivering Philips’ highest image quality to help improve diagnostic outcomes Newest MR innovation from Philips integrates artificial intelligence [1] for improved workflow to enhance patient and staff experience Philips is the first to bring multi nuclei to clinical practice with seamless integration [...]

Junshi Biosciences and Coherus Receive Complete Response Letter from U.S. FDA for Toripalimab BLA

Junshi Biosciences and Coherus Receive Complete Response Letter from U.S. FDA for Toripalimab BLA

SHANGHAI, China, and REDWOOD CITY, Calif., May 2 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) announced today that the U.S. Food and Drug Administration (“FDA”, “the Agency”) has issued a complete response letter (“CRL”) for the Biologics License Application (“BLA”) for toripalimab in combination with gemcitabine and [...]

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors

SHANGHAI, China, April 3 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its anti-CD112R monoclonal [...]

Latest Release of Philips Capsule Surveillance Receives FDA Clearance

Latest Release of Philips Capsule Surveillance Receives FDA Clearance

Amsterdam, the Netherlands, March 15 (Korea Bizwire) – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, announced today at HIMSS22 that the latest Philips Capsule Surveillance solution has received 510(k) market clearance from the U.S. Food & Drug Administration (FDA), paving the way for widespread deployment across healthcare systems in the USA. Capable of utilizing streaming data [...]

Philips Collaboration Live Integrated Tele-ultrasound Expands FDA 510(k) Clearance for Remote Diagnostic Use to Additional Mobile Platforms

Philips Collaboration Live Integrated Tele-ultrasound Expands FDA 510(k) Clearance for Remote Diagnostic Use to Additional Mobile Platforms

Amsterdam, the Netherlands, March 11 (Korea Bizwire) – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that Collaboration Live has received expansion of its U.S. Food & Drug Administration 510(k) market clearance for remote diagnostic use on additional mobile platforms. Available on Philips Ultrasound Systems EPIQ and Affiniti [1], Collaboration Live allows clinicians [...]

FDA Pre-Submission Filed for Cardio inCode-SCORE

FDA Pre-Submission Filed for Cardio inCode-SCORE

OXFORD, England, Jan. 11 (Korea Bizwire) – GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces the filing of its Pre-Submission for Cardio inCode-SCORE with the Food and Drug Administration (FDA). Cardio inCode-SCORE is an in-vitro diagnostic test that assesses an individual’s combined genetic and clinical risk to predict and [...]

FDA Authorizes Marketing of 22nd Century Group’s VLN® as a Modified Risk Tobacco Product

FDA Authorizes Marketing of 22nd Century Group’s VLN® as a Modified Risk Tobacco Product

BUFFALO, N.Y., Dec. 23 (Korea Bizwire) — 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and improving health and wellness through modern plant science, announced today that the U.S. Food and Drug Administration (FDA) has authorized the marketing of the Company’s VLN® King and VLN® Menthol King reduced [...]

Philips Receives FDA De Novo Clearance for IVC Filter Removal Laser Sheath – CavaClear – with Breakthrough Device Designation

Philips Receives FDA De Novo Clearance for IVC Filter Removal Laser Sheath – CavaClear – with Breakthrough Device Designation

Philips IVC Filter Removal Laser Sheath – CavaClear – is intended to safely ablate tissue to remove embedded IVC filters CavaClear is a first-in-class FDA-cleared solution for advanced IVC filter removal It is estimated that in the United States more than one million patients with IVC filters would benefit from filter removal to reduce the [...]

FDA Approves Telix’s Prostate Cancer Imaging Product, Illuccix®

FDA Approves Telix’s Prostate Cancer Imaging Product, Illuccix®

MELBOURNE, Australia and INDIANAPOLIS, Dec. 20 (Korea Bizwire) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company), a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on molecularly targeted radiation (MTR), today announces that the United States Food and Drug Administration (FDA) has approved Telix’s lead prostate cancer imaging product, Illuccix®. [...]