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Why FDA Clearance Alone Can’t Guarantee Medical Device Success

Why FDA Clearance Alone Can’t Guarantee Medical Device Success Anonymous (not verified) Thu, 10/15/2026 - 10:12 pharmagather item url Why FDA Clearance Alo...

New Diagnostic Radiology Viewer Achieves FDA 510(k) Clearance, Setting Industry Benchmark

Candelis, Inc. has earned FDA 510(k) clearance for its ImageGrid StreamVue Enterprise platform, positioning the streaming-based software among the top-rated diagnostic radiology vi...

<![CDATA[FDA Grants Accelerated Approval to Jemperli for MSI-H/dMMR Locally Advanced Rectal Cancer]]>

Coreline Soft Receives U.S. FDA 510(k) Clearance for AVIEW Aorta Metrics, Expanding Its Chest CT AI Portfolio in the U.S...

SEOUL, South Korea and CHICAGO, Oct. 23, 2026 /PRNewswire/ — Coreline Soft has received U.S. Food and Drug Administration (FDA)…

FDA Panel Backs Galleri Multi-Cancer Early Detection Test

FDA advisory panel voted in favor of GRAIL's Galleri multi-cancer early detection test for adults 50 and older, supporting its safety and benefit-risk profile

Revolution drug heralded as a pancreatic cancer breakthrough cleared by FDA

Rasonque’s speedy approval — just a month after a completed submission — represents a paradigm shift for a notoriously deadly cancer and begins what analysts see as a highly lucrat...

FDA clears Revolution Medicines' targeted pancreatic cancer pill

REDWOOD CITY, California: The U.S. Food and Drug Administration has approved Revolution Medicines' targeted drug Rasonque for adults with metastatic pancreatic cancer who have rece...

Grail multicancer detection test wins FDA advisers’ backing

Panel members said the first-of-a-kind blood test should not be used to replace medical guideline-recommended cancer screenings, however.

Shoulder Innovations Receives FDA 510(k) Clearance for N-22 Humeral Head and Initiates Full Commercial Launch

Second Product Introduction on New Line of Technologies for Metal-Sensitive Patients GRAND RAPIDS, Mich., Sept. 10, 2026 /PRNewswire/ — Shoulder…

Kelpi seaweed-based coating secures FDA food contact clearance

UK-based Kelpi has received food contact clearance from the US Food and Drug Administration (FDA) for its seaweed-based packaging coating. The post Kelpi seaweed-based coating secu...

FDA clears path for oral fluid, hair drug tests

American Trucking Associations, which spent years pressing for the change, called the move an important step toward strengthening highway safety.

Medtronic announces FDA clearance for LigaSureâ„¢ RAS Maryland instrument on the Hugoâ„¢ RAS system

GALWAY, Ireland, Sept. 16, 2026 /PRNewswire/ — Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and…

Shoulder Innovations Receives FDA 510(k) Clearance for N-22 Humeral Head and Initiates Full Commercial Launch

Second product introduction on new line of technologies for metal-sensitive patients.

FDA OKs Lyrfigtu for previously treated bile duct cancer

The FDA approved lirafugratinib — a kinase inhibitor — for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma.The indication for lirafug...

<![CDATA[FDA Approves Welireg Plus Lenvima for Previously Treated Adult Patients With ccRCC]]>

<![CDATA[FDA Approves Tecentriq for Stage III dMMR Colon Cancer]]>

<![CDATA[Pharmaceutical Executive Daily: FDA Grants Accelerated Approval to Jemperli]]>

FDA grants 510(k) clearance for BoneEnhance, the first machine learning layer on RIVANNA’s Accuro XV platform

Anatomy segmentation and three-dimensional skeletal visualization arrive with this clearance; an injury detection module for clinical decision support…

Happy Health’s Cuffless BP Device Wins FDA Clearance

Happy Health has received FDA clearance for its wearable ring, which continuously measures blood pressure without a cuff or external calibration. The post Happy Health’s Cuffless B...

FDA Clears Tool To Help Diagnose Autism

Federal regulators are green-lighting a new tool designed to assist clinicians in identifying children with autism. The post FDA Clears Tool To Help Diagnose Autism appeared first...

RingConn smart ring receives FDA clearance for blood oxygen monitoring

Shenzhen-based wearable technology company RingConn has received US Food and Drug Administration (FDA) 510(k) clearance for non-invasive blood oxygen (SpO2) measurement on its Smar...

ZBeats Receives FDA Clearance for ZBPro Diagnostic v2.0, Supporting ECG Analysis Up to 14 Days

Expanded platform supports wearable patches across diverse recording devices; Company to showcase new capabilities at HRX 2026 in Atlanta.

DreaMed Wins FDA Clearance for CGM-Driven Insulin Automation Tool for Both Type 2 Injection Regimens

DreaMed Diabetes has received FDA 510(K) clearance for MODI, a mobile app that uses CGM (continuous glucose monitoring) data to provide insulin dosing recommendations for people wi...

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Fayuvi]]>