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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...

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…

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.

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.

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

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.

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...

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

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...

MRI2CT Receives FDA 510(k) Clearance for NextMR, Enabling 3D Bone Visualization from Standard Spine MRI

FDA clearance advances MRI-only spine workflows using the patient’s standard diagnostic MRI.

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)…

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

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…

<![CDATA[FDA Approves Subcutaneous Induction for Skyrizi in Crohn's Disease]]>

FDA panel supports multicancer early detection test

An FDA advisory panel expressed support for a blood test designed to detect early signs of multiple cancers, including some for which no screening alternative exists.Members of the...

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 green lights Priovant drug for rare skin disease

Lisraya’s clearance marks the first approval of a drug the Roivant subsidiary licensed from Pfizer and has since positioned against multiple rare inflammatory conditions.

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...

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…

FDA approves prodisc C Nova device for two-level use

Centinel Spine LLC announced it has received FDA approval for two-level use of the prodisc C Nova cervical total disc replacement device, according to a company press release.In cl...

SI-BONE Receives FDA 510(k) Clearance for iFuse Granite Onyxâ„¢, Extending Its Compromised Bone Franchise Beyond the Pel...

SI-BONE, Inc. announced FDA 510(k) clearance for the iFuse Granite Onyx System (Onyx).

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...

Dutch Medical Device Maker, Medical Precision, Enters U.S. Market With FDA-Cleared Comfort Marker

Radiotherapy patient-marking device, engineered with technology from the permanent make-up industry, will make its U.S. clinical debut at…