Social Media Ideas for Fda Breakthrough Device

Nutromics Nabs FDA Breakthrough Status for Antibiotic Monitoring Patch

Nutromics earned FDA breakthrough device designation for its wearable patch that tracks vancomycin levels in real time. The device aims to replace the periodic blood draws currentl...

VB Spine Announces FDA Breakthrough Device Designation for New Blood Test Designed to Identify Patients at Risk for Scol...

VB Spine LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to ScolimiR-3D.

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.

FDA launches pilot program to speed up early US drug research

First teased in June and formally announced Tuesday as part of “Operation Trialblazer,” the program will partner drugmakers with research institutions to more quickly bring medicin...

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 approves breakthrough cancer drug months ahead of schedule: ‘Unprecedented results’

The FDA approved the medication more than six months ahead of schedule after trials showed it nearly doubled median survival to 13.2 months versus 6.7 months with chemotherapy.

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

VB Spine Announces FDA Breakthrough Device Designation for New Blood Test Designed to Identify Patients at Risk for Scol...

ScolimiR-3D, a novel microRNA-based blood test, is designed to enable earlier intervention and personalized management of adolescent idiopathic…

<![CDATA[FDA Launches Rare Disease Framework Initiative ]]>

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...

FDA approves breakthrough drug to treat advanced pancreatic cancer

The Food and Drug Administration (FDA) approved on Wednesday a drug that could extend the survival of those with metastatic pancreatic cancer.

CorTec receives second FDA ‘Breakthrough Device’ designation for its brain computer interface

CorTec has received a second US Food and Drug Administration Breakthrough Device Designation for its Brain Interchange brain-computer interface, this time covering communication fo...

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

SELUTION SLR™ wins historic US FDA nod for in‑stent restenosis

SELUTION SLR™ wins historic US FDA nod for in‑stent restenosis The US Food and Drug Administration has approved the SELUTION SLR™ (Sustained Limus Release) Drug-Eluting Bal...

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

FDA Opens Applications for New Pilot to Shorten Drug Approval Times: What Sponsors Need to Know

Earlier this month, FDA opened applications for a new Expedited Investigational New Drug (IND) Pilot Program (the “Program”), an initiative launched under HHS Operation TrialBlazer...

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).

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...

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

FDA Breakthrough Device Designated (BDD) platform engineered for durable fixation in low density bone SANTA CLARA, Calif., Sept.…

FDA panel endorses first-of-a-kind cancer blood test

Federal health advisers endorsed an experimental blood test designed to spot signs of various cancers in apparently healthy people. Here's how the technology works.

FDA approves 'breakthrough' Parkinson's treatment led by Cleveland Clinic doctor

On Monday, Sept. 28, the U.S. Food and Drug Administration approved a new treatment that targets dopamine pathways critical to those living with the disease.

FDA Medical Devices: Important Regulatory Considerations for Companies Seeking to Enter the U.S. Market

The medical device market in the U.S. is very large and attractive to many companies who are located outside of the U.S. Entering the U.S. medical device market requires a comprehe...

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…

FDA panel endorses first-of-a-kind cancer blood test

Federal health advisers on Wednesday endorsed a blood test designed to spot signs of various cancers in apparently healthy people while warning that it’s far from clear how well th...