Latest updates for Fda Clearance
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Recent items include:
- <![CDATA[FDA Clears Consano’s IND for C-1101 ]]>
- Candelis Announces FDA 510(k) Clearance for ImageGrid® StreamVue™ Enterprise Diagnostic Streaming Viewer
- FDA Eases Approval Path for Certain Cancer Companion Diagnostic Tests
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Candelis Announces FDA 510(k) Clearance for ImageGrid® StreamVue™ Enterprise Diagnostic Streaming Viewer
Delivering premium diagnostic performance from any location without the cost and disruption of traditional enterprise viewing platforms. NEW YORK, July 30, 2026 /PRNewswire-PRWeb/...
FDA Eases Approval Path for Certain Cancer Companion Diagnostic Tests
The U.S. Food and Drug Administration has issued a final order moving certain laboratory tests used to help guide treatment with approved cancer drugs from...
Implantica finally nabs FDA approval 8 years after EU green light for reflux implant
The FDA has signed off on Implantica’s gastroesophageal reflux disease (GERD) implant as the medtech eyes a lucrative U.S. market.
FDA approves Freenome colorectal cancer blood test to be marketed by Abbott
The FDA has approved Freenome’s new blood-based colorectal cancer test, SimpleScreen CRC, which Abbott will exclusively market in the U.S.
<![CDATA[Pharmaceutical Executive Daily: FDA Grants Traditional Approval to Novartis's Fabhalta]]>
MAMMOMAT B.brilliant Contrast-Enhanced Mammography Cleared by the FDA
• Improved image reconstruction supports diagnosis even in dense breast tissue• Contrast-enhanced biopsy boosts diagnostic confidence• Features build on system's ability to create...
SurGenTec® Secures FDA Clearance for ION-L™ – Lumbar Navigation Compatible
SurGenTecВ® announced that the FDA has granted 510(k) clearance for its ION-Lв„ў navigation instruments for use with the ION-Lв„ў Lumbar Facet Fixation System.
<![CDATA[FDA Approves Fabhalta to Slow Kidney Function Decline in Primary IgAN in Adults ]]>
3D Systems Enables First FDA Clearance for Implant from a Point-of-Care Institution
- Collaboration with Defense Health Agency (DHA) enables Walter Reed 3D Medical Application Center (3D MAC) to achieve first FDA-cleared medical device - First-ever FDA clearance...
FDA extends review of Capricor cell therapy; Pain drug startup to go public
The agency is now reviewing an updated application for deramiocel with a “refined” indication. Elsewhere, a startup co-founded by Vivek Ramaswamy is taking a speedy path to the pub...
Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test
Roche and Eli Lilly have won FDA clearance for their latest Alzheimer’s disease diagnostic.
FDA clears Lantheus’ Alzheimer’s PET imaging agent Tauklarify
Lantheus, which recently agreed to an $8 billion takeover by fellow radiopharma Curium, garnered FDA clearance for its Alzheimer’s PET imaging agent Tauklarify.
Samsung hearing aid features for its ear buds garner FDA clearance
The FDA gave Samsung Electronics the go-ahead for the latest software features that allow its Galaxy Buds earphones to act as an OTC hearing aid that also allows users to diagnose...
FDA greenlights Abbott’s wearable sensor for capturing diabetic ketoacidosis
The FDA has approved Abbott’s first-of-its-kind bio-wearable sensor that can warn diabetics of increased ketones that can lead to diabetic ketoacidosis.
<![CDATA[Pharmaceutical Executive Daily: FDA Approves Subcutaneous Formulation of Leqembi Iqlik]]>
Merck wins first approval of a PCSK9 cholesterol pill
The speedy clearance of Lipfendra is an important milestone for Merck and the result of a controversial voucher program put in place by former FDA commissioner Marty Makary.
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.
<![CDATA[Pharmaceutical Executive Daily: FDA Approves Orezeyful]]>
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...
<![CDATA[FDA Approves Leqembi Iqlik Subcutaneous Injection for Early Alzheimer’s Disease]]>
GMReis Receives FDA 510(k) Clearance for the VersaLock® Sterile Plating System, Advancing Its Single-Use Trauma Strategy...
GMReis has received FDA 510(k) clearance K262537 for the VersaLock® Sterile Plating System, completing 510(k)-cleared sterile implant solutions across its upper and lower extremity...
FDA approves blood-based SimpleScreen CRC test for colorectal cancer surveillance
The FDA has approved a second blood-based colorectal cancer screening option for adults aged 45 years and older at average risk for the disease.SimpleScreen CRC (Freenome) is a non...
Replimune rebounds to win FDA approval of melanoma drug
The accelerated clearance follows two earlier rejections and the support of an advisory panel that disputed the arguments of FDA scientists.
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