Latest updates for Fda Clearance

Fresh curated links around FDA clearance are collected here so marketers can spot useful updates and turn timely ideas into posts faster.

Recent items include:

  • <![CDATA[FDA Clears Consano’s IND for C-1101 ]]>
  • Candelis Announces FDA 510(k) Clearance for ImageGrid® StreamVueâ„¢ Enterprise Diagnostic Streaming Viewer
  • FDA Eases Approval Path for Certain Cancer Companion Diagnostic Tests

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Fresh articles and ideas

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pharmexec.com /1 month ago

&lt;![CDATA[FDA Clears Consano’s IND for C-1101 ]]&gt;

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prweb.com /1 month ago

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/...

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savingadvice.com /3 weeks ago

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...

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fiercebiotech.com /2 weeks ago

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.

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fiercebiotech.com /1 month ago

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.

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pharmexec.com /1 month ago

&lt;![CDATA[Pharmaceutical Executive Daily: FDA Grants Traditional Approval to Novartis's Fabhalta]]&gt;

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cassling.com /2 weeks ago

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...

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orthotw.com /1 month ago

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.

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pharmexec.com /1 month ago

&lt;![CDATA[FDA Approves Fabhalta to Slow Kidney Function Decline in Primary IgAN in Adults ]]&gt;

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orthotw.com /1 month ago

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...

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biopharmadive.com /2 weeks ago

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...

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fiercebiotech.com /2 weeks ago

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.

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fiercebiotech.com /3 weeks ago

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.

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fiercebiotech.com /4 weeks ago

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...

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fiercebiotech.com /2 weeks ago

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.

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pharmexec.com /1 month ago

&lt;![CDATA[Pharmaceutical Executive Daily: FDA Approves Subcutaneous Formulation of Leqembi Iqlik]]&gt;

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biopharmadive.com /1 month ago

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.  

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biopharmadive.com /1 week ago

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.

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pharmexec.com /1 month ago

&lt;![CDATA[Pharmaceutical Executive Daily: FDA Approves Orezeyful]]&gt;

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biopharmadive.com /2 weeks ago

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...

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pharmexec.com /1 month ago

&lt;![CDATA[FDA Approves Leqembi Iqlik Subcutaneous Injection for Early Alzheimer’s Disease]]&gt;

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orthotw.com /2 weeks ago

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...

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healio.com /1 month ago

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...

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biopharmadive.com /1 month ago

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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biopharmadive.com

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cassling.com

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fiercebiotech.com

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healio.com

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pharmexec.com

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