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Winter Innovations Receives FDA 510(k) Clearance and PCCP Authorization for Expanded EasyWhip® Family

Winter Innovations announced that the FDA has granted 510(k) clearance for the expanded EasyWhip® Family, along with authorization of a Predetermined Change Control Plan (PCCP) cov...

<![CDATA[FDA Sends CRL to Cingulate for CTx-1301]]>

HepQuant nabs FDA premarket approval for liver diagnostic test

The FDA has granted premarket approval to HepQuant’s liver diagnostic test for the treatment of adults with Child-Pugh Class A compensated cirrhosis, according to a company press r...

Orthopedic Driven Imaging Announces FDA 510(k) Clearance for HipGuide™ — Its First FDA-Cleared Surgical Imaging App

IHealthScreen nabs FDA nod for AI-backed dx to spot mild diabetic retinopathy

IHealthScreen hauled in FDA 510(k) clearance for its AI-powered diagnostic that detects mild diabetic retinopathy in diabetic adults who have gone undiagnosed with the condition.

FDA clears Dexcom’s Stelo OTC glucose monitor for use with children

The FDA gave the green light to Dexcom’s over-the-counter glucose monitor Stelo for children 2 years or older who don’t use insulin.

FDA Issues Draft Guidance Clarifying Use of Form FDA 3542

Next-Generation AI-Driven SyncAR® Spine Receives FDA Clearance for Spine Surgery

CLEVELAND, Oct. 10, 2025 /PRNewswire/ — Surgical Theater, the leader in surgical XR visualization, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for Sync...

Orthopedic Driven Imaging Announces FDA 510(k) Clearance for HipGuide™ — Its First FDA-Cleared Surgical Imaging App

Orthopedic Driven Imaging (ODI) announced that HipGuideâ„¢, its intraoperative surgical imaging software application, has received 510(k) clearance from the FDA.

SurGenTec Secures FDA Clearance for ION-C™ – Now Navigation Compatible

SurGenTec, LLC today announced that the FDA has granted 510(k) clearance for its ION-Câ„¢ navigation instruments for use with the ION-Câ„¢ posterior cervical facet fixation implant...

NovoSource Receives FDA Clearance for SteriKneeâ„¢ Single-Use Total Knee Instrument System

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

<![CDATA[FDA Clears Trodelvy for First-Line Metastatic Triple-Negative Breast Cancer]]>

<![CDATA[FDA Clears Every-8-Week Lebrikizumab Maintenance Dosing in Atopic Dermatitis]]>

FDA Agreement Clears Regulatory Path for Viaskin Peanut Patch

DBV Technologies will submit its Viaskin Peanut FDA application in late 2026 after agreeing to include additional safety data. The post FDA Agreement Clears Regulatory Path for Via...

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

SurGenTec Secures FDA Clearance for ION-C™ – Now Navigation Compatible

SurGenTec, LLC today announced that the FDA has granted 510(k) clearance for its ION-Câ„¢ navigation instruments for use with the ION-Câ„¢ posterior cervical facet fixation implant...

<![CDATA[Pharmaceutical Executive Daily: FDA Sends Complete Response Letter for Cingulate's CTx-1301]]>

OrthAlign, Inc. Receives FDA 510(k) clearance for the LanternВ® ASC system

IRVINE, Calif.,В June 3, 2026В /PRNewswire/ —В OrthAlign, Inc., the pioneer of handheld orthopedic navigation, today announced FDA 510(k) clearance for…

United Therapeutics nabs FDA approval for donor-lung assessment device

United Therapeutics has been given a premarket approval from the FDA for its LungFX device.

SurGenTec® Receives FDA Clearance for ION-L™, a Novel Lumbar Facet Fixation System Representing a Paradigm Shift in M...

SurGenTec® today announced FDA clearance of its ION-L™ Lumbar Facet Fixation System. ION-L™, indicated for the treatment of patients with (DDD) from L3 to S1 in skeletally mat...

<![CDATA[Pharmaceutical Executive Daily: FDA Clears Trodelvy for First-Line Metastatic Triple-Negative Breast Cancer]...

<![CDATA[FDA Accepts NDA for Giredestrant in ER-Positive Early-Stage Breast Cancer]]>

NovoSource Receives FDA Clearance for SteriKneeâ„¢ Single-Use Total Knee Instrument System

NovoSource announced that it has received FDA 510(k) clearance for SteriKneeâ„¢, a sterile, pre-assembled, single-use instrument system designed for use with the NovoKnee Total Kne...