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FDA
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Sutter Health Expands Use of Wearable Ultrasound Tech Across Additional Bay Area Hospitals to Advance Sepsis Care

LOS ANGELES--(BUSINESS WIRE)--Sutter Health is expanding the use of FloPatch, the first wireless, wearable Doppler ultrasound device, across three additional Northern California hospitals: Sutter Solano Medical Center in Vallejo, Sutter’s Mills-Peninsula Medical Center in Burlingame and the Berkeley campus of Sutter’s Alta Bates Summit Medical Center, as part of its ongoing effort to enhance personalized intravenous (IV) fluid management for patients with sepsis and other life-threatening condi...
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Routine FDA Inspection Completed Successfully With No Findings for Clinilabs

EATONTOWN, N.J.--(BUSINESS WIRE)--Clinilabs (“Clinilabs LLC”), a global, full-service contract research organization (CRO) specializing in CNS drug and device development, today announced it has successfully completed an inspection by the U.S. Food and Drug Administration (FDA) with no observations. This outcome underscores Clinilabs continued commitment to the highest standards of regulatory compliance, operational excellence, and patient safety across its clinical research programs. “Each FDA...
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Atia Vision Announces Durable 36-Month Results from First-in-Human Study of their Dynamic Shape-Changing OmniVu Intraocular Lens System

CAMPBELL, Calif.--(BUSINESS WIRE)--Atia Vision Announces Durable 36-Month Results from First-in-Human Study of their Dynamic Shape-Changing OmniVu Intraocular Lens System...
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AtriCure to Announce First Quarter 2026 Financial Results

MASON, Ohio--(BUSINESS WIRE)--AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced that it will release its first quarter 2026 financial results on Tuesday, May 5, 2026. AtriCure will host an audio webcast at 4:30 p.m. Eastern Time on Tuesday, May 5, 2026, to discuss its first quarter financial results. Those interested in listening to th...
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U.S. FDA Grants RMAT Designation to GS-100, Grace Science’s Gene Therapy to Treat NGLY1 Deficiency

MENLO PARK, Calif.--(BUSINESS WIRE)--Grace Science, LLC, a biotechnology company founded to develop novel therapies based on the function of NGLY1, announced today that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to GS-100 for the treatment of NGLY1 Deficiency. GS-100 is an investigational AAV9 gene replacement therapy in clinical development to treat NGLY1 Deficiency, an ultra-rare genetic disease with no approved therapy. T...
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4D Path Announces Collaboration with Daiichi Sankyo to Advance AI-Driven Predictive Biomarkers for an Antibody Drug Conjugate Program

NEWTON, Mass.--(BUSINESS WIRE)--4D Path Announces Collaboration with Daiichi Sankyo to Advance AI-Driven Predictive Biomarkers for an Antibody Drug Conjugate Program...
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ELRIG Announces Inaugural US Drug Discovery Conference

CAMBRIDGE, England--(BUSINESS WIRE)--ELRIG announces Drug Discovery USA 2026. The inaugural event takes place at Pfizer in Cambridge, MA from 16–17 June and is free to attend....
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Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the First and Only Approved Medicine for FSGS

SAN DIEGO--(BUSINESS WIRE)--U.S. FDA approves FILSPARI (sparsentan) for FSGS...
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Reflow Medical Announces 12-Month Results from DEEPER REVEAL Trial: Sustained Outcomes with the Spur® Stent System in CLTI

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--DEEPER REVEAL clinical trial (NCT05358353) 12-month results evaluating the Spur Stent were presented at the SIR 2026 Annual Scientific Meeting....
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Protaryx Medical Receives FDA 510(k) Clearance for Its Breakthrough Transseptal Puncture Device

BALTIMORE--(BUSINESS WIRE)--Protaryx Medical Receives FDA 510(k) Clearance for Its Breakthrough Transseptal Puncture Device...