KROGER HEALTH: Receives FDA Emergency Use Authorization for its COVID-19 Test Home Collection Kit
Kroger Health's new testing model combines at-home convenience with telehealth technology, with most results confirmed in less than 72 hours
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ENGAGE SURGICAL: Announces FDA 510(k) Clearance And Limited Market Release Of The Cementless Engage™ Partial Knee System
Engage Surgical, a privately held orthopedic implant company, announces FDA 510(k) clearance of the only cementless partial knee system available in the USA.
CARAG: Receives U.S. FDA IDE Approval to Conduct Clinical Study of First Transcatheter Septal Occluder With Bioresorbable, Metal-free Framework
The U.S. trial for CE-marked CBSO is designed to enroll up to 250 patients in a staged study approach
LIVSMED: Receives FDA 510(k) Clearance for ArtiSential™ Articulating Energy Laparoscopic Instruments
LivsMed Inc. receives 510(k) clearance from the FDA for its ArtiSential™ articulating bipolar energy instruments for electrosurgical cutting and coagulation. ArtiSential™ devices feature the patented, double-jointed end effector, which allows surgeons to overcome the challenges presented by difficult angles of approach, especially in complex procedures.
FDA: Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
The U.S. Food and Drug Administration took important action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure.
ENVOY MEDICAL: Receives FDA Breakthrough Device Designation for its Fully Implanted Acclaim® Cochlear Implant
Also Celebrates 10-Year Anniversary of Invisible Hearing with Esteem® FDA Approval
LUMINEX: Submits Emergency Use Authorization Request to U.S. FDA for COVID-19 Antibody Test
Assay uses multiplexing for highly specific and sensitive detection of IgG antibodies against SARS-CoV-2
BIOVENTUS: Receives FDA Clearance of Strip Format of its SIGNAFUSE® Bioactive Bone Graft
Bioventus, a global leader in orthobiologic solutions, is launching its SIGNAFUSE Bioactive Bone Graft in a new strip format.
CIRCADIA HEALTH: Announces FDA Clearance of the C100 System for Contactless Respiratory Monitoring
Circadia Health announced today that it has received expedited FDA clearance for Contactless Respiration Rate (CResp®) monitoring due to COVID-19.
COMPANION MEDICAL: InPen Receives FDA Clearance for Expanded Pediatric Use
Companion Medical, manufacturers of InPen, the only FDA-cleared smart insulin pen system, announced that they received FDA expanded clearance for all ages* to use the InPen System.
VIRALITY DIAGNOSTICS: Antibody Test Wins FDA EUA
The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a rapid COVID-19 antibody test distributed by Virality Diagnostics LLC, manufactured by Biohit (Hefei).
GENCURIX: Wins FDA EUA for COVID-19 Test Kit
Enhanced performance and high throughput screening up to 384 samples simultaneously
AIR QUEEN: Quickly Moves to Supply Its 510K FDA Approved N95 Equivalent Surgical Grade Nano-fibre Mask into North America to Help Protect First Responders, Workers and Families from COVID-19
Since the sudden onset of the COVID-19 pandemic the United States has faced a supply constraint of quality N95 masks.
ABBVIE: Allergan, an AbbVie Company, and Molecular Partners Receive Complete Response Letter from FDA on Biologics License Application for Abicipar pegol
Allergan, an AbbVie Company (NYSE: ABBV), and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application (BLA) for Abicipar pegol, a novel, investigational DARPin® therapy for patients with neovascular (wet) age-related macular degeneration (nAMD).
FDA: Coronavirus (COVID-19) Update: Joint Statement from USDA and FDA on Food Export Restrictions Pertaining to COVID-19
U.S. Secretary of Agriculture Sonny Perdue and FDA Commissioner Stephen M. Hahn, M.D., issued the following statement regarding food export restrictions pertaining to COVID-19
MEDAKIT LTD: Responds to FDA Warning Letter
Medakit Ltd, a leading biotech company specialized in the production of antibody diagnosis tests for COVID-19, received on June 10th a warning letter from the Food and Drug Administration outlining their concern regarding the terminology utilized in Medakit website allegedly suggesting the use of Medakit test for "home-use" settings.
FDA: Coronavirus (COVID-19) Update: FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts
U.S. Food and Drug Administration has taken an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency.
CLEW: Receives FDA Emergency Use Authorization (EUA) for Its Predictive Analytics Platform in Support of COVID-19 Patients
CLEWICU is the only device authorized by the FDA to provide early identification of patients who are likely to experience respiratory failure or hemodynamic instability, both potentially common but significant complications associated with COVID-19
FDA: Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts
U.S. Food and Drug Administration has taken an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency.
TSS: Technical Safety Services Authorized by FDA to Decontaminate N95 Respirators
TSS is ready to decontaminate masks immediately.