Thursday, April 25, 2024

Thursday, April 25, 2024

Latest News

M SQUARED ASSOCIATES: Providing Pro Bono Consulting Services to Expedite COVID19-Related FDA Applications for Critical Medical Supplies

FDA has declared the COVID-19 outbreak a public health emergency and implemented an expedited pathway to market authorization for products crucial in addressing this crisis, the Emergency Use Authorization (EUA).

FDA: Expedites approval of Cochlear's Remote Check solution for cochlear implants

Amid COVID-19 pandemic, remote healthcare solutions are a priority now more than ever

MBIO: To Seek FDA Approval for LightDeck® Platform

Future Use in Outbreak Management Expected, via DARPA Partnership

HALO LABS: Raises $12M in Series B1 Financing Round and Enters into the FDA Market

Halo Labs, a life science instrumentation company developing tools for biologics researchers, announced it has closed a $12M Series B1 financing round led by Research Corporation Technologies (RCT).

CO-DIAGNOSTICS, INC: Receives FDA Emergency Use Authorization for COVID-19 Test

Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that its Logix Smart™ Coronavirus COVID-19 Test has obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2.

FDA: Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products

During this COVID-19 pandemic, the FDA is working around the clock to make sure that Americans have access to safe food and medical products.

FDA: Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients

The U.S. Food and Drug Administration took action to help increase the supply of ventilators, ventilator tubing connectors, and ventilator accessories, as well as filtering facepiece respirators (FFRs) due to shortages during COVID-19, as part of our commitment to ease burdens on the health care system during this pandemic.

MCRA: Launches Medical Device U.S. FDA Regulatory & Clinical Trial Advisory Support & Call Center to Assist with the COVID-19 Pandemic

MCRA, LLC, a leading medical device advisory firm and CRO with specialization in regulatory affairs, clinical research, reimbursement, compliance, and quality assurance, has implemented a call center to keep medical device manufacturers informed of government and site decisions that impact regulatory submissions, clinical study operations, or quality systems as a result of the COVID-19 pandemic.

MESA BIOTECH: Receives Emergency Use Authorization from FDA for a 30 Minute Point of Care Molecular COVID-19 Test

Easy to use, palm-sized system will enable broader use across healthcare facilities closer to the patients and will begin shipping immediately

NEXVOO: The NEXVOO® factory operates as a Healthcare Certified Factory in Xiamen, China with a direct sourcing partnership to ship FDA Certified N95 Masks

NEXVOO®, a global innovation leader in unified communications products, announces that it is assisting with the US and global pandemic by shifting resources to help with shipping FDA Certified N95 mask supplies into the US.

ALIVECOR: New FDA Guidance Allows Use of KardiaMobile 6L to Measure QTc in COVID-19 Patients

World's only FDA-cleared six-lead personal ECG will be used by healthcare professionals to monitor QT duration in patients receiving medications that can cause potentially life threatening QT prolongation.

BIOHAVEN: To Advance Vazegepant into Phase 3 for the Acute Treatment of Migraine Following Successful End of Phase 2 Meeting with FDA

In previously reported positive topline results from pivotal Phase 2/3 clinical trial in December 2019, vazegepant achieved statistical superiority to placebo on the co-primary regulatory endpoints of pain freedom and freedom from most bothersome symptom at 2 hours

FDA: Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes

As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process.

FDA: Coronavirus (COVID-19) Update: FDA Helps Facilitate Veterinary Telemedicine During Pandemic

As part of the U.S. Food and Drug Administration’s ongoing commitment to combatting the coronavirus (COVID-19) pandemic and providing flexibility across FDA-regulated industries, the agency announced that it intends to temporarily not enforce certain requirements in order to allow veterinarians to better utilize telemedicine to address animal health needs during the pandemic.

FDA: Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing.

CEPHEID: Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test

Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.

FDA Reporter