Category: FDA

Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.

RapidAI Secures FDA Clearance for...

May 6, 2024

“We are pleased to expand our stroke AI imaging portfolio, the broadest in the industry, to include this new module. With AngioFlow™ by RapidAI, we can now support stroke AI imaging along the entire patient pathway, from the initial non-contrast CT scan all the way to the interventional suite,” said Karim Karti, CEO of RapidAI. “Already registered and used in Japan and Europe, we believe this technology will make a significant difference in the lives of U.S. stroke patients.”

Intuity Medical’s POGO Automatic ®,...

May 2, 2024

Recognized by healthcare professionals for its user-friendly design which can improve testing compliance, POGO Automatic is endorsed as the ideal solution for many diabetes patients by Rosemarie Lajara, MD, an endocrinologist with Southern Endocrinology & Diabetes Associates, P.A. in Plano, Texas

RapidAI Secures FDA Clearance for Perfusion Imaging in the Angiography Suite

May 6, 2024

Ortho-R Receives FDA Regulatory Designation and Jurisdictional Assignment

Ortho-R is designated as a Drug/Biologic combination product, by the FDA Office for Combination Products. The jurisdictional assignment for Ortho-R will be the Center for Biologics Evaluation and Research (CBER). The news was announced today by Ortho Regenerative Technologies. On March 26th, 2020, a pre-Request for Designation application was submitted to the FDA's Office for Combination Products to seek for guidance on designation status for Ortho-R product, a Chitosan-based matrix biopolymer* mixed with Platelet Rich Plasma (PRP) to form an...

August 6, 2020

FDA Takes Action to Limit Inorganic Arsenic Levels in Infant Rice Cereal

"The FDA is finalizing guidance today that will help protect public health by reducing infants' exposure to inorganic arsenic, which has been associated with neurodevelopmental effects.

August 5, 2020

FDA EUA Issued for Impella Heart Pumps to Provide Unloading Therapy to COVID-19 Patients

“The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO,” said Christian Bermudez, MD, surgical director, lung transplantation and ECMO, and professor of surgery at the University of Pennsylvania. “The superior clinical outcomes from the combination of Impella and ECMO are likely the result of reducing the stress on the myocardium and work required of the left ventricle, also reducing secondary lung injury due to pulmonary congestion.”

August 4, 2020

Siemens Healthineers Obtains First FDA EUA for Semi-Quantitative Antibody Test

This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 percent.

August 4, 2020

InterStim™ Micro Neurostimulator and InterStim™ SureScan™ MRI Leads Receive FDA Approval

InterStim™ Micro Neurostimulator and InterStim™ SureScan™ MRI Leads make Medtronic the only company to offer patients and physicians a choice in SNM systems to match their preferences, lifestyle and treatment goals.

August 3, 2020

FDA Grants An EUA Amendment Increasing Applied DNA’s COVID-19 Diagnostic Kit Testing Capacity Through Use of Automated RNA Extraction and Expands Supported Platforms

The EUA amendment extends the RT-PCR platform authorization from the Applied Biosystems (ThermoFisher Scientific) QuantStudio™ Dx to include Applied Biosystems’ QuantStudio™ 5 Real-Time PCR system (“QS5”). The amendment also authorizes the use of the Hamilton STARlet robotic automation in conjunction with the Omega Bio-tek Mag-Bind® viral RNA Express kit to speed the process of extracting viral RNA from specimens and drive greater testing throughput.

July 31, 2020

FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products

The FDA first warned about some of the methanol-containing hand sanitizers being sold in retail stores and online in June.

July 27, 2020

Zebra Medical Vision Secures its First FDA Clearance in Oncology, Boosting Early Detection of Breast Cancer in Mammograms

This latest clearance makes Zebra Medical the first AI startup with six FDA clearances across three different modalities under its belt. In initial testing Zebra-Med conducted, a number of cases which were originally missed were alerted by Zebra Medical’s ‘HealthMammo’ algorithm and the patients were recalled and confirmed

July 27, 2020

Vesta™ RF Cannula Receives FDA Clearance

Vesta™ RF Cannula was developed to provide our customers and their patients a high quality and cost-effective RF cannula to treat pain in clinical scenarios where our Nimbus® RF Multitined Expandable Electrode, that provides a large volume lesion for the treatment of pain, is not indicated.

July 27, 2020