Nursing Product Guide » FDA

Medical Acoustics Lung Flute Selected by Popular Science Magazine for 2009 BOWN Award

Jim Marino — Wed, 09 Dec 2009 13:35:09 +0000

Medical Acoustics LLC has announced that its FDA-cleared Lung Flute^®, a diagnostic and therapeutic respiratory medical device, was selected by Popular Science magazine for inclusion in the magazine’s prestigious Best of What’s New (BOWN) awards for 2009. The Lung Flute® is the first respiratory medical device that harnesses the non-invasive power of low frequency sound waves to mobilize deep lung secretions.

American Biotech Labs(R) Wins FDA Clearance for New Prescription Wound Dressing Gel

Jim Marino — Wed, 25 Nov 2009 14:38:23 +0000

American Biotech Labs has announced that it has obtained clearance by the FDA to market its ASAP Antibacterial Silver Wound Dressing Gel as a prescription 510(k) medical device throughout the United States. The FDA 510(k) medical device clearance enables ABL to market its ASAP Antibacterial Silver Gel “for use in the management of 1st and 2nd degree burns, stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears and surgical incision sites.

APP Pharmaceuticals Receives Approval For Chlorothiazide Sodium For Injection

Jim Marino — Wed, 11 Nov 2009 12:45:18 +0000

APP Pharmaceuticals, Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market Chlorothiazide Sodium for Injection, USP. Chlorothiazide Sodium for Injection, USP is therapeutically equivalent to the reference-listed drug Diuril®, which is marketed by Lundbeck Pharmaceuticals. Chlorothiazide is a diuretic used to treat high blood pressure, and fluid retention in people with congestive heart failure, cirrhosis of the liver and kidney disorders.

Nano Mask moving ahead to get FDA approval for NanoMask

Jim Marino — Wed, 21 Oct 2009 15:24:12 +0000

Nano Mask Inc has retained AlvaMed LLC, an FDA consulting firm specializing in medical devices, to prepare the company’s latest generation disposable, anti-viral NanoMask for FDA approval. Doug Heath, CEO of Nano Mask, has indicated that the company is looking forward to working with AlvaMed’s team in obtaining the FDA approval in a timely manner.

FDA gives 510(k) clearance for BD Vacutainer

Jim Marino — Wed, 14 Oct 2009 06:57:04 +0000

BD Diagnostics – Preanalytical Systems, a unit of BD (Becton, Dickinson and Company), has received the FDA 510(k) clearance for the BD Vacutainer® Rapid Serum Tube. BD Vacutainer is a blood collection device designed to help acute healthcare facilities rapidly analyze blood serum for patient diagnosis. Technologies such as the BD Vacutainer Rapid Serum Tube can help reduce the time it takes to get answers from blood tests and have a significant impact on patient care and hospital productivity.”

FDA warns against respiratory medications from Mylan

Jim Marino — Wed, 30 Sep 2009 06:53:30 +0000

The FDA is advising consumers not to use certain respiratory medications made by Canonsburg-based Mylan Inc. The FDA says the medications may have been the part of a shipment being transported on a tractor-trailer that was stolen in Tampa, Florida, on September 8, 2009. The alert involves the Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution. People who use the medications should check to see if they have any products that were received or purchased after September 8 and return them to the pharmacy where they were bought.

Noveko aiming for FDA approval for its surgical mask

Jim Marino — Wed, 22 Jul 2009 05:00:07 +0000

Montreal’s Noveko International Inc, which is commercializing antimicrobial filter technology across the world, has until October 23, 2009 to file extra data on its surgical masks with the US regulators. Noveko’s chief operating officer, Alain Bolduc, believes that the company’s proprietary product will be the first one among the antibacterial surgical mask products to receive the FDA approval.

New FDA rules require stricter warning for pain relievers

Jim Marino — Wed, 08 Jul 2009 11:37:09 +0000

The FDA has implemented rules that require drug companies to place stronger warnings on the labels of common over-the-counter pain relievers about the risk of liver damage and stomach bleeding. The FDA’s Matthew Ray Holman, PhD, says the new warnings are necessary “to raise consumer awareness about the potential for liver damage when using acetaminophen (such as Tylenol) and the potential for stomach bleeding when using a nonsteroidal anti-inflammatory drug,” commonly called an NSAID. NSAIDs include aspirin, ibuprofen, naproxen and ketoprofen.

Intel unveils the Intel Health Guide, a tablet-PC

Jim Marino — Wed, 17 Dec 2008 12:11:33 +0000

Intel Corporation has announced the Intel Health Guide, a tablet-PC which offers management tools for health care professionals that treat patients with chronic conditions. The Health Guide represents Intel’s entry into a new category of personal health systems, and it promises functions beyond the simple, common remote patient monitoring systems, providing a wider range of processing abilities. The Intel Health Guide received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) in July 2008. It’s a comprehensive personal health system that combines an in-home patient device, the Intel Health Guide PHS6000.

Oculus Innovative Sciences announces the launch of Microcyn Wound Care

Jim Marino — Mon, 17 Nov 2008 13:06:08 +0000

Oculus Innovative Sciences, Inc., has launched Microcyn Wound Care product into the U.S. podiatry market. The product has received three FDA 510(k) clearances for use in moistening, lubricating, cleaning and debriding wounds. It is available to podiatrists for treatment of, and distribution to, their patients in 8 oz. and 500 ml. bottles. Oculus is also pursuing a U.S. drug approval using a different formulation of the Microcyn Technology. The company intends to secure a partner that will assume clinical, regulatory, and commercial responsibilities along with costs for the drug formulation approval.