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Safety tips for intense pulsed light therapy

March 1, 2012 4:31 am | by U.S. Food & Drug Administration | News | Comments

Article originally published in Nursing2012, February issue. DEVICE SAFETY INTENSE PULSED LIGHT (IPL) therapy is indicated for use in surgical, aesthetic, and cosmetic applications. IPLs use flashlamps, computercontrolled power supplies, and bandpass...

Statin Drugs - Drug Safety Communication: Class Labeling Change

February 28, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

New adverse event and liver enzyme monitoring information in statin labels and updated drug interactions information in lovastatin label.

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Radiological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (April 11-12, 2012)

February 28, 2012 3:31 am | by U.S. Food & Drug Administration | News | Comments

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Norgestimate and Ethinyl Estradiol Tablets: Recall - Packaging Error, Potential for Incorrect Dosing Regimen

February 27, 2012 3:30 am | by U.S. Food & Drug Administration | News | Comments

Women may be left without adequate contraception, and at risk for unintended pregnancy.

Trovagene Expands Business Development Efforts Through a Partnership with Leomics Associates, Inc.

February 27, 2012 1:45 am | by The Associated Press | News | Comments

Trovagene, Inc. (Pink Sheets: TROV.PK), a developer of trans-renal molecular diagnostics, today announced that it has hired Leomics Associates, Inc. to expand its business development activities and monetize the company's high value intellectual property estate. "Trovagene owns a significant...

Industry to CMS: Accuracy, Clarity of Sunshine Act Provisions Needed

February 24, 2012 1:30 pm | by U.S. Food & Drug Administration | News | Comments

Proposed Sunshine Act provisions for documenting devicemaker payments to physicians need more context and clarity, industry members say.

J & #38;J Taps Devices Unit Head to Replace Beleaguered CEO

February 24, 2012 1:30 pm | by U.S. Food & Drug Administration | News | Comments

Johnson & Johnson’s (J&J) upcoming CEO switch, from Bill Weldon to devices business head Alex Gorsky, could signal the company’s confidence in its ongoing relaunch of McNeil Consumer Products, an analyst says.

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Nemschoff Chairs Perinatal Pediatric Hospital Bed (Bassinet): Class 1 Recall - Risk of Injury to Patients

February 24, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

Doors and drawers may inadvertently open while bassinet is in motion; product may be difficult to maneuver due to it swivel caster configuration.

Escalon Announces That the Restructuring of Its IVD Business is Largely Completed

February 23, 2012 11:45 am | by The Associated Press | News | Comments

Escalon Medical Corp.'s (Nasdaq Market: ESMC) subsidiary, Drew Scientific, Inc. ("Drew"), today announced that it has successfully completed the outsourced manufacturing of its HbA1c instruments and recently received the first lot of instruments for sale. Drew has also identified an outsourcing...

CareFusion Cortical Stimulator Control Unit: Class 1 Recall - Software Malfunction and Short Circuit

February 23, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

Affects device and software that aids in the identification and mapping of areas of the brain.

Rubicon Genomics and Agendia Sign Agreement for Use of TransPLEX@ Whole Genome RNA Amplification Technology With SymphonyT Cancer Diagnostics

February 23, 2012 2:45 am | by The Associated Press | News | Comments

Rubicon Genomics, Inc., a company developing and commercializing sample-specific pre-analytical processes to improve the capabilities and performance of DNA and RNA analytical platforms, today announced a clinical supply agreement with molecular diagnostics firm Agendia for its TransPLEX@...

Proto Labs' Latest Cool Idea! Could Improve Quality of Life for 37 Million People Without Sight

February 22, 2012 5:02 am | News | Comments

MAPLE PLAIN, Minn. – The latest deserving idea to receive the Proto Labs Cool Idea! Award, is a Braille labeler by Silicon Valley-based innovation laboratory 6dot. The labeler aims to solve a persistent challenge among the 37 million people around the world without sight: identifying everyday objects.

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Halt Medical, Inc. Closes on First $20 Million of a $50 Million Financing

February 22, 2012 4:52 am | News | Comments

Livermore, CA. Halt Medical, Inc. announced today that it has closed on the first $20 million of a planned $50 million debt and equity financing. “Leading the financing with the first $20 million is our long term investment partner American Capital Strategies (ACAS). American Capital's financial resources...

Thermo Fisher Scientific Extends PCT Assay Licensing Agreement with Wako Pure Chemical Industries, Ltd.

February 22, 2012 4:49 am | News | Comments

WALTHAM, Mass. – Thermo Fisher Scientific Inc., the world leader in serving science, today announced that it has extended its licensing agreement with Wako Pure Chemical Industries, Ltd. to ensure continued use of the Thermo Scientific B·R·A·H·M·S PCT assay on Wako laboratory systems...

Infants' TYLENOL Oral Suspension, 1 oz. Grape: Recall - Dosing System Complaints(2)

February 17, 2012 11:32 am | by U.S. Food & Drug Administration | News | Comments

Reports of dosing syringe flow restrictor being pushed into the bottle when inserting the syringe.

CDRH Transparency: 515 Program Initiative Status Update

February 17, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

Updates to sorbent hemoperfusion system, cardiovascular permanent pacemaker electrode, CES, external pacemaker pulse generator, implantable pacemaker pulse generator, pacemaker programmers

Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication - Choking Hazard and Serious Injuries

February 16, 2012 10:31 am | by U.S. Food & Drug Administration | News | Comments

Brush head may break off in the user's mouth or near the face, causing cuts to the mouth and gums, chipped or broken teeth, swallowing and choking on the broken pieces, and injuries to the face and eyes.

Public Workshop - Design and Methodology for Postmarket Surveillance Studies under Section 522 of the Federal Food, Drug and Cosmetic Act, March 7, 2012

February 16, 2012 5:32 am | by U.S. Food & Drug Administration | News | Comments

This workshop is open to all interested parties, including professionals in the scientific community interested in advancing the infrastructure and methodology for postmarket surveillance studies. The purpose of the workshop is to provide a forum for...

FDA Safety Communication: Choking Hazard and Serious Injuries with the Spinbrush line of Powered Toothbrushes

February 16, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

The FDA is aware of reports of serious injuries and potential hazards associated with the use of the Spinbrush. These reports indicated that while turned on, the brush head has either ?popped off? or broken off in the user?s mouth or near the face...

Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices

February 14, 2012 5:32 pm | by U.S. Food & Drug Administration | News | Comments

The counterfeit version of Avastin does not contain the medicine's active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy.

Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy: Class I Recall - Humidifier Lids Fail to Pop Off at the Intended Pressure

February 14, 2012 4:31 am | by U.S. Food & Drug Administration | News | Comments

The humidifier can leak and can potentially interrupt the flow of supplemental oxygen to the patient.

SQI Diagnostics Announces Agreement with Integrated Sciences in Australia

February 14, 2012 3:46 am | by The Associated Press | News | Comments

SQI Diagnostics Announces Agreement with Integrated Sciences in Australia TORONTO--(BUSINESS WIRE)--Feb 14, 2012-- SQI Diagnostics Inc. (TSX-V: SQD), a medical systems automation company focused on evolving laboratory-based autoimmune biomarker testing, today announced it entered into an...

RegenArouse: Recall - Undeclared Drug Ingredient

February 13, 2012 3:30 am | by U.S. Food & Drug Administration | News | Comments

Product marketed as dietary supplement contains drug ingredient Tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (March 23, 2012)

February 12, 2012 11:31 pm | by U.S. Food & Drug Administration | News | Comments

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

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