The Latest Surgical Technology News: Medgadget

Surgery

October 16th, 2018

Surgery

New PICO 7Y Negative Pressure Wound Therapy System to Treat Two Sites at Once

Smith & Nephew is launching its brand new PICO 7Y negative pressure therapy system designed to be able to treat two wounds at the same time. The system uses a single pump that can support two dressings via a special Y extension, helping with...

October 16th, 2018

Surgery

GE Healthcare Unveils New Automated Breast Ultrasound for Dense Breasts

GE Healthcare is unveiling its brand new Invenia Automated Breast Ultrasound (ABUS) 2.0 in the U.S. It is the only FDA approved "ultrasound supplemental breast screening technology," which allows for spotting of cancerous lesions within dense...

October 16th, 2018

Surgery

Microlaparoscopic Robotic Surgeries Now Cleared on TransEnterix Senhance System

TransEnterix, the maker of the Senhance robotic surgical system, won FDA clearance for its new 3 millimeter line of instruments, as well as some more 5 mm instruments. At only 3 mm in diameter, the new instruments make it possible to use...

October 15th, 2018

Surgery

FDA Clears DuraSorb Bioabsorbable Surgical Mesh

Surgical Innovation Associates, headquartered in Chicago, Illinois, won FDA clearance for its DuraSorb Monofilament Mesh. The bioabsorbable surgical mesh is designed for use in reconstructive and cosmetic surgeries, providing structural support...

October 9th, 2018

Surgery

MAGNETOM Sola MRI from Siemens with BioMatrix Technology Cleared by FDA

The FDA has cleared the MAGNETOM Sola 1.5 Tesla MRI machine from Siemens Healthineers, a device that features the company's BioMatrix patient-centric technology, previously only available on 3 Tesla scanners. BioMatrix accounts for...

October 2nd, 2018

Surgery

Thromboresistant Hydrogel Materials for Venous Catheters: Interview with CEO of Access Vascular

Access Vascular, based in Massachusetts, has developed a peripherally inserted central venous catheter (PICC) composed of a thromboresistant hydrogel material. The catheter could reduce the incidence of catheter-related thrombi and resulting adverse...

October 1st, 2018

Surgery

TransEnterix Gets EU Green Light for Senhance Ultrasonic Instruments for Its Robots

TransEnterix, one of the new competitors in the minimally invasive robotic surgery market, received European CE Mark approval for its Senhance Ultrasonic Instrument System. The instruments are used on the TransEnterix Senhance robitically...

September 28th, 2018

Surgery

MENTOR CPX4 Smooth Tissue Expander for Easier Implantation Post Mastectomy

MENTOR, a J&J company, is releasing a new tissue expander for breast reconstruction surgeries that features a smooth surface. The new CPX4 device, used to make space for a breast implant following a mastectomy, was designed to make it...

September 27th, 2018

Surgery

Ethicon Unveils Bariatric Revision Surgical Solution

Ethicon, a part of Johnson & Johnson, is releasing a whole new set of surgical products for performing bariatric revision surgeries, along with complementary education and training, for performing reoperations. Bariatric reoperations are...

September 25th, 2018

Surgery

Mobile Clinics for Disaster Zones and Low Resource Communities: Interview with CEO of World Housing Solution

World Housing Solution, based in Florida, specializes in rapidly deployable buildings. Recently, they have focused on providing fully-equipped mobile clinics that can be fabricated and installed very quickly in disaster zones. The clinics are...

September 24th, 2018

Surgery

"Spray-On Skin" from AVITA Medical Approved to Treat Serious Burns

AVITA Medical, a Valencia, California firm, won FDA approval for its remarkable RECELL Autologous Cell Harvesting Device for serious burns in adult patients. In preparation for treatment, a small healthy piece of the patient's skin sample is taken,...

Upcoming conferences

october

18octallday19alldayWorld Congress on Polycystic Ovarian Syndrome and Fertility, 2018Abu Dhabi, UAE

18octallday19alldayManaging Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an InspectionMinneapolis, MN, USA

Event Details

Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

How to overcome one of the biggest obstacles device manufacturers face
How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

**New course materials have been added, updated content will include:

Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.

Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions.

Time

october 18 (Thursday) - 19 (Friday)

Organizer

Compliance Online 80068SEM

Learn More

Calendar GoogleCal

18octallday19allday18th Global Ophthalmology, Optometry and Glaucoma Conference, 2018Helsinki, Finland

18octallday19alldayBiology and Pathology of Infectious Disease Conference, 2018Helsinki, Finland

18octallday19allday14th Global Biomarkers Summit, 2018Amsterdam, Netherlands

22octallday23alldayInternational Conference on Breast Cancer, 2013Vancouver, British Columbia, Canada