During a speech in early December last year, Bill Maisel, the deputy director for science at the FDA’s Center for Devices and Radiological Health, expressed a positive outlook for the new medical device industry.
The center supervises medical device approval. Maisel said that the center had made great strides with fixing how long it takes to approval trials and yet-to-be-approved medical devices.
The comments regarding this topic were made at FDA Update, which is an event for MassMEDIC members. MassMEDIC is a medical equipment industry advocacy group. FDA Update provided members a snapshot of important issues regarding regulatory approval.
An MIT and Harvard graduate, Maisel addressed various advances the center has made in getting new medical devices to the American public. He said the agency will match or improve upon its own deadlines for approvals. And in the past few years, they have halved its long list of pending medical device approvals.
He said the agency cut the average time frame between an application’s submission and possible approval by 75 percent in three years. It took around 400 days to process applications in 2011, whereas it only too around 101 days in 2014.
He also said the agency tried to analyze whether a new piece of medical equipment should be reclassified from high-risk to less-demanding devices to help expedite the decision-making process.
Additionally, a new “Expedited Access PMA” program will create more communication avenues between high-risk product companies and the agency. Maisel hopes also to better its level of customer service. They will collect feedback and eventually hope to achieve a 70 percent satisfaction rate with government agencies who work with the FDA and industry representatives.
He said the Center for Devices and Radiological Health reached an 84 percent approval rating, which surpassed their goal.
Ultimately, he wants U.S. patients to have first access to the latest and best technology to hit the market – a goal for 2015.
Absolute Medical Equipment provides FDA-approved-refurbished and new medical devices. If you have questions about acquiring a specific piece of medical equipment, please call us today at 888-267-2966. Learn more about our available medical devices on our website.
“What is a defibrillator? A defibrillator, also known as an AED (Automated External Defibrillator), is a medical device that evaluates the heart beat. When necessary, the defibrillator delivers an electrical shock to help re-establish an effective rhythm.”
New York-based Absolute Medical Equipment, which buys and sells new and certified refurbished medical equipment, continues to see an increasing demand for its pre-owned medical equipment amid a stock of nearly 10,000 machines.
One of the main reasons for this is that the current medical system continues to see a decline in hospital reimbursements. For example, an MRI reimbursement used to be around $1,500; however, it’s now around $400. Facilities are unable to afford equipment like an MRI machine that costs thousands of dollars when reimbursements are decreasing. Greater demand for used medical equipment began about five years ago, noted Absolute Medical’s co-owner Ashley Herschman.
Absolute Medical primarily purchases its pre-owned equipment through banks, manufacturers and leasing companies, though the company has purchased equipment directly from private practice offices and hospitals. The 13-year-old company buys almost any piece of medical equipment, as some devices can be utilized for parts.
Pieces are frequently bought in “as-is” condition. The company utilizes three biomedical technicians to service the medical equipment and get it FDA-certified. The sophisticated process involves a number of checks and balances to ensure quality control and to provide the safest medical equipment to help save lives.
Absolute Medical’s clients include hospitals, private practice doctors, technicians and clinics.
Payment in full is received through certified funds or wire transfer, and it is provided in advance or upon receiving.
Absolute Medical buys the following secondhand medical equipment —man of which are cardiac-related machines:
· 3D ultrasound machine
· 4D ultrasound machine
· Electrocardiograms (EKG machines/ECG machines)
· Patient monitors
· Blood pressure monitors
· Stress monitor
· Anesthesia monitors
If you have any questions, or are interested in a quote, please call Absolute Medical at 888-267-2966.
The industrial internet — It’s General Electric’s phrase for how networked software and sensors are combining with physical machinery and medical equipment.
Medical equipment is becoming more sophisticated thanks to technological advances. One of GE’s new connected medical devices includes a CT scanner that can take images of the moment a heart stops beating when it’s linked to a heart monitor.
RTI, a 23-year-old California-based company, is GE’s new software provider and is helping the technology giant’s advancement in the industrial internet field. RTI is using open source DDS (Data Distribution Service) messaging protocol, according to an article on gigaom.com, in order to help machines communicate and send data to each other. RTI’s Connext software is already used by NASA and Canada’s air traffic control system.
A version of its software that connected devices and sensors can use was released in February. The article notes that “in a medical setting a hospital might need to coordinate data between 1,000 beds with 100 separate sensors sending information.”
The article notes that RTI is a member of the Industrial Internet Consortium, which is a group created by GE, IBM, Intel and others, to “build out reference architectures for the industrial internet.” Therefore, DDS may become the platform of choice when helping to connect devices.
To see what GE equipment Absolute Medical has available, visit our website here. Absolute Medical provides medical equipment to hospitals, clinics, doctors’ offices and imaging centers. If you have any questions regarding services or available equipment, like CT scanners, please contact us at 1-888-267-2966.
Absolute Medical Equipment’s Ashley Herschman would like to think that in any militant or terrorist bombing situation that has occurred around the world, perhaps one of the many defibrillators he’s donated helped save the life of an innocent civilian.
Occasionally, he will hear back from a nonprofit with a real-life example of how one of his medical devices helped save a life. That brings Herschman a lot of joy.
“Rather than handing over a signed check, I’m much happier giving away medical devices that directly impact people who find themselves in life-and-death situations,” the new and used medical equipment provider’s co-owner said recently.
For the past 10 years, Absolute Medical’s philanthropic efforts have included loaning or donating tens of thousands of dollars’ worth of defibrillators and other life-saving medical devices (e.g. surgical centers, ultrasounds and anesthesia monitors).
Nonprofits and other volunteer-based organizations in Africa, Ethiopia, Haiti, Israel, India, the British Virgin Islands and Dominican Republic received Herschman’s medical equipment.
EKG stress tests are important diagnostic tests for identifying coronary heart disease. The stress tests have not changed that much but what has changed are a number of key elements to improve the machinery’s ability to record and generate valuable insight into the patients health.Medical practitioners have a lot more freedom to use the machinery that suits them and the patients rather operations being dictated by the constraints of the machines.Other improvements enable doctors and medical practitioners to identify other related diseases and issues related to the hearts performance during the test.The lightweight natures of these wires are a great improvement from the heavy wires before these developments
Bone densitometers are very powerful machine but are generally underutilized and employed in imaging modality. According to research in osteoporotic fractures in woman the numbers of woman with the condition are greater than the population suffering from breast cancer, stroke and heart attack combined. There are three main processes used in bone densitometers and while you may be looking to replace or consider your options here are the different approaches.
Vascular probe research
can help further treatment of vascular disease. The vascular probe can be compared
to many of the other probes. The probe has specific crystals that can then send
ultrasound waves into the patient. Another crystal is designed to receive the
returning wave and they bounce back from the blood cells.
The advancement of the technology has allowed these probes to pick up a range of data when the ultrasound waves hit the cells. They can track blood flow as well as the direction in which the cells are flowing. With use of high low pitch sound they can identify move, flow and its direction, helping identify further details of any problems
obstructive pulmonary disease (COPD) is a form of lung disease and is based on
reduced air flow into the lungs because of the deterioration of the lung tissue
and the dysfunction of the minor airways. Unless treated the disease continually
gets worse. The effects of this disease are shortness of breath and coughing.
The pulse oximeter is non invasive and can easily check oxygen saturation and other vital signs of an individual. Improvements have made the pulse oximeter more attractive and accepted for use in a number of primary and specialty care practice applications.
Medical ultrasound devices have been around for a longtime and
have been heavily associated with gynecology clinics but as ultrasound machinery
becomes increasingly more powerful you will find that a range of other medical
The increase in the use of Ultrasound devices is four main reasons. One is the absence of needles, injections and surgical incisions that are found in many of the previous procedures. The Ultrasound process is painless and also extremely quick to identify any issues in the area being tested. In many instances patients would need to go through an x-ray process to identify problems and collect data. The offset would long term exposure to radiation to the patients which has its side effects and risks. Ultrasound does not have any radiation making it safer and easier for the patients. Patients are happier and it’s easier to position the ultrasound in difficult to reach places and get the readings and results. This is in place of painful time consuming procedures that would require preparation time and recovery time.
Autoclave and Sterilizing machines have
been used for a long time in a number of industries. The process is well known
to prepare and mange utensils and materials used in a clean, sterile
environment. The steam that is applied can cause a strong build up of pressure and
It’s an simple way to keep anything clean.
In actuality all an autoclave is, is a very powerful dishwasher and that in mind has found some interesting applications not just in piercings but in more remote areas like NASA and rocket launches.
are two main concerns that patients have when using a MRI, the environment of
the MRI and the radiation.The
cold and the claustrophobic nature of the procedure and equipment make the patients
usually uncomfortable and practitioners need to keep patients as calm and happy
The claustrophobia is a big part for patients to stay calm to undergo the treatment. They really don’t enjoy it and being restrained for large amounts of time can be really difficult.Patients are always concerned about the side effects or long term effects of radiation.
The possibility to reduce the levels of radiation is always a concern because it is a payoff to image quality and the priority is always to protect that quality.
Vaginal probes are used in sonographic scans. These probes including endocavitary probes really need a cover. The reason for this is that they become semi-critical due to their contact with mucous membranes creating a hazard when sharing the probes with patients. A solution is for probes to have a cover before the probe is applied to each patient. These covers are not fail proof and have been found to tear reducing their protective quality. This has led many to improve their protection to disinfection post examination as well as placing a cover on the probe before any following assessment with a new patient.
fetal monitor is part of the overall observation of the baby. It tracks the
heart rate of the baby and tells us a great deal about the health of the baby
as well as if the baby is under any stress.
Occasional changes in the baby’s heart rate can be caused by the umbilical cord pressing on the baby causing it stress as is worse than episodic acceleration. If the heart rate speeds up then the situation can progress to further categories.
ECG and EKG have achieved a process to identifying and quantifying vital signs
of the heart. Buy putting on electrodes over the heart the electrical impulses
can be recorded and analyzed. There is a continuous need in the cardiology
community to evaluate and improve the analytical abilities of the machinery to
better identify abnormalities.
This constant drive for more accurate and better identification of heart issues using ECG/EKG technology has met, head on, with smart phone technology