I often receive questions to clarify the difference among kits, packaging configurations, and unit of use, and these questions usually inquire about labels or entering data into GUDID. This article answers these questions in simple terms, without citing the regulations, and provides the “mental models” you need to distinguish among the cases and develop a compliant approach.
The definition of what constitutes “innovation” in the medical device industry has become enigmatic in recent years. To drive commercial success in a crowded market, products need to address conflicting sets of user needs while simultaneously addressing market opportunities.
The European market for diabetes monitoring, treatment, and drug delivery currently is undergoing significant changes. The major segments affected by these changes are insulin pumps, continuous glucose monitoring, blood glucose test strips, and insulin pen needles.
Despite global medtech giants’ domination of India’s medical device industry and unfavorable domestic regulations, local startups hope to make lifesaving medical technology more accessible in a country where high-quality, affordable healthcare is scarce. Their products and ideas stand ready to impact markets across Africa, low-income countries in South America, Asia, and even Eastern Europe.
As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”
The industry must be able to demonstrate that it has been able to use the tax suspension to innovate and grow in order to avoid the tax’s reinstatement. The ability to show results will be paramount, creating a need for more efficient online reporting.
Radio frequency (RF) ablation uses RF energy to ablate or destroy unwanted tissues. When delivered via a catheter, it offers a minimally invasive treatment for a wide variety of conditions, including atrial fibrillation (AF). These systems typically include a peristaltic pump to provide cooling or temperature control, and this pump must be able to produce and control the high pressures (up to 130 psi) required in this application.
Shifts in healthcare have essentially changed suppliers’ role in the industry – especially when it comes to infection prevention. And, they’ve greatly impacted how both providers and suppliers think about the use of antimicrobials.
Labels often are an afterthought, because they don’t directly affect the capabilities of a medical device. However, they certainly affect the functionality of the device and users’ ability to effectively utilize all of its features. Consider these factors — and their importance — as you design your medical device overlay or inventory stickers.
GE Healthcare, in partnership with Swedish medical device firm Getinge Group, has launched a “highly flexible” angiography solution for hybrid operating room (OR) procedures. The solution combines GE’s Discovery IGS 730 angiography system with Getinge Group Maquet brand’s Magnus operating table system, which broadens the capabilities and services available in a hospital’s Hybrid OR.
The United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has issued updated guidance to explain whether or not a health app is considered a medical device and is required to comply with regulatory requirements, including getting CE-marked.
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced that it has received CE Mark approval and is launching limited commercial sale of its Surfacer® Inside-Out® Access Catheter System.
A spike in the price of EpiPen auto-injectors has drawn heated responses from patients, lawmakers, and the wider public, who are calling on authorities to rein in soaring prices for the lifesaving devices.
The FDA and several industry advocacy groups have reached a tentative agreement regarding the fourth re-authorization of the Medical Device User Fee Agreement (MDUFA), which is slated for delivery to congress in January of 2017. Under the re-authorization, the FDA will collect close to $1 billion in user fees, money that will be allocated to fund several improvements to the FDA’s review process.
Fortimedix Surgical today announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for FMX314, an innovative single-port platform for use in minimally invasive abdominal laparoscopic surgery.
In the largest and longest clinical evaluation of leadless pacing patients to date, Medtronic plc recently announced new long-term results from the Medtronic Micra Transcatheter Pacing System (TPS) Global Clinical Trial in a clinical trial update late-breaking session at the 2016 European Society of Cardiology (ESC) Congress in Rome.
In the lead up to the European Society of Cardiology Congress in Rome Italy, GE Healthcare recently announced the global commercial launch of its new generation of high-end portable compact cardiovascular ultrasound, the Vivid iq.