Last year, approval of medical devices by the FDA was relatively the lowest since 2013. However, 2023 looks optimistic with AI and machine learning rising. This year's list of approved medical devices by the FDA is a lot similar to last year with medical technologies like Glucose meters, Stimulators, dermal fillers, Lab tests, heart catheters,
Smarteeva’s Smart Audit Trail is a ground-breaking feature in the post-market surveillance industry. About Smarteeva: Based out of Santa Barbara, CA. Smarteeva Software provides cutting-edge and innovative Post Market Surveillance applications for the Medical Device industry. Smarteeva’s Complaint Handling, Adverse Event Reporting, Risk Management and Recall Management solutions prioritize compliance,
Wearing tech in the healthcare industry is the next evolution GE has tapped into. Combining hardware and software abilities GE developed a revolutionary wireless monitoring solution, Portrait Mobile, a part of its FlexAcuity monitoring solutions. GE’s Portrait Mobile wireless and wearable monitoring solution has now received a green light from the FDA. Portrait Mobile’s innovative
The ability to deliver fluids at automated intervals is one of the major advantages of infusion pumps. The increasing demand for safety-driven, patient-focused and clinician-friendly infusion pumps is beneficial for healthcare providers by giving an edge to manufacturers using automation to make high-quality pumps. However, the infusion pump market recently has been troubled by security
So far in 2023, patient problems reported to the FDA as MDRs are related to high-volume procedures and devices. Data says increasing numbers of implant procedures like dental, breast, hips, knees and others contribute to patient problems reflected in the word cloud such as failure of implants, pain, fibrosis, and capsular contracture. Patients reported problems
Smarteeva, a premier post-market surveillance partner to global medical device companies, is excited to announce the release of its Summer 2023 Post Market Surveillance Suite. The new Post Market Surveillance suite elevates the existing Smart Complaint System with artificial intelligence, making user-friendly FDA MDR reporting, complaint handling, and Recall Management. Plarent Ymeri, CEO of Smarteeva
At Smarteeva, we interact with numerous medical device industry insiders and pay attention to where their processes and investments are going. Most medical devices processed are mature. However, newer technologies facilitate possibilities for better process adherence, efficiency, and product safety. Here are the top 5 trends we witnessed: Partner & Customer Self-Services: Consumer-grade medical
The FDA requires Medical Device Reports (MDRs) submission within 30 days of Complaint Awareness and utilizes a variety of code types to classify these MDRs. One of the code types is Patient Code, divided into Health Effect – Clinical Codes & Health Effect – Impact Codes. For the past eight years patient death as
Smarteeva maintains an internal database of medical device adverse events. We use public data such as MAUDE with other internal and external data sources. This data is cleaned and correlated to make it more user-friendly. We looked at the top MDR submitters in 2022 using our data cleanup technology and found that the top submitters
The Increase in the Volume of Complaints and MDR reports In the past 10 years, the number of MDRs reported to the FDA has increased at a steady 20% pace annually. In 2010, the number of submitted complaints was 337,838. In 2022, it had increased to over 3 million. Making it a steady rise of
