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Case Study

By |2023-09-28T13:25:54+00:00September 28th, 2023|News|

Smarteeva solves High Volume Complaints handling challenges for a Medical Device company   About Medical Device Customer One of the largest manufacturers and producers of glucose monitoring systems required an overarching system for Post-Market surveillance and an effective Complaint management system. Even though the business had a top quality complaint management system in the market,

Blog 3/4: Product Recalls by the FDA 2023

By |2023-09-26T13:24:47+00:00September 25th, 2023|News|

According to a recent Sedgwick report, the first quarter of 2023 saw increased U.S. medical device recalls by 4.6% to 252 events, and defective units increased by 34.3% to 83.3 million. For the first time in more than seven years, manufacturing defects were the leading cause of recalls with 59. A cross-sectional study of all

Blog 2/4- Product recalls by the FDA in 2023

By |2023-09-26T13:24:33+00:00September 21st, 2023|News|

2022 was a record-breaking year for the number of units recalled, reaching nearly 1.5 billion. For the second consecutive year, more than 1 billion units of food, drugs, medical devices, automobiles, and consumer products were recalled in the U.S. According to Sedgwick's latest State of the Nation recall index report. With tougher consumer regulations on

Blog 1/4- Product Recalls by the FDA

By |2023-09-26T13:24:07+00:00September 19th, 2023|News|

A product recall is the process of retrieving defective and/or potentially unsafe goods from consumers while providing those consumers with compensation. Recalls often occur as a result of safety concerns over a manufacturing defect in a product that may harm its user. A product recall may be voluntary or mandated by a regulatory body.  Data

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Blog 6/6- FDA approved devices 2023 ft. Stimulators

By |2023-09-01T13:38:45+00:00September 1st, 2023|News|

The increasing prevalence of chronic diseases, the rising geriatric population, and technological advancements in nerve stimulators have led to the growth of the Nerve stimulator market at a CAGR of 7.5% by the year 2028. Nerve stimulators are said to help patients with conditions such as Depression, Sleep Apnea, Epilepsy, Dystonia and more.  Spinal cord

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Blog 5/6 – FDA Approved Devices Ft. Stents & Catheters

By |2023-08-31T14:35:54+00:00August 31st, 2023|News|

In 2023 FDA gave the green light to several minimally invasive medical devices. Last year the global market size of stents accounted for more than USD 8.6 billion and now the trajectory is expected to rise by 4% between 2022- 2028. Catheterization is a type of co-procedure that is projected to reach $49.5 billion (approx)

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Blog 4/6- FDA Approved Devices 2023 ft. Spinal Implants

By |2023-08-30T13:22:19+00:00August 30th, 2023|News|

Spinal Implants are medical devices used by surgeons to treat deformity, stabilize and strengthen the spine and facilitate fusion. The global Spinal Implants market is estimated to reach USD 13.8 billion by 2025. This market is primarily driven by the advancements in spine surgery technologies, increasing incidence of Spinal disorders, the launch of advanced bone

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Blog 3/6- FDA approved Medical Devices Ft. Lab Tests

By |2023-08-29T13:45:36+00:00August 29th, 2023|News|

70% of today’s medical decisions depend on laboratory test results, showing the important role of clinical laboratories in today’s healthcare system. More than 14$ billion tests are ordered annually to maintain effective diagnosis and treatment. However, newer lab tests driven by technology are entering the market with FDA’s approval.  Foundation Medicine, Tempus Labs, Siemens Healthcare,

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Blog 2/6- Approved Medical Devices by the FDA 2023

By |2023-09-06T05:43:15+00:00August 28th, 2023|News|

With the rise in minimally invasive procedures, Injectable and gel implants are becoming the new normal among patients. The global market size of Dermal fillers is expected to increase by 10% in 2031 and is currently valued at more than $2 billion and growing. These medical device implants are approved by the FDA to improve

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Blog 1/6- List of approved Medical devices by the FDA in 2023

By |2023-08-29T14:11:12+00:00August 25th, 2023|News|

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,

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