PRESS RELEASES
View our latest Press Releases below that include new information from our global medical market research. If you would like to be notified of new research, press releases, articles relating to your products or market you can sign up here.
BioSerenity Announces FDA Clearance for Electroencephalography (EEG) Wearable Device System
BioSerenity, Inc., recently announced they received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Neuronaute® Electroencephalography (EEG) System and IceCap® EEG wearable device that allows physicians to remotely monitor patients with epilepsy. In general, EEG devices record the electrical activity of neurons in the brain through electrodes placed on the scalp (non-invasive) or
How Many Cardiac Surgeries Are Performed Each Year? – New Study by iData Research
According to a new cardiac surgery market study by iData Research, the number of cardiac surgeries exceeds 900,000 procedures each year in the United States. The US Cardiac surgery market is growing rapidly driven by the growth of many underlying procedures. The number of cardiac surgery procedures commonly includes: • Coronary Artery Bypass Grafting (CABG)•
Can AI Help Improve In-Vitro Fertilization Rates?
Although in vitro fertilization solely involves a sperm and an egg, the process leading to an embryo can be more challenging than just putting the two together. In 2019, the Centers for Disease Control and Prevention (CDC) reported that approximately 10% of women in the U.S. between the ages of 15-44 had difficulty either getting
Over 190,000 Atherectomy Procedures Performed Every Year In The United States
According to a new atherectomy market study by iData Research, over 190,000 atherectomy procedures are performed each year in the United States. Atherectomy is a procedure that consists of removing atherosclerotic plaque from diseased arteries and can be performed either on coronary or peripheral arteries. Atherectomy devices are used as the treatment of choice, as
Medtronic’s MIS Drill Received FDA Approval Ahead Of Schedule
Medtronic has announced that the U.S. Food and Drug Administration (FDA) has cleared the use of navigated interbody high-speed drills with the Robotic Guidance System. Even in the midst of the COVID19 pandemic the company has received the clearance earlier than anticipated. This system now integrates the surgical planning software with robotic guidance. Spinal instruments
Top Ventilator Companies In The World
As COVID19 is mainly affecting the respiratory system and develops the common flu-like symptoms, hospitals around the globe are facing shortages of many respiratory care devices, including ventilators. Since the breakout, the demand for ventilators has grown substantially and resulted in governmental and industrial support driving the pace of ventilator manufacturing. Due to the major
Understanding the COVID-19 Impact on Sales of Medical Devices at the SKU Level
Product managers are continuously looking for data and insights to support strategy and to find valuable market information. Companies in industries that are private and guarded find themselves in situations where their questions are usually longer and more complex than possible answers. In 2020 the emerging question is: “what is the impact of COVID-19 in
Carestream Validates 3D Printer created by Formlabs
Formlabs has recently announced the integration of Draft Resin with orthodontic model 3D printing . This material has been named a “groundbreaking material” for rapid orthodontic aligner and retainer production due to the speed at which it can print. Draft Resin not only incorporates being the stiffest material in Formlabs repertoire but also allows users
Can Major Gynecologic Cancer Surgeries Continue Safely in the COVID-19 Era?
Gynecologic cancer or reproductive cancer refers to any part of the female reproductive system: cervical, ovarian, uterine, vaginal, and vulvar. The risk of gynecologic cancers increases with age. Like any other type of cancer, gynecology cancer is difficult to detect only by external symptoms; in some cases, early cancer may be detected during clinical exams
Top TAVR Companies in Europe
Based on the latest market analysis by iData Research, the European Transcatheter Aortic Valve Replacement (also known as TAVR/TAVI) market was valued at €836.2 million in 2020, which is a 29% decline from 2019 due to COVID19. TAVR is a minimally invasive procedure to replace the diseased aortic valve in patients with severe aortic stenosis.
Innovative Dental Scanning System by 3Shape
3Shape has released a new and improved version of their old TRIOS 3 with the TRIOS 4. The TRIOS system is a complete in-house product that includes a scanner and extensive design software to create a digital impression of the tooth’s anatomy. Digital impressions offer patients the convenience of not having to endure traditional impressions
Top Dental Cements Companies in the United States
We have already looked at the top companies in the Dental Materials Market overall but now we go deeper to look into the dental cements market in particular. Dental Cements are sealing agents that are predominantly used to fill any gaps between restorations and the natural tooth. For the past 5 years, the US Dental
Medtronic’s Newest Form of Communication with the Heart
Medtronic has released its first-ever app-connected pacemaker called Azure. A pacemaker is an implantable device designed to regulate the electrical impulses of the heart. They are used to correct uneven heartbeats. Millions of patients have pacemaker implants to treat arrhythmia or heart failure. However, many patients do not understand how these devices function. This smartphone-connected
Over 182,000 Heart Valve Replacements Per Year in the United States
According to the latest Cardiac Surgery market study by iData Research, over 182,000 heart valve replacements are performed every year in the United States. Heart valve replacements are one of the most common procedures performed in cardiac surgery market, and they make up nearly a quarter of the total procedure volume. Heart valve replacement procedures
Stryker Goes to Extrem(iti)es with Wright Medical Acquisition
Stryker has announced it has cleared all regulatory hurdles previously in the way of its planned $4.7 billion acquisition of Wright Medical. The tender offer was initiated back in November 2019 and has now been completed as of November 11, 2020. “Wright Medical has built a successful business, and together we look forward to working
Top 3 Syringe and Needle Companies in the United States
As we progress through the global pandemic and drive closer to having a vaccine available, companies are now preparing supplies such as needles and syringes. We have compiled the top three companies to watch as distributors for needles and syringes in the United States. Becton Dickinson Cardinal Health Novo Nordisk Becton Dickinson Becton Dickinson produces
FDA Approval of TAVR in Low-Risk Patients Set to Drive Market Growth
Register to receive a free TAVR Market Report Suite for the US 2020-2026 synopsis Based on the latest market analysis by iData Research, the Transcatheter Aortic Valve Replacement (TAVR) market was valued at $2,424 million in 2020, which is a 13% decline from 2019 due to COVID19. TAVR is a minimally invasive procedure to replace
Best-Selling Large Volume Infusion Pumps in the United States
Based on the latest market study by iData Research, the US infusion pump market was valued at almost $1,176 million in 2019. However, due to COVID, the market size is expected to shrink by an astonishing 51% and reach a valuation of $572 million in 2020, before rebounding in 2021. The infusion pump market is
Anika Announces New Wrist Replacement Technology – WristMotion System
Anika Therapeutics, Inc. announced that the WristMotion Total Arthroplasty System received 510(k) clearance from the U.S. Food and Drug Administration. The WristMotion System is used in procedures to replace painful wrist joints due to rheumatoid arthritis, osteoarthritis, or post-traumatic arthritis, allowing a patient to maintain native biomechanics. This replacement implant is an entirely new approach
Pump Infusions Projected to Be Taking Over the European Market by 2026
According to the latest market study by iData research, the European Infusion Therapy market size was estimated at around $926 million in 2020 which is almost a 10% decline from the previous year. COVID-19 is expected to play a significant role in this market due to elective procedure deferrals as well as restrictions limiting sales
Over 13 Million Laparoscopic Procedures are Performed Globally Every Year
Based on the recent market study performed by iData Research, over 13 million laparoscopic procedures are performed globally every year. Laparoscopy is a minimally invasive surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis through small incisions, (5mm-15mm) eliminating the need for large incisions in the skin. Laparoscopy, also
LATEST!! Covid-19 Causes Major Impacts on Neurologic Disorders
The novel coronavirus (COVID-19; SARS-CoV-2) pandemic has affected millions worldwide. There are still many unknowns surrounding this virus yet one thing is for sure, in serious cases the virus causes devastating effect on the body – and not just on the lungs. “Neurology Online Journal“ has published a new study showing that the COVID-19 virus
World Spine Day 2020 – BACK ON TRACK
October 16th is the official World Spine Day, organized and coordinated by the World Federation of Chiropractors. This year’s theme is Back On Track, celebrating people being able to reactivate and revitalize their bodies by getting out and focusing on effective spine care. World Spine Day is celebrated to raise awareness around the prevention and
Dental Amalgam Market Outlook For 2021
According to the latest market study by iData Research, the US dental amalgam market size was valued at over $89 million by 2020. Amalgam was the first filling material ever used in dentistry and is essentially an alloy of different metals, primarily mercury (~50%) and silver (~22-32%). Amalgam material was the predominant restorative material up
Top Dental Materials Companies in the US
Overview The American population is becoming more aware of the benefits of oral health as more information is provided. With more positives attributed to oral care, the overall dental market has seen an upward trend in more dental office visits for diagnostic and preventative procedures. However, this allowed identifying major threats to oral health and
Over 965,000 Angioplasties (PCIs) are Performed Each Year in the United States
According to the latest interventional cardiology procedural analysis by iData Research, over 965,000 angioplasties are performed each year in the United States. An angioplasty, also known as percutaneous coronary intervention (PCI), is a procedure that involves stent placement to open blocked or narrowing arteries. Interventional cardiology is primarily applied to the treatment of coronary artery
Axeos™ – Dentsply Sirona’s Newest Imaging Solution
iData Research analysts have found that the continually expanding line of Orthophos devices has given Dentsply a broad range of devices to suit all a clinic’s needs, the Axeos is another addition to their already large suite of devices. The large range of FoV’s allows for many different treatment areas, including specialized 3D imaging. The
Teleflex Announces Expanded Indications For Intraosseous Vascular Access System
Teleflex has announced its receival of 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indications for the use of the Arrow® EZ-IO® Intraosseous Vascular Access System. This device is used to provide procedural guidance within the establishment of intraosseous vascular access, especially when intravenous access is difficult to obtain in
Radical Market Share Shifts due to Smith+Nephew’s Acquisition of Integra LifeSciences’ Extremity Orthopedics Division
Smith+Nephew (LSE:SN, NYSE:SNN) have announced that they have an agreement to acquire the Extremity Orthopedics business of Integra LifeSciences Holdings Corporation (NASDAQ:IART) for $240 million. Smith+Nephew noted that the portfolio includes devices, implants and instruments designed for shoulder replacement and reconstruction of bones in the hand, wrist and elbow, as well as the foot and
FDA Allows At-Home Capsule Endoscopy Administration
Amidst the global COVID-19 pandemic, The FDA has granted enforcement discretion allowing CapsoVision the ability to launch at-home administration of CapsoCam Plus®. This device consists of a video capsule system intended for further visualization of the small bowel mucosa in adults. Gastrointestinal (GI) endoscopes are flexible visualization instruments that are inserted into the alimentary canal
COVID-19 Causes Significant Drop in Interventional Cardiology Procedure Numbers
Interventional cardiology is a minimally-invasive technique that uses catheters to treat coronary arterial disease, which is one of the leading causes of death in the United States. These procedures allow the heart to continue functioning at its best moving almost 3,000 gallons of blood every day. Based on the European Heart Journal, cardiovascular disease (CVD)
Top 5 Insights From the Dental Materials Market in Europe
According to the latest study by iData, the European Dental Materials market size is estimated to be at around €700 million in 2020. While the COVID19 pandemic had a major negative impact on the entire dental industry, the European market is expected to return to its pre-COVID numbers within the next two years and reach a
FDA Grants Medtronic Breakthrough Device Designation for Transcatheter Valve System
The FDA Breakthrough Devices Program enables manufacturers to streamline the market clearance/approval process for specific medical devices. Medtronic received the breakthrough device designation for its investigational Intrepid™ transcatheter tricuspid valve replacement (TTVR) system. The FDA has also approved an early feasibility study for the device. The new TTVR system will help treat tricuspid valve regurgitation,
New Cost-effective Microcapsule Used for Endoscopies
Gastrointestinal testing and surveying methods, such as endoscopies and colonoscopies, are often very invasive and are limited in how much of the small intestine they can reach. Thus, there is a need to develop devices or techniques that can both increase the visibility of the gastrointestinal tract and decrease invasiveness while preserving functionality. Pill-shaped forms
B. Braun Gains FDA Clearance for SpaceStation MRI
B. Braun has received FDA 510(k) clearance for its MRI system SpaceStation MRI. Based out of Germany, B. Braun is a leader of infusion therapy and medical imaging devices, as well as a variety of other medical devices. This new imaging technology differs from other MRI systems as it can be used with the Space
Fitbit Used for Early Detection of COVID-19 Symptoms
Currently, the demand for healthcare workers and facilities is extraordinarily high in areas heavily affected by COVID-19. The demand for patient monitoring devices is also high. One of the biggest challenges in reducing the spread of the virus is contact tracing, which is made difficult through a high demand for health personnel, and because of
New Diabetes Test Using Smartphone and Deep Learning
Researchers at UCSF have developed a method to help detect diabetes using a smartphone. They have developed a deep-learning technology that can be combined with a mobile app to offer a low-cost method of detecting diabetes. Instant Heart Rate Measurement The Azumio Instant Heart Rate app was recently used as part of the Health eHeart
Top Product Releases to Follow in the Video Endoscopy Market
According to the latest study by iData Research, the US Video Endoscopy Equipment market was valued at $972 million by 2020. The US market has been growing consistently over the past few years due to the growing popularity of minimally invasive surgery (MIS). Additionally, the market was primarily driven by the replacement of older and
Fujifilm Partners with Caresyntax to Provide New Operating Room and Interventional Integration Platform
Fujifilm Medical Systems has announced they will partner with Caresyntax to develop Fujifilm Systems Integration. Caresyntax, a major developer in automation in surgical equipment and procedures, will be supplying their innovative automation intelligence to help create this Systems Integration. The COVID-19 pandemic has led to an increased need for streamlined surgical procedures and other hospital
COVID-19’s Effect on the Immune System During Pregnancy
Much like during the initial outbreaks of other coronaviruses, there is little certainty regarding the exact effects of COVID-19, especially long-term. However, data about its effects on pregnant women is starting to accumulate and provide preliminary information and precautions. Both the acute and immediate effects of COVID-19 on the mother and child must be considered,
Astonishing 26.9% Decline of Pelvic Floor Repair Market due to FDA Recalls
According to the recent market study by iData Research, the total Pelvic Floor Repair market in the U.S. will consequently decline at a -26.9% cumulative growth rate between the years of 2019-2026. The sharp decline is a result of FDA recalls for all transvaginal mesh devices along with a poor reputation of the sacrocolpopexy surgery. Pelvic organ prolapse
Engage Surgical Granted FDA Approval for Cementless Engage Partial Knee System
Engage Surgical has gained FDA approval for its Engage Partial Knee system, making it the only cementless partial knee system approved for use in the U.S. It uses Engage’s innovative Anchor technology to provide stability at the tibial surface, and increased compression compared to other techniques. The Engage Partial Knee system is also combined with
Osso VR Partnering with MicroPort Orthopedics to Provide VR Training Module for Hip and Knee System
Osso VR has been providing a virtual surgical training platform to provide an education to medical students who are currently unable to receive in-person training due to COVID-19. They have recently partnered with MicroPort Orthopedics, to provide students with an opportunity to take part in VR training of the surgical techniques used by MicroPort. The
Top 6 Surprising Developments in the U.S. Sports Medicine Device Market
According to the latest study by iData Research, the U.S. sports medicine market was valued at $1.7 billion by 2020. The total market is highly limited by the relatively stable incidence rate of tendon and ligament injuries, which varies greatly among different anatomies and different population groups. In spite of this trend, the level of
Anika Releasing Six New FDA-Approved Sports Medicine Products in 2020
Anika, an orthopedic device manufacturer based out of Bedford, Massachusetts, has announced the release of six new sports medicine products in 2020. This marks the first time Anika has released new products since acquiring Parcus Medical and Arthrosurface earlier in the year. All six of these products have received FDA approval. They are mainly focused
Philips Launches Two Portable Biomedical Products In US
Philips has announced the launch of two portable biomedical products, after obtaining FDA approval for them: the Tempus ALS and Tempus Pro. Both of the devices are designed for use with Philips’ Intellispace Corsium software. This web-based platform is used to record and upload data real-time, and it can be used for communication. This adds