Welcome to the July 10 edition of ‘Pathways Picks’, our MTS Market Pathways’ weekly roundup of the most important global medtech regulatory, reimbursement, and policy news. This week: Elizabeth Warren watches the device space, China pilots UDI, another notified body bows out and more. Download a copy of the first issue of Market Pathways and look for updates here.
Many of the world’s greatest scientific discoveries have been made by women in medtech history. This post celebrates Rosalyn Yalow, PhD, an American medical physicist who was a co-winner of The Nobel Prize in Physiology or Medicine in 1977—the first American woman to be honored with this achievement—for the development of radioimmunoassay (RIA). The method of measuring previously unidentifiable peptide hormones revolutionized biological and medical research, and led to many of today’s key diagnostics technologies.
“Robots Hug the Heart for HF Relief” Houston-based start-up, CorInnova Inc., is developing a minimally invasive soft robotic cardiac device that they anticipate will shift the paradigm of existing heart failure (HF) treatments, and may reverse the progression of HF or even prevent its development in post-heart attack patients. In this interview, CEO William Altman and Senior Biomedical Engineer Christina Bolch talk about their experiences in getting the company and its technology where it is and what’s next for CorInnova.
In 1940, World War II was raging across Europe, color TV was transmitted for the first time, the first US superhighway was opened, and a seismic shift took place in orthopedic surgery that would change the lives of patients with intractable hip arthritis pain or fractures – the first hip replacement surgery with a metal implant was performed.
This week MedTech Strategist is launching a new publication to deliver global regulatory and reimbursement insights to the medical device industry: MedTech Strategist Market Pathways: Global Regulatory, Reimbursement, and Policy Review. The highly-anticipated publication will be the go-to source to help industry make sense of the increasingly complex web of medtech market access policies worldwide.
“VerteCore: Wearable Spinal Decompression” Mississippi medical device start-up, VerteCore Technologies LLC, has developed VerteCore Lift, a wearable orthopedic device, to innovate the way back pain is managed. The device alleviates nerve root impingement related sciatica and neurogenic intermittent claudication that results from spinal stenosis with mobile, non-surgical decompression. In this interview, co-founder and CEO, Paul Leake talks about his experiences in co-founding the company and what’s next for VerteCore.
This week we celebrate the one-year anniversary of MedTech Strategist’s Community Blog, and the In MedTech History series, with a powerful quote that suits today’s thriving, evolving, innovative, life-saving medical device industry perfectly:
"If I have seen further it is by standing on the shoulders of Giants." – Sir Isaac Newton, 1675
“LabReady, Set, Go: Accurately Diagnosing Infections Faster and From Home” Houston medical device diagnostics start-up, Vax-Immune Diagnostics LLC, has developed LabReady, a hand-held, portable, disposable device. This novel diagnostic platform device was designed to revolutionize the identification process of infectious disease. In this interview, co-founder, President, and CTO Leonard Weisman, MD talks about his experiences in co-founding the company and what’s next for Vax-Immune.
The year 2003 was historic for a number of reasons: the Iraq War, the loss of the Space Shuttle Columbia and her crew, and the conclusion of the world's largest collaborative biological project: the Human Genome Project. The knowledge gained from this successful 13-year scientific endeavor has since ushered in an emerging era in genomics and precision medicine, making it possible to predict, diagnose, and treat diseases more precisely and personally than ever.
Amidst a growing counterculture sparked by the Vietnam War and the US civil rights movement, bariatric surgery as we know it today had its beginnings in 1965 in a research laboratory at the University of Iowa. Today, as obesity reaches epidemic proportions, bariatric surgery has established its place as the most effective treatment for achieving substantial weight loss and improving or even resolving comorbid conditions such as diabetes, hypertension, and sleep apnea, especially in the morbidly obese.
“A Hole in the Heart Alleviates HF Symptoms” Houston medical device start-up, Alleviant Medical, is developing a novel transcatheter technology that applies left atrial decompression to provide symptomatic relief for congestive heart failure. In this interview, co-founder and CMO Jacob Kriegel, MD talks about his experiences in co-founding the company and what’s next for Alleviant Medical.
Atrial fibrillation (AF), the most common type of cardiac arrhythmia, affects millions of people worldwide. Thanks to pioneering work by Melvin Scheinman, MD and others nearly 40 years ago in catheter ablation, the need for open-heart surgery or long-term drug therapy for hundreds of thousands of patients with AF or other serious heart rhythm disturbances has been nearly eliminated.