End-stage renal disease treatment is a little known but dominant cost driver for the global healthcare system, and the number of patients needing regular dialysis in order to stay alive—and repeated interventions to combat complications—is growing. With its origins as a blood-filtering machine devised from tin cans, sausage casings and other non-medical parts by a determined Dutch physician in World War II Netherlands, today medical device companies such as Healionics are working to address the most critical and costly unmet need in dialysis: maintaining healthy and functional access to the bloodstream.
There are about 466 million people worldwide with disabling hearing loss, 48 million of them in the US. To date, hearing aid devices have been the only solution to sensorineural hearing loss, the kind that comes from aging and the damage loud sounds cause. Eyeing the potential blockbuster opportunity, pharmaceutical companies like Decibel Therapeutics have finally joined the fray.
Robotics were the hot topic at NASS 2018, but discussions also raged about advanced implant materials that have the potential to promote better bone growth and faster healing and reduce reliance on expensive biologics to achieve those goals. An excerpt from Senior Writer Wendy Diller’s November 16 feature, “At NASS 2018, Advanced Biomaterials and the Pull of Robots.”
PAH, a progressive, incurable disease leading to right heart failure that strikes mostly women in the prime of life, has limited treatment options beyond some of the most expensive drugs covered by Medicare. TCT 2018 Shark Tank winner Aria CV hopes to impact the poor prognosis for this disease by focusing its first-of-a-kind, fully implantable device on a fundamental new mechanism of action—mimicking the function of a healthy pulmonary artery.
Apple recently made a splash with its new ECG-enabled watch, but technology from an Israeli start-up may have a better chance of penetrating the multibillion-dollar ambulatory cardiac arrhythmia monitoring market. An excerpt from Executive Editor Mary Thompson’s October 31 feature, “Ambulatory ECG Monitoring Enters a New, More Patient-Friendly Era.”
“FineHeart: A Disruptively Simple Solution for Advanced Heart Failure” France-based FineHeart SA aims to make an impact on the second leading cause of death in the US and in Europe: heart failure (HF) with its first patented product ICOMS. The ICOMS is a hybrid system composed of a pulsatile smart pump, an electrical synchronization module, a control board, and an energy module powered by a TET system. In this interview, CEO Arnaud Mascarell talks about his early inspiration, his experiences in co-founding the company and what’s next for FineHeart.
Behemoth online retailer Amazon is setting its powerful sights on the medical device supply chain. Will the Internet giant have the resolve to invest in the competencies and infrastructure necessary to meet the regulatory demands of healthcare logistics? It faces a number of tailwinds and headwinds in its run at disrupting the healthcare market, says Larry Smith, retired Vice President, Global Supply Chain at BD.
Innovation in the device space isn’t just about next-generation technologies—it also defines the forward-thinking role of today’s medical device supply chain. Here, we look at three key issues impacting supply chain organizations that companies of all sizes need to pay attention to as they grow, expand into developing markets, and as the industry consolidates, according to industry veteran Larry Smith, retired VP, Global Supply Chain at BD. One potential game-changer on the horizon: Amazon.
Last November, FDA issued a long-awaited, final guidance on its standards for overseeing human cell and tissue products. It is the latest move in an ongoing effort by the agency to wrap its arms around the complex, evolving, and controversial area of tissue-based biologics and, by extension, the newer, fast-growing field of regenerative medicine. An excerpt from Senior Writer Wendy Diller’s October 17 feature, “Regulatory Shifts for HCT/P Products Put Orthobiologics Manufacturers on the Spot.”
“Day Zero Diagnostics: Modernizing Infectious Disease Diagnosis” Boston-based start-up Day Zero Diagnostics is developing a sequencing-based rapid diagnostic that identifies both the species and the antibiotic resistance profile of a bacterial pathogen in only hours, not days, which for patients could mean the difference between life or death. In this interview, CEO and Co-founder Jong Lee, MBA talks about his early inspiration and his experiences in co-founding the company, his current priorities, and what’s next for Day Zero.
We continue our conversation about the future of the “eye-catching” ophthalmic device space with Andrew Iwach, MD, Executive Director of the Glaucoma Center of San Francisco, and clinical spokesperson for the American Academy of Ophthalmology. In this installment, we take a look at recent advancements in cataract surgery, that promise to impact the vision of millions of patients worldwide, as well as important unmet clinical needs across ophthalmology.
Sloan Gaon, CEO of PulsePoint, a programmatic health technology company that uses data and technology to engage consumers and personalize healthcare advertising on the web, talks with the Community Blog about how the new Apple Watch and other tech and data initiatives are driving the shift to “radical health personalization.”
At the recent MedTech Conference powered by AdvaMed, held in Philadelphia, the Community Blog caught up with Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health (CDRH) at the FDA. We asked him what he thought about today’s medical device regulatory climate, and where he sees the industry overall headed in the next few years. Hint: Shuren’s optimistic vision for the future of the CDRH embodies the overall theme of everything we do here at the Community Blog - build a community. Our Q&A is included below.
DeNovo Ventures’ Managing Director Joe Mandato speaks with minimally invasive surgery/robotics pioneer Fred Moll, MD. Moll founded three public robotics companies, co-founded Origin MedSystems and Gynecare, and recently raised a record amount of capital for a new device company, Auris Health. Moll is an innovator, entrepreneur, and seasoned board member, and he speaks with Mandato about board governance.
Neuro-focused prescription digital health companies are taking aim at a range of diseases from psychiatric and mental health disorders to neurodegenerative diseases. In this excerpt from our September 28 feature, “Digital Taps Into Neurological Function,” Mark Ratner talks with William Marks, MD, about Verily Life Sciences’ activities in the field.
“Briteseed’s Burgeoning Smart Surgical Tools Stop Unsafe Bleeding.” Chicago-based Briteseed LLC is developing the next generation of smart surgical tools that can provide visual, anatomical information to surgeons in real-time. In addition to improving patient outcomes, Jonathan believes Briteseed could offer significant cost savings for payors and providers impacted by non-reimbursable costs. In this interview, CEO Jonathan Gunn, Phd, JD, talks about his early inspiration and his experiences in co-founding the company, his current priorities, and what’s next for Briteseed.
In this installment of IMH, we take a look at the pioneering early work in intraocular lenses that laid the foundation for the remarkable devices on the market and under development today that are preserving and even restoring vision. We also discuss three important trends to watch in the ophthalmic implant space, according to Andrew Iwach, MD, Executive Director of the Glaucoma Center of San Francisco, and clinical spokesperson for the American Academy of Ophthalmology.