“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.
gBETA Medtech Accelerator, launched this past March, is the first accelerator of its kind to tap into the rich medical device, digital healthcare, diagnostics and biotech ecosystem that exists in the Midwest Medical Alley region. Its goal is community building, and fostering innovation among the most promising of today’s early-stage start-ups. The program is funded by Boston Scientific, with additional support from Mayo Clinic, University of Minnesota, and Medical Alley Association.
Carbon’s unique 3D liquid interface process creates the products it prints out of a pool of liquid, an approach that it says overcomes the challenges of traditional layering. The well-funded start-up has partnered with big players in numerous industries. Johnson & Johnson invested in its latest financing round, which points toward opportunities in medtech. An excerpt from Editor-in Chief David Cassak’s recent profile of Carbon.
“Conavi: Completing the Picture for Intravascular Imaging.” Toronto-based commercial-stage medical device company Conavi Medical is developing image guidance technologies for use in minimally invasive cardiovascular procedures and is on a mission “to make procedures that are established or emerging safer, faster, and with better outcomes.” In this interview, Brian talks about his inspiration and early experiences in founding the company, his current priorities, and what’s next for Conavi.
NASS, the year’s biggest spine surgery gathering, begins next week in Los Angeles amid a hot medtech financing market and tides of disruption—if a slow-shifting market like spine can be disrupted. We’ve put together a crib sheet on the key trends in M&A and R&D we will be watching for at the meeting, based on interviews in recent months with leading spine surgeons, analysts, and industry execs.
In this week’s edition of “In MedTech History,” we highlight recent developments in the brave new world of automated diabetes devices, including Tandem Diabetes Care’s US launch of its t:slim X2 Insulin Pump with predictive Basal-IQ Technology. Advancements such as these couldn’t be coming at a more opportune time: Diabetes is now the most costly chronic illness in the US, according to the American Diabetes Association.
The evolution in device-based diabetes management began more than 50 years ago. Today, fueled by US healthcare costs approaching $330 billion and exponential global growth in incidence and prevalence, device technologies—powered by the promise of data and analytics—are helping to simplify the lives of diabetic patients and at the same time combat the rise in the cost of care. In this edition, we take a look at DexCom’s acquisition of TypeZero Technologies.