How DarioHealth turned the smartphone into a user-friendly glucose monitor

When DarioHealth (NSDQ:DRIO) CEO Erez Raphael looks at the medical device world, he sees solutions that were designed by healthcare professionals and doctors – and this presents a stark contrast with the consumer device industry, he pointed out. “We have seen there are a lot of cases, most of the cases in the industry, where the […]

FDA approves first pill with sensor to track ingestion

The FDA today approved Abilify MyCite, the first drug in the U.S. to have an ingestible sensor embedded within the pill that can track if the medication was taken. The drug-device combination product is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and as an […]

West Pharma reveals new wearable SmartDose injectors

West Pharmaceutical Services (NYSE:WST) unveiled two new wearable injectors today from its SmartDose drug delivery platform as part of the annual PDA Universe of Pre-filled Syringes and Injection Devices meeting in Vienna, Austria. West’s first-gen SmartDose device is a user-loaded injector designed to deliver high volumes of viscous drug products. Get the full story at our […]

The top 10 medical disruptors of 2018

Each year the Cleveland Clinic determines what the top 10 disruptors in healthcare will be for the following year. The criteria to be considered a disruptor is that it has to be so innovative that it could change healthcare in a significant way in the next year. Approximately 150 to 200 Cleveland Clinic physicians from

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UK design firm touts new device as the ‘Nespresso of auto-injectors’

People living with chronic diseases often have to treat themselves at home using a medical device like an auto-injector. The process can be nerve-wracking, because it requires the patient to follow a number of important steps – like properly storing their drugs and warming them to the correct temperature at the time of injection. These

Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem

Bigfoot Biomedical‘s chief executive is excited about Abbott‘s (NYSE:ABT) latest regulatory win – and it’s not just because the two companies have an established partnership. Yesterday, the FDA approved Abbott’s FreeStyle Libre Flash continuous glucose monitoring system. It’s the first device of its kind, allowing patients to track their blood glucose levels without the use […]

The startup pivot: How to rethink your medical device company

In the medtech market, startups have to be flexible; the startup pivot is crucial. “Companies have to morph as they go,” said Maria Palasis, CEO of bioresorbable drug delivery system company 480 Biomedical. Palasis explained that startups, and even mature companies should expect to shift their technology in one way or another through the course of

Webinar about combination products: Bridging the gap between pharma and medical devices

This webinar was recorded live on Wednesday, October 18, 2017. Click below to watch on demand.     We will provide a new understanding of key topics that separate the regulatory and quality process for drugs and combination products/drug delivery devices.  We understand the process for drug development and certification varies greatly from the process

FDA’s medical gas guidance offers clarity to manufacturers

FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003. A review under FDASIA in 2015 noted that minor guidance updates and better inspector training would improve the regulatory […]

Raumedic to present at CPhl Worldwide

Raumedic will be present at the pharma tradeshow CPhl Worldwide in Frankfurt, Germany, for the first time in several years. The event is scheduled to take place from Oct. 24-26. The company will showcase a variety of polymer products and components to trade show attendees as well as drug delivery systems and packaging solutions. Raumedic

Insulet touts real-world data for Omnipod insulin management tech

Insulet (NSDQ:PODD) touted real-world data today for its Omnipod insulin management system at the Congress of the European Association for the Study of Diabetes. The data come from a study of nearly 39,000 patients with Type I and Type II diabetes who received insulin through the Omnipod system and had at least three months of data […]

Medtronic recalls insulin infusion sets

Medtronic (NYSE:MDT) said today that it’s recalling some of the infusion sets used with its insulin pumps due to problems with a discontinued component. The Fridley, Minn.-based medical device titan said the problem involves a vent membrane that’s susceptible to blockage during priming and fill-tubing. No pumps or glucose sensors are affected by the recall, Medtronic […]

Cells can be programmed into living devices: Here’s how

Synthetic biologists at Harvard University have programmed microbial cells into living devices that can produce drugs, fine chemicals and biofuels and detect disease-causing agents. A team of biologists at Harvard’s Wyss Institute for Biologically Inspired Engineering fit cells with artificial molecular machinery that could sense stimuli like toxins in the environment, metabolite levels and inflammatory

How to ensure adhesion on hard-to-bond plastic substrates

Medical device companies are increasingly using plastic substrates that are tough and sterilization/chemical resistant. But they also come with adhesion challenges. Michelle Gumbert and Patrick Vaughn, Dymax  For medical devices such as catheters, prefilled syringes, vials, test tubes and injector pens, many manufacturers are turning to plastic substrates that are specifically formulated to resist harsh

Manufacturing drug device products: challenges and best practices

Integrating a drug with a mechanical device can, in some cases, improve patient outcomes and boost sales. But manufacturing these products is no simple feat: It often requires a specialized contract manufacturer with extensive experience in the field to make a drug-device combo buildable and scalable. There’s a lot to consider when manufacturing a medical