When Pat Sullivan joined Insulet (NSDQ:PODD) in 2014, the Billerica, Mass.-based company was reeling in roughly $300 million in revenue selling its Omnipod tubless insulin delivery system. Sullivan, a veteran of the medtech industry, saw a path to creating a billion-dollar company and it centered around the concept of making life easier for people with diabetes. “I
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ElectroCore announced that it has launched its gammaCore Sapphire non-invasive vagus nerve stimulator in the U.S. The device is the first non-invasive vagus nerve stimulator device to be cleared by the FDA for acute treatment of pain from migraines and episodic cluster headaches. The gammaCore Sapphire device is portable and easy-to-use and can be self-administered
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NuVasive (NSDQ:NUVA) said yesterday it inked a strategic partnership deal with Siemens (NYSE:SI) Healthineers looking to develop and advance technology designed for minimally invasive spinal surgery. Through the deal, dubbed the Spine Precision Partnership, the companies will look to jointly advance their proprietary technologies, looking to improve operating room workflow efficiency and the delivery of minimally disruptive spinal technologies,
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Hologic (NSDQ:HOLX), known in the medtech industry for its mammography and diagnostics devices, is rethinking what it means to be a women’s healthcare company. The 6,000-person company wants to expand its reach to include products that care for women’s well-being, as well as their health – a concept that Dr. Edward Evantash honed when he led
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Chemical engineers from Massachusetts Institute of Technology have developed a sensor that could help doctors determine what the best cancer treatment option is based on how cells react to different types of chemotherapy drugs. The sensors are designed to detect hydrogen peroxide in human cells, which could help researchers determine new cancer drugs that increase
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Robert Lee, president, Particle Sciences; Nick DiFranco, marketing specialist, Particle Sciences Poor water solubility is an increasingly common issue in pharmaceutical development. About 40% of marketed drugs and as many as 90% of active pharmaceutical ingredients (APIs) in the discovery pipeline are poorly water-soluble. When these APIs are introduced without modification or enhancement, they fail
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The FDA has slapped SpaceLabs Healthcare with a Class 1 recall of its Arkon anesthesia delivery system for going into a “failed state” on numerous occasions since 2013. The recall covers 253 units. No injuries or deaths were reported. During the failed state, the mechanical ventilation function stops working while the machine is in use
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More than 98% of the 161 foot and ankle devices that were recalled from 2007 through 2017 were approved through the FDA’s 510(k) process, according to a new study. That left one recalled device approved via the more stringent premarket approval (PMA) process and two for which the submission procedure was not indicated. The 510(k) process
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People may like mobile blood pressure apps better when the apps reveal positive results, even if those results are inaccurate 80% of the time, according to a recent study. A team of researchers who previously revealed the inaccuracy of the Instant Blood Pressure (IBP) app returned to the topic to study 81 adults who compared the
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The Dept. of Health and Human Services’ Biomedical Advanced Research and Development Authority and Johnson & Johnson‘s (NYSE:JNJ) Janssen R&D are launching a new crowdsourced tech development challenge looking to support innovative respiratory protection devices, according to a recently listed government posting. The new contest, dubbed the QuickFire Challenge, will look to award up to
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Avinger (NSDQ:AVGR) today posted a second-quarter losses-per-share that missed an analyst’s expectation, sending its share price down on Wall Street despite nearly halving its losses. The Redwood City, Calif.-based medical device maker reported losses of -$6.6 million, or -98¢ per share, on sales of $2.1 million for the three months ended June 30, 2018. That compares with
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Researchers from the Center for Nanoparticle Research at the Institute for Basic Science have developed a wearable and implantable device that measures electrophysiological signals and stimulates as needed for pain relief, rehabilitation and prosthetic motor control. The soft implantable recorded cardiac activity in multiple points of a swine heart in tests. The researchers on the
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Wednesday, August 29, 2018 11:30am Eastern / 8:30am Pacific What three crucial business questions should you be asking before deciding on a custom connector assembly for your device? What business and technical strategies should you consider before making critical connector decisions? Join us in this live webinar as custom connector industry experts from
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After Basil Leaf Technologies won the Qualcomm Tricorder XPrize in 2017, founder Dr. Basil Harris needed help figuring out how to bring this almost-all-in-one diagnostic tool to market. Basil Leaf’s mobile platform DxtER includes a group of non-invasive sensors that can wirelessly communicate with a smart device as they collect data on vital signs, body
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When selecting a Coreless Brush DC Motor for an application, there are several basic motor physics principles to consider to produce a safe, well-functioning, sufficiently-powered precision drive system. In this guide, we’ve provided important methods, formulas & calculations to determine power output of a coreless motor, the speed-torque curve, the current and efficiency plots, and
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By Medidata Solutions As big data grows and competition rises, stricter regulatory guidance looms Today’s medical device industry is being transformed by the generation and analysis of vast amounts of data. However, the traditional approaches to data collection and analyses in clinical trials don’t necessarily apply. Along with this massive volume of siloed, disparate
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A recent study about recalls of foot and ankle implants included a portion that likely drew less attention than the headline. Some of these implants were recalled because they arrived at the hospital in an unsterile condition, and the authors said faulty packaging may have been the cause. Poor packaging can cause a host of
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Hologic (NSDQ:HOLX) has inked an agreement between its Cynosure division and Porter Instrument to distribute Porter’s nitrous oxide and oxygen system, Nitronox, in the United States and Canada. Nitronox is a self-administered nitrous oxide and oxygen delivery system that provides a fast-acting inhaled analgesic to help patients manage discomfort and anxiety while remaining alert and
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FDA head Scott Gottlieb said that over the past 10 years there have been “far too few” devices hitting the US market designed specifically for a pediatric population, according to a recently posted Regulatory Affairs Professionals report. The statement came at a two-day FDA workshop this week, according to the report. Read the whole story on
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The FDA has approved SPR Therapeutics’ (Cleveland) Sprint endura (single lead) and extensa (dual lead) peripheral nerve stimulation (PNS) systems. The minimally invasive Sprint system is the only FDA-approved percutaneous PNS system that is indicated for up to 60 days in the back and/or extremities for both chronic and acute pain and is the industry’s only
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