• German Court Crowns Edwards with Shared Tiara Rights

    Neovasc said it will appeal a ruling that partially favored Edwards in a European patent dispute.Amanda PedersenThe CardiAQ device is threaded into the heart from below. Vancouver-based Neovasc said it will appeal a German court ruling that partially favored Irvine, CA-based Edwards Lifesciences Corp. in a European patent dispute.The District Court in Munich found that CardiAQ Valve Technologies Inc., which is now part of Edwards, contributed to the invention of Neovasc’s Tiara mitral...
  • Will an Ultrasound Drill Solve Deep Vein Blood Clots?

    Researchers are developing a tool that uses low-frequency intravascular ultrasound waves to break down blood clots that cause deep vein thrombosis.Kristopher Sturgis p.p1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 14.0px Helvetica; color: #666666; -webkit-text-stroke: #666666} span.s1 {font-kerning: none} This ultrasound “drill” can be aimed straight ahead to better target clots. The tool also incorporates an injection tube that allows users to inject microbubbles at the site of the clot, making...
  • Some Surgical Nav Systems are Error-Prone, FDA Warns

    p.p1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 14.0px 'Helvetica Neue'; color: #323333; -webkit-text-stroke: #323333} span.s1 {font-kerning: none} FDA issued a safety warning regarding possible navigational accuracy errors linked to frameless stereotaxic navigation systems, although the agency said the overall benefits of using these systems continue to outweigh the risks. Amanda Pedersen   Certain types of stereotaxic navigation systems could produce accuracy errors,...
  • 4 Life Lessons from a Medtech Pioneer

    Robert E. Fischell, PhD, winner of the 2017 MDEA Lifetime Achievement Award, shared some of the wisdom he has gained from more than 50 years in the medical device business during MD&M East this week.Amanda Pedersen   After more than 50 years in the medical device business, and securing more than 200 patents, Robert E. Fischell, PhD, has gained a wealth of knowledge about innovation. On Tuesday, during a presentation at the MD&M East conference and expo in New York,...
  • Liquidmetal Wins Innovation Prize

    Liquidmetal was voted in as the Innovation Prize winner at MD&M East 2017.Liquidmetal’s Matt Martin demonstrated the strength and elasticity of components made through the one-step molding process.Liquidmetal from Liquidmetal Technologies has won the Innovation Prize at MD&M East 2017. Combining a novel material with a unique shape-forming process, the Liquidmetal solution can be used to create high-strength metal components with little to no shrinkage. Specifically, the amorphous, non-...
  • Phillips-Medisize: Molex Merger Has Been a ‘Win-Win’

    Several months after merging with Molex, Phillips-Medisize points to the benefits of the combination, including vertical integration, added electronics capabilities, and a faster time to market.Marie ThibaultGame changer.That’s how an executive for Phillips-Medisize Corporation describes the company’s acquisition by Molex, LLC in late October 2016.Phillips-Medisize, a major provider of outsourced design and manufacturing services for the medical device, diagnostic, and pharmaceutical industries...
  • Trauma Care Eased with New Package

    Two trauma wounds could be sealed in emergency settings.Daphne AllenH&H DualSeal pack provides the ability to cover two wounds without carrying a larger pouch.Seconds count when professionals are treating trauma patients in the field. Having developed life-saving emergency-care products for more than 30 years, H&H Medical Corp. has found yet another way to expedite trauma treatment—include two chest dressings in one easy-to-use package.H&H has launched the DualSeal occlusive chest...
  • U.S. Hip Arthroscopy Market Shaped by Innovation and Increased Interest

    The U.S. market for hip arthroscopy is undergoing significant growth in response to technological innovation and changes in the competitive landscape. Matthew Choi and Jeffrey WongHip arthroscopy is a minimally invasive procedure commonly performed to treat femoralacetabular impingement (FAI) and labral tears. The number of people affected by FAI and labral tears is currently unknown due to a lack of proper diagnostic tools and the fact that most conditions remain asymptomatic.1 The U.S. market...
  • This Study Could Be Huge for Women Needing EVAR

    Endologix reported positive 30-day results from a study evaluating endovascular aneurysm repair in women, using a device specifically designed to better suit female anatomy compared to traditional treatment options.Amanda PedersenEndologix said its Ovation System was specifically designed to better suit female anatomy compared to traditional endografts. Underrepresentation of women in clinical trials is one of the biggest hurdles cardiovascular researchers face when evaluating a new device...
  • Will Superior FDA Labeling Ease Hologic Investor Concerns?

    FDA approved a new label for Hologic’s Genius 3-D mammography technology, designating it as being superior to standard 2-D mammography for routine best cancer screening of women with dense breasts. It is the first system of its kind to recieve such labeling.Amanda PedersenHologic's Genius 3D Mammography system won FDA approval in 2011, but a newly approved physician label gives the system supier status over standard 2-D mammography for routine breast cancer screenings of women with dense...
  • Is Rumored Valeant Deal Giving You Déjà vu?

    Rumor has it the debt-ridden company is looking to sell its Bausch + Lomb surgical product assets to Carl Zeiss Meditec for as much as $2 billion, but Valeant has a track record of talking about more deals than it completes.Amanda Pedersen The deal rumor mill is hot this week with reports that Valeant Pharmaceuticals may be looking to sell its Bausch + Lomb surgical product assets to Carl Zeiss Meditec. Neither company has commented publically on the potential deal.Learn about product...
  • Bos Sci Wins CE Mark for MR-Conditional DBS System

    The company said its Vercise Gevia deep brain stimulation (DBS) system is the industry’s first MR-conditional directional DBS system with stimulation visualization.Kristopher Sturgis  Boston Scientific’s Vercise deep brain stmulation (DBS) system is intended for the treatment of movement disorder symptoms in patients with Parkinson’s disease, dystonia, and essential tremor. The recent CE mark applies to the newest version of this technology, the Vercise Gevia DBS system. This...
  • What Caused Magellan’s Lead Test Problem? FDA is Stumped

    FDA has not been able to identify the root cause of Magellan's inaccurate lead test results, and the recall has been expanded to include two additional testing systems.Amanda PedersenFDA is conducting studies with the CDC to identify the cause of Magellan's faulty blood-based lead tests. Magellan Diagnostics expanded its ongoing recall to include two additional testing systems, the LeadCare and the LeadCare II, because they may underestimate the blood lead levels (BLL) and give inaccurate...
  • 5 Emerging Challenges in Surface Treatment

    Advances in medtech are giving those involved in surface coating a few new issues to consider.Daphne AllenHarland’s FTS 6000 Friction Test System measures both surface friction and coating durability.The bar is being raised for surface treatment in medical device manufacturing. Surfaces have typically been coated or treated to enhance product lubricity and durability, but new trends in medical device manufacturing could present some challenges.For instance, new “multimaterial devices with as...
  • Point-of-Clinic Diagnostics: Shaping the Future for Improved Patient Outcomes

    There is a growing demand for economically viable and flexible diagnostic tools that swiftly deliver accurate results. Dr. Giles SandersTTP’s Desktop Biology service enables diagnostic providers to rapidly convert their biological assays into market-ready point-of-clinic systems capable of producing a result in as little as 15 minutes.Point-of-care diagnostics have been on the cusp of full-scale adoption for the past few decades, but apart from a few cases, this has proven...
  • FDA Clears Debris-Catching Device for TAVR

    Claret Medical said its Sentinel device reduces strokes by 63% in the first 72 hours after TAVR.Amanda PedersenFDA cleared Claret Medical's Sentinel Cerebral Protection System for use during TAVR procedures, following positive input from an FDA advisory panel in March. Transcatheter aortic valve replacement (TAVR) should be safer for U.S. patients, now that FDA has cleared a device designed to catch and remove loose debris before it reaches the brain. Santa Rosa, CA-based Claret Medical...
  • Using Rapid Manufacturing to Mitigate Design Risk in Overmolding and Insert Molding

    Confirming your part design can be molded early in the design process can help reduce risks.Daphne AllenAn insert-molded part with a brass insert. Image courtesy of Proto Labs.Overmolding and insert molding are well established processes for combining two different materials in the same finished part. Such molding techniques are commonly used in medical device manufacturing, but there are still some “unseen risks,” reports Becky Cater, global product manager for injection molding at ...
  • How to Get to the Heart of Stem Cell Delivery

    A new study showed that stem cell delivery using BioCardia’s Helix system resulted in up to 18 times better heart tissue retention of stem cells compared to some standard methods.  BioCardia had its work cut out for it when the company entered the cardiovascular regenerative medicine space. Delivering stem cell therapies into a moving heart – and keeping them there – is inherently difficult. But the San Carlos, CA-based company was up to the challenge, and designed a delivery system...
  • Harmful Chemicals in Spine Implants Prompt Zimmer Recall

    Zimmer Biomet recalled two implantable spinal fusion stimulators after a routine cytotoxicity test indicated high levels of chemicals that could be toxic to tissues or organs.Amanda PedersenZimmer Biomet is recalling its SpF PLUS-Mini and SpF XL llb implantable spinal fusion stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues or organs. The company initiated the recall on April 20 after discovering the problem during routine monitoring,...
  • Reusable Devices: How Effective Is Your Cleaning Validation?

    If you're developing a medical device that will be reprocessed, you've got a lot to consider.Daphne AllenAlpa Patel, B.S. RM (NRCM)Developing a cleaning validation for a reusable medical device presents several challenges. How are you addressing them?“There have been many issues over the last 7 years, so there’s increased scrutiny of cleaning validations,” explained Alpa Patel, B.S. RM (NRCM) of Nelson Laboratories. “FDA published the 2015 guidance, ‘Reprocessing Medical Devices in Health Care...