LEAD STORIES

Abbott Reaches Deals With Heart Valve Companies Tendyne, Cephea

In separate transactions, Abbott Laboratories has agreed to buy Tendyne Holdings, Inc. for $250 million, and to provide an undisclosed amount of capital for Cephea Valve Technologies. Both privately-held companies are developing devices that would complement Abbott's own portfolio of mitral valve replacement therapies.

  • FDA Approves Non-Surgical Balloon Device To Treat Obesity
    FDA Approves Non-Surgical Balloon Device To Treat Obesity

    The U.S. Food and Drug Administration (FDA) on Tuesday approved the first intergastric balloon device for obesity treatment available in the United States. The ReShape Integrated Dual Balloon System is minimally invasive, reversible, and appropriate for patients with a body mass index (BMI) between 30 and 40 kg/m2 who do not qualify for bariatric surgery. However, while early studies look promising, experts urge caution until there is data to support the effectiveness of the device long-term.

  • Mayo Clinic LVAD Study Suggests Market Expansion
    Mayo Clinic LVAD Study Suggests Market Expansion

    A recent Mayo Clinic study shows improved survival rates in patients with end-stage restrictive cardiomyopathy (RCM) who received left ventricular assist devices (LVADs). The potential to treat more heart failure patients could expand the market for LVADs, which currently are used in the treatment of other types of cardiomyopathy, either as a bridge to transplant (BTT), or as a destination therapy (DT).

INDUSTRY PERSPECTIVES

  • Wearables: The Promise And Peril For Medtech Companies
    Wearables: The Promise And Peril For Medtech Companies

    From smart clothing to wristwatches, wearables that extract biological data are pouring into the digital health domain. Major consumer electronics companies are joining established and emerging medical device companies in launching these wearable technologies, and traditional medical device companies’ success will be measured by how well they help to prove outcome value, as well as how seamlessly they can integrate into patients’ daily, wired lives.

  • The Impact Of Large-Scale Mergers On The European Extremity Reconstruction Industry
    The Impact Of Large-Scale Mergers On The European Extremity Reconstruction Industry

    The small bone and joint device market in the Europe consists of reconstructive implants for the extremities, including the shoulder, elbow, hand, and foot. Significant growth in unit sales of key segments is counteracting across-the-board price cuts that are caused by competition and tendering processes in many EU countries. These price declines are causing many niche markets in extremity reconstruction to shrink, despite otherwise stable unit sales. However, there still is significant potential for growth.

  • Implementing UDI Direct Marking
    Implementing UDI Direct Marking

    Direct marking is one part of FDA’s Unique Device Identification (UDI) rule, and it has a set of compliance dates that may differ from the labeling and Global UDI Database (GUDID) submission dates. The recently published draft guidance document Unique Device Identification: Direct Marking of Devices restates some requirements for direct marking and clarifies some issues. The UDI system has three major elements: adding a UDI to the product , loading a large dataset to FDA’s public database (the GUDID), and updating the quality system procedures.

More Industry Perspectives

FROM THE EDITOR

  • New Insights On Med Device Market Consolidation
    New Insights On Med Device Market Consolidation

    If your company is considering M&A as a solution to the med device market pressures, you need to understand the challenges ahead. I sat down recently with Steve Cottrell, the new president of Maetrics Life Sciences Consulting, to discuss his thoughts on the issue.

  • Companies To Watch: Pulse Therapeutics
    Companies To Watch: Pulse Therapeutics

    Pulse Therapeutics has developed a mechanical thrombolysis technology that accelerates the delivery of clot-busting drugs to a clogged artery. The Magnetically Enhanced Diffusion (MED) System consists of intravenously administered nanoscale iron particles and a patient-side workstation, whose rotating magnet induces the particles to spin within the bloodstream. This activity creates flow towards the clot in otherwise stagnant vessels, bringing medications to the clot site 40 times faster than normal. The company has filed an early feasibility investigational device exemption (IDE) with the FDA, and anticipates beginning clinical trials to evaluate the device for stroke treatment later this year.

  • 3 Top Trends Driving Medical Device Design In 2015 — Experts Weigh In
    3 Top Trends Driving Medical Device Design In 2015 — Experts Weigh In

    What factors should you consider before designing your next medical device? What capabilities will end users request (or demand?) from new devices in the coming months? What design approaches are your peers taking? What types of designs will be successful in the future?

More From The Editor

WHITE PAPERS & CASE STUDIES

  • Beyond Compliance: Medical Device Product Development

    Increased regulatory scrutiny is a reality in today’s medical device industry. Over the last several years many of the industry’s leading companies have been hit with an injunction, undergone a product recall, or found themselves operating under FDA consent decree. At the same time, the pressure for growth on these companies has never been greater. Driven by Wall Street, the pace of new technology, emerging market opportunities, and competition from well funded start-ups, medical device executives find themselves in an environment where they must continually innovate with flawless execution to survive.

How The Internet Of Things Is Revolutionizing Healthcare

In the Internet of Things (IoT), devices gather and share information directly with each other and the cloud, making it possible to collect, record and analyze new data streams faster and more accurately. By David Niewolny, Healthcare Segment Manager, Freescale Semiconductor

5 Tips To Help Your FDA 510(k) Submission (Checklist Included)

If you are developing a medical device in the United States, there is a good chance your path to market involves a FDA 510(k) submission. Within the past year, I’ve had the pleasure of authoring a couple FDA 510(k) submissions on my own from scratch, and I have learned a ton from these experiences. FDA expectations for 510(k)s are dramatically different from when I started my career. Let me share some things I’ve learned.

The Multiplier Effect Of Drug-Device Convergence

First-generation drug-device pioneers could not have envisioned today’s landscape. The growing convergence between medical devices, pharmaceuticals, and biologics is transforming these once-separate market sectors, not to mention the state of health care and our quality of life. The global market for drug-device combinations is on track to generate $115 billion in market value by 2019. Thus, opportunity — and demand — abounds for effective treatments combined with innovative drug delivery methods.

Adhesives For Gentle Removal From Skin

Berry Plastics has developed a new medical pressure sensitive adhesive (PSA) and tape designed to reduce pain from removal on a variety of different skin types. This white paper describes information about the PSA, the testing process for gentle skin removal, and its testing for strong adhesion.

More White Papers & Case Studies

PRODUCT SHOWCASE

Direct Metal Laser Sintering (DMLS) for Additive Manufacturing

Direct Metal Laser Sintering (DMLS) for Additive Manufacturing

In direct metal laser sintering, a laser draws onto the surface of atomized powder to build production-quality metal parts. The process produces metal parts with the same speed as plastic parts, and it can transition into metal injection molding.

Thick Film Stainless Steel Heaters

Thick Film Stainless Steel Heaters

Heatron’s thick film stainless steel heaters are ideal for applications that call for heating solutions up to 650oC. They can be machined into complex shapes and forms and are well suited for DNA analysis, dialysis, blood diagnostics, surgical devices, sterilization, MRI equipment, and other medical applications.  

Ethylene Oxide (EO) Sterilization of Medical Devices

Ethylene Oxide (also known as EO or EtO) sterilization is a simple chemical compound that is commonly used for gaseous sterilization of disposable medical devices and healthcare products. A wide variety of materials and components commonly used in the manufacture of these products may undergo ethylene oxide sterilization in their final breathable packaging configuration.

High-Temperature Injection Molding

High-Temperature Injection Molding

High temperature plastic resins provide physical and dimensional stability and excellent elasticity. They’re resistant to harsh chemicals and hydrolysis and feature exceptional electrical properties and low flame and smoke toxicity.

Surface Treatment

Surface Treatment

Carclo Technical Plastics supplies a wide range of coatings and treatments to the surface of plastic components to impart special properties, decoration, improved wear, and increased performance.

Alcotabs: Critical-Cleaning Detergent Tablets

Alcotabs: Critical-Cleaning Detergent Tablets

Special slow release tablet formulation for maximum cleaning performance from your syphon pipette washers. Concentrated to save you money. Biodegradable and readily disposable. Free rinsing to give you reliable results and no interfering residues. Use to pass your cleaning validation tests for lab accreditation and plant inspection approval.
More Featured Products
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LATEST HEADLINES

  • Abbott Reaches Deals With Heart Valve Companies Tendyne, Cephea
    Abbott Reaches Deals With Heart Valve Companies Tendyne, Cephea

    In separate transactions, Abbott Laboratories has agreed to buy Tendyne Holdings, Inc. for $250 million, and to provide an undisclosed amount of capital for Cephea Valve Technologies. Both privately-held companies are developing devices that would complement Abbott's own portfolio of mitral valve replacement therapies.

  • CERN Miniaturizes Linear Accelerator For Medical Applications
    CERN Miniaturizes Linear Accelerator For Medical Applications

    Scientists from the European Organization for Nuclear Research (CERN) have taken the technology used to create the Large Hadron Collider (LHC) and made it small enough to be installed in hospitals. A miniature linear accelerator (mini-Linac), said developers, could be used for future cancer treatments, as well as the production of radioisotopes used in medical imaging and sterilization of medical equipment.

  • Proto Labs Launches Rapid Magnesium Injection Molding Service

    Proto Labs, Inc. recently introduced its new magnesium injection molding into its current rapid manufacturing services. The new injection molding process allows designers to prototype using the same materials and processes used for the final part production.

  • Amendia Continues To Expand By Acquiring The Business Of Custom Spine

    Amendia Inc. announced that it has acquired the business of Custom Spine, Inc. Since 2003, Custom Spine, a New Jersey-based company, has developed an extensive portfolio of new generation, surgeon-friendly spinal technologies. The Custom Spine transaction is a new milestone for Amendia, ideally positioning the company for sustainable and scalable growth.

  • Colonoscopies Of The Future: Adjustable-Focus Endoscope Helps To Reduce Discomfort
    Colonoscopies Of The Future: Adjustable-Focus Endoscope Helps To Reduce Discomfort

    Researchers from the National University of Singapore have created an endoscopic probe that delivers adjustable-focus capabilities in a slimmer package. Their findings, published this week in the journal Optics Express, published by The Optical Society, could ultimately facilitate more effective and less painful imaging of internal tissues.  

  • Lombard Medical Acquires Endovascular Stent Graft Developer Altura Medical

    Lombard Medical, Inc.has announced the acquisition of Silicon Valley-based Altura Medical, a privately-held, venture-backed company that has developed an innovative ultra-low profile endovascular stent graft technology that offers a simple and predictable solution for the treatment of standard AAA anatomies.

  • J&J, Google Joint Robotics Venture Approved By India’s Fair Trade Body
    J&J, Google Joint Robotics Venture Approved By India’s Fair Trade Body

    The Competitive Commission of India (CCI) has approved a proposed joint venture between medtech multinational Johnson & Johnson and tech giant Google to develop a surgical robotics platform. Google will provide software, sensor, and imaging technology to help J&J develop new robotic surgery products, allowing the companies to compete with pioneer Intuitive Surgical's da Vinci robotic surgery platform

More News

UPCOMING TRAINING COURSES

Project Management: Best Practices for Validation & Regulatory Projects

August 5, 2015
1pm-2:30pm EDT, Online Training

Medical Device Complaint Handling and MDR Reporting

August 11, 2015
1pm-2:30pm EDT, Online Training

Cloud Computing In A GxP Environment: Three Key Success Factors

August 13, 2015
1pm-2:30pm EDT, Online Training

21 CFR Part 11: Understanding the ERES Regulation for Compliance Success

August 25, 2015
1pm-2:30pm EDT, Online Training
More Upcoming Courses

FEATURED SUPPLIERS

Promed Molded Products Inc.

Promed Molded Products Inc.

ProMed was founded in 1989 to address an industry need for cleanroom molding of silicone components, primarily those having a medical application. The company has expanded its capabilities over the years and now offers silicone molding along with micro-molding of highly engineered plastics and drug eluting / combination products. From a single component to complete devices, ProMed has the resources, quality systems and facilities to meet most dimensional and cosmetic print specifications and comply with rigorous industry standards.