Thermo Fisher Scientific To Acquire FEI Company
Thermo Fisher Scientific Inc., the world leader in serving science, and FEI Company, the leader in high-performance electron microscopy, recently announced that their boards of directors have unanimously approved Thermo Fisher’s acquisition of FEI for $107.50 per share in cash. (Source: Medical Design Online News)
Source: Medical Design Online News - June 1, 2016 Category: Medical Equipment Source Type: news
Philips Launches Remote Care Solution For Seniors, Investigates At-Home Care Platforms For MCI Patients
Philips has partnered with at-home senior care provider Right at Home to commercially launch CareSensus, a biosensor platform that can work together with in-home care services to offer a blended and more affordable approach to senior living. The solution is expected to offer 24/7 monitoring that adjusts to the individual’s needs, and advanced analytics that could detect a potential problem earlier than the objective observation of a caregiver. (Source: Medical Design Online News)
Source: Medical Design Online News - May 31, 2016 Category: Medical Equipment Source Type: news
Baxter Unveils Innovative THERANOVA Dialyser At 2016 ERA-EDTA Congress
Baxter International Inc. (NYSE:BAX), a leading provider of dialysis therapies, previewed THERANOVA, a new class of dialysers1,2 with the potential to significantly advance renal care, at the 53rd Congress of the European Renal Association and European Dialysis and Transplant Association (ERA-EDTA). (Source: Medical Design Online News)
Source: Medical Design Online News - May 31, 2016 Category: Medical Equipment Source Type: news
FDA Approves Buprenorphine (Probuphine) Implant For Opioid Replacement Therapy
Probuphine – a first-of-its-kind buprenorphine implant for use by those dependent on opioids – has received approval from the FDA. The same drug has previously been available both as a pill form and as a film that dissolves under the tongue. Proponents of Probuphine, which was developed by Titan Pharmaceuticals and Braeburn Pharmaceuticals, say that the implant offers a host of advantages over other delivery methods. (Source: Medical Design Online News)
Source: Medical Design Online News - May 31, 2016 Category: Medical Equipment Source Type: news
Outsourcing Insights For Drug Delivery Devices
Windgap Medical's wet/dry epinephrine delivery device is in its third generation of prototype development, and the company has fought through the gauntlet of outsourcing decisions. Here, CEO Chris Stepanian discusses outsourcingmethodology, including which functions to outsource, vetting of potential partners, and more. (Source: Medical Design Online News)
Source: Medical Design Online News - May 31, 2016 Category: Medical Equipment Source Type: news
Diabetes Technology Society Unveils Cybersecurity Standard For Diabetes, IoT Devices
The nonprofit Diabetes Technology Society (DTS) unveiled recently a cybersecurity standard called DTSec, designed for interconnected diabetes devices, such — as continuous glucose monitors (CGM), wireless insulin pumps, and closed loop systems — as cybersecurity threats loom large in the medtech and healthcare sectors. (Source: Medical Design Online News)
Source: Medical Design Online News - May 31, 2016 Category: Medical Equipment Source Type: news
World Health Organization (WHO) Unveils Global Regulatory Framework For Medical Devices
The World Health Organization (WHO) has released a draft proposal for its global regulatory framework for medical devices and in vitro diagnostics (IVDs). (Source: Medical Design Online News)
Source: Medical Design Online News - May 27, 2016 Category: Medical Equipment Source Type: news
EU Reaches Accord On New Medical Device, In Vitro Diagnostics Regulations
The Council of the European Union (EU) and representatives of the European Parliament have agreed on two long-awaited draft regulations on medical devices and in vitro diagnostics (IVDs). The text documents were not made available, but the Council says the drafts were deliberated upon to make sure that medical devices and IVDs in Europe are safe while allowing patients to benefit from innovative health care solutions in a timely manner. (Source: Medical Design Online News)
Source: Medical Design Online News - May 27, 2016 Category: Medical Equipment Source Type: news
Kalorama: Global Medical Device Market Reaches $381B
According to Kalorama Information, the world market for medical devices reached $381 billion in 2015. Though these are challenging times in the market, there is still plenty of opportunity for success for companies that remain optimistic and seek innovation. (Source: Medical Design Online News)
Source: Medical Design Online News - May 27, 2016 Category: Medical Equipment Source Type: news
Medical Device Innovation Consortium Announces Release Of Draft Blueprint For Early Feasibility Study Success
Recognizing the strategic advantages of conducting Early Feasibility Studies in the US, the Medical Device Innovation Consortium (MDIC) sought to develop a Blueprint for Early Feasibility Study Success, a best practices guidelines for planning and executing US-based Early Feasibility Studies. (Source: Medical Design Online News)
Source: Medical Design Online News - May 27, 2016 Category: Medical Equipment Source Type: news
Senate Bill Would Streamline CMS's Process For Breakthrough Technologies
Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement after introduction of legislation in the U.S. Senate, S. 2998, to expedite CMS decision-making for innovative medical technologies: (Source: Medical Design Online News)
Source: Medical Design Online News - May 27, 2016 Category: Medical Equipment Source Type: news
05.28.16 -- MDO's Top Stories This Week
05/28/16 MDO's Top Stories This Week (Source: Medical Design Online News)
Source: Medical Design Online News - May 26, 2016 Category: Medical Equipment Source Type: news
Medtronic, Qualcomm Join Forces To Develop Continuous Glucose Monitors
Medtronic and Qualcomm will collaborate on the development of future-generation continuous glucose monitoring (CGM) systems for diabetics, starting with a single-use CGM device that will utilize a new, smaller sensor that monitors blood glucose levels in real-time, helping general practitioners caring for patients with type 2 diabetes. (Source: Medical Design Online News)
Source: Medical Design Online News - May 26, 2016 Category: Medical Equipment Source Type: news
FDA Panel Votes 15-1 To Approve St. Jude's Stroke Prevention Device
An FDA panel has issued the green light for St. Jude’s Aplatzer PFO Occluder device, saying studies of the device showed “reasonable assurance” that the device was safe for use. The implant, which is intended to prevent recurrent ischemic strokes in patients with patent foramen ovale (PFO), has been the subject of controversy for decades, and the panel’s decision represents a major milestone for the technology, said St. Jude executives. (Source: Medical Design Online News)
Source: Medical Design Online News - May 26, 2016 Category: Medical Equipment Source Type: news
Vectura And Propeller Health Announce Collaboration To Develop Digitally-Connected Inhalers To Address Chronic Respiratory Diseases
Vectura Group plc (LSE: VEC) and Propeller Health, the leading digital health solution for respiratory medicine, today announced a collaboration to develop inhalers that combine Vectura's proven dry powder inhaler ("DPI") technology with Propeller's FDA-cleared digital health platform. (Source: Medical Design Online News)
Source: Medical Design Online News - May 26, 2016 Category: Medical Equipment Source Type: news
