Latest Headlines

  1. BioTelemetry Offers To Acquire LifeWatch For $257 Million

    BioTelemetry, Inc. is extending a tender offer to acquire all outstanding shares of rival cardiac monitoring company LifeWatch AG for an estimated total transaction value of 260 million Swiss francs (U.S. $257 million).

  2. FDA Clears Ventec's Five-In-One Portable Respiratory Device

    The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Ventec Life Systems' VOCSN, a portable respiratory system that combines five separate medical devices — a ventilator, oxygen concentrator, cough assist system, suction, and nebulizer.

  3. NHS England To Commission Mechanical Thrombectomy For Stroke Treatment

    The National Health Service (NHS) in England will soon be commissioning mechanical thrombectomy services at 24 neuro centers around the country, which is expected to expand access to over 8,000 NHS patients in the coming years.

  4. Philips’ Intellisite IS First Digital Pathology Solution Gain FDA Clearance For Primary Diagnostic Use In U.S.

    Royal Philips, a global leader in health technology, recently announced  it has received regulatory clearance (via De Novo classification) from the U.S. Food and Drug Administration (FDA)  to market its IntelliSite Pathology Solution, a comprehensive digital pathology system designed to meet the challenges of today’s pathology lab.

  5. FDA Approves Siemens “Single Room” CT Platform With Tablet-Based Automated Workflow

    Siemens Healthineers has announced FDA clearance of its Somatom go. CT platform — including the go.Now and go.Up models — which allows technicians to control the equipment via tablet in the same room as the patient.

  6. IMDRF Guideline Seeks To Unify Adverse Event Terminology, Coding

    The International Medical Device Regulators Forum (IMDRF), a voluntary group of international medical device regulators, has released a final document containing harmonized terminology for reporting adverse events, with matching alpha-numeric codes and examples for medical devices and in vitro diagnostics (IVDs) in both premarket and postmarket settings.

  7. United Orthopedic Corp.’s Polyethylene Knee Insert Cleared By FDA

    United Orthopedic Corporation (UOC), a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments, today announced that the U.S. Food and Drug Administration (FDA) cleared its E-XPE™ polyethylene knee insert.

  8. FDA Clears Entellus Medical’s ENT Dilation System For Eustachian Tube Indication

    Entellus Medical, Inc. (NASDAQ:ENTL), a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis patients, today announced the Company has received 510(k) clearance from the United States Food and Drug Administration (FDA) for use of its XprESS ENT Dilation System in patients with persistent Eustachian tube dysfunction (ETD).

  9. Toyota Launches Rental Service For The Welwalk WW-1000 Rehabilitation Assist Robot In Japan

    Toyota Motor Corporation will launch a rental service for the Welwalk WW-1000 robot from the fall of 2017.

  10. House Subcommittee Urges Healthcare Industry To Partner With Government On Cybersecurity

    The Subcommittee on Oversight and Investigations, part of the U.S. House of Representatives Committee of Energy and Commerce (CEC), held a hearing to discuss strengthening cybersecurity in the healthcare sector by facilitating public-private relationships that are used to secure other industries, such as financial and automotive.