February 26, 2024
Via: MedTech DiveLast week, Medtronic said it would shut down its ventilator product lines and reorganize the remaining patient monitoring and respiratory interventions businesses into a new unit, called Acute Care and Monitoring. The decision reverses a planned spin-off of the businesses […]
February 14, 2024
Via: Electronics WeeklyThe HoC promises to replace animal testing, shorten drug development timelines and reduce costs. It mimics the interactions of cells within the heart on a small chip and is part of the larger organ-on-a-chip (OoC) suite. The actual design of […]
February 7, 2024
Via: Industry TodayABB Robotics and METTLER TOLEDO, a global supplier of precision instruments and services, have signed a Memorandum of Understanding (MOU) to offer an innovative solution that seamlessly integrates ABB’s robots with LabX, METTLER TOLEDO’s laboratory instrument management software. The combined […]
January 31, 2024
Via: MedTech DiveThe medical device industry is set up for an eventful year after weathering numerous challenges for the past four years due to the COVID-19 pandemic and other macroeconomic factors. Last year, device companies found some stability as those pressures eased, […]
November 17, 2023
Via: MedTech DiveSection 506J of the Federal Food, Drug, and Cosmetic Act requires manufacturers of certain devices to tell the FDA in advance if they are permanently ending production of the product or face an interruption that is likely to meaningfully impact […]
November 10, 2023
Via: MedTech DiveAcutus developed mapping technology to try to reduce the rate of atrial fibrillation recurrence after patients undergo ablation. The company pitched its non-contact approach to mapping as a better fit for atrial fibrillation and other complex or unstable arrhythmias, but […]
November 2, 2023
Via: MedTech DiveThe guidance, first issued in May 2020, was supposed to expire at the end of the public health emergency. The policy allowed for any required production process changes, like social distancing, or manufacturing changes due to supply chain shortages, which […]
October 10, 2023
Via: Business Facilities MagazineInnovation drives growth in the biotech and pharmaceutical space. According to The Pharmaceutical Research and Manufacturers of America (PhRMA), the U.S. biopharmaceutical sector directly supports more than 900,000 jobs across the economy. Manufacturing employs more than 330,000 high-wage workers in […]
September 1, 2023
Via: MedTech DiveBeta Bionics raised a $57 million series C financing round early last year. That financing, which was co-led by a syndicate of venture capital funds with an assist from strategic partner Novo Nordisk, equipped the company to develop iLet, file […]
August 9, 2023
Via: MedTech DiveMusk has made big claims since founding Neuralink in 2016, pitching its technology as both a treatment of conditions such as blindness, and a way to augment humans to compete against artificial intelligence. To start testing if those claims hold […]
Energy, Industry Focus Areas, Medical
July 27, 2023
Via: Industry TodayTeva Pharmaceutical Industries Ltd., a leading generic pharmaceutical company, (NYSE and TASE: TEVA) announced today that it is working with Honeywell (NASDAQ: HON) to help reduce energy consumption and carbon emissions at its Debrecen, Hungary, manufacturing facility. Teva will leverage […]
July 20, 2023
Via: MedTech DiveJohnson & Johnson raised its full-year earnings forecast for the second quarter in a row, reflecting improved procedure volumes and a steady drumbeat of new product launches in its medtech segment. The New Brunswick, New Jersey-based company now expects revenue […]
Design & Planning, Industry Focus Areas, Medical, Process
July 17, 2023
Via: Manufacturing TomorrowIn a groundbreaking move to revolutionize the field of biomedical research, Alfa Chemistry recently announced the launch of its highly anticipated custom design and manufacturing services for organs-on-chips. This cutting-edge technology provides scientists and researchers with an innovative platform to […]
June 15, 2023
Via: Business Facilities MagazineEnzene Biosciences, Ltd., a global biotech company based in Pune, India, will invest $50 million to open a state-of-the-art biopharmaceutical manufacturing plant in New Jersey. Operations in the new facility, located on the Princeton West Innovation Campus in Hopewell, are […]
Industry Focus Areas, Medical, Regulations
June 1, 2023
Via: MedTech DiveFDA inspectors concluded their assessment of iRhythm’s facility in Cypress, Calif. in August 2022. The FDA visit led to a Form 483 later that month. iRhythm took steps to address the concerns raised in the 483 but its actions failed […]
May 24, 2023
Via: MedTech DiveIntegra initiated the voluntary recall after an internal investigation found endotoxin testing deviations. The deviations may have resulted in the release of medical devices with levels of endotoxins that exceed the levels permitted by the product specifications, the company said. […]
May 2, 2023
Via: MedTech DiveIn the multibillion-dollar market for diabetes technology, Medtronic’s U.S. diabetes sales have declined in the last four years as the company grappled with regulators and competitors rolled out new devices. With two strokes of a pen in late April, the […]
Industry Focus Areas, Medical, News
April 26, 2023
Via: MedTech DiveBoston Scientific reported first-quarter sales that exceeded the company’s forecast, saying it gained market share across its businesses as demand for procedures using its medical devices rebounded from a year ago. The company raised its full-year sales and profit forecasts, […]
April 11, 2023
Via: MedTech DiveMedical device trade groups raised concerns about the capacity to sterilize medical devices in response to proposed ethylene oxide regulations by the Environmental Protection Agency. The EPA seeks to reduce emissions of the gas, which it says can cause cancer […]
Industry Focus Areas, Medical, News
March 13, 2023
Via: The Wall Street JournalPfizer Inc. has agreed to pay $43 billion for biotech Seagen Inc. SGEN 16.29%increase; green up pointing triangle and its pioneering class of targeted cancer drugs. Under the terms, Pfizer would pay $229 a share in cash, the drugmaker said […]