Medtech development is hard. Medical device creation can require manufacturing know-how in areas as wide-ranging as electrical components, high-performance polymers, molding and machining – and that doesn’t even include the required expertise in design, regulatory requirements and achieving reimbursement. The good news is that the companies serving the medical device industry have become specialized experts. […]
Dems seek to force EPA action on ethylene oxide monitoring
Democrats in both houses of Congress have introduced legislation that would force the U.S. Environmental Protection Agency to better monitor emissions of ethylene oxide (EtO) from plants that manufacture the toxic gas or use it to sterilize medical devices. The Public Health Air Quality Act of 2020, sponsored by Sen. Tammy Duckworth (Ill.) and Rep. Lisa Blunt Rochester […]
B,. Braun, Baxter, CareStream, Green Hills affected by Ripple20 cyber vulnerabilities
The U.S. Cybersecurity and Infrastructure Security Agency (CISA) said it is aware of vulnerabilities affecting Treck IP stack implications for embedded systems. Known as Ripple20, the vulnerabilities allow a remote attacker to exploit and take control of an affected system, according to the CISA statement. Among the affected companies were B. Braun, Baxter (NYSE:BAX), Green Hills […]
Medtech manufacturers must add warning label to drug-eluting PAD devices
UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]
B. Braun’s top North American executive to retire
B. Braun announced today that Caroll H. Neubauer will retire at the end of August after 24 years leading the Melsungen, Germany–based medical and drug delivery device giant’s North America operations. Jean-Claude Dubacher, a former Johnson & Johnson and Abbott executive who already took over Neubauer’s role as CEO of B. Braun Medical at the […]
Next COVID-19 device shortage? ‘Smart’ infusion pumps
Severely ill COVID-19 patients may need multiple medications delivered by infusion pumps. Manufacturers and hospitals are planning on how to avoid shortages of these pumps and the associated tubing. You’ve likely seen the videos of ICU hallways lined with medical devices that would normally be in patient rooms. Among them are machines that are ubiquitous […]
B. Braun lands FDA EUA for use of infusion pumps with nebulizers to treat COVID-19
B. Braun Medical announced that it received FDA emergency use authorization to use its infusion pumps with nebulizers to treat patients with COVID-19. The Bethlehem, Pa.-based company’s authorization win includes its Perfusor space syringe infusion pump, Infusomat space volumetric infusion pump and Outlook ES pump systems. Health providers can use the pumps for tracheal delivery […]
B. Braun sued in Pa. over ethylene oxide exposure
A Pennsylvania man has filed a lawsuit against B. Braun Medical over emissions of the sterilant gas ethylene oxide (EtO). The man, Adam Akarsoy, lives and works near a B. Braun sterilization plant in Hanover, Pa., and filed the federal lawsuit seeking certification as a class action. Akarsoy claims that B. Braun “has consistently emitted, on average, nearly […]
B. Braun Medical names new chairman & CEO
B. Braun Medical has announced that Jean-Claude Dubacher will succeed longtime company leader Carroll Neubauer as chairman and CEO on Jan. 1, 2020. Neubauer will stay on as chairman and CEO of B. Braun of America, which owns B. Braun Medical (Bethlehem, Pa.), admixture pharmaceutical firm CAPS, Aesculap and B.Braun Interventional Systems. He has been […]
Stent makers point to quality-of-life findings by massive federal study
The giant federal study that found the use of stents in stable heart-disease patients is no better than drugs to treat clogged arteries reached another, less-hyped conclusion. Manufacturers of stents for percutaneous coronary intervention (PCI) note that the Ischemia study also concluded that patients who undergo a stenting procedure have a better quality of life. They suffer […]
Study: Stents no better than drugs for stable heart disease
This article has been updated with stock market results and comments from Medtronic. A major new study has concluded that the use of stents in stable heart disease patients is no better than drugs to treat clogged arteries. Results of the Ischemia study were released at the American Heart Association annual meeting in Philadelphia on Saturday. The […]
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