What’s next for Medtronic’s RDN program after FDA approval?
MassDevice | Outsourcing
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4M ago
Medtronic is planning its first commercial renal denervation (RDN) cases and is already running a postmarket study after winning FDA approval of its Symplicity Spyral system for hypertension. In an interview before the Thanksgiving break, Medtronic SVP Jason Weidman — who’s also president of the company’s coronary and RDN business — said he expects the ..read more
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‘Catastrophic explosion’ and resin shortage led Medtronic’s supply chain problems
MassDevice | Outsourcing
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2y ago
Medtronic CEO Geoff Martha today said a “catastrophic explosion” in Medtronic’s supply chain for packaging and a shortage of resins were the biggest issues hurting the company’s fourth-quarter performance. Fridley, Minnesota-based Medtronic (NYSE:MDT) reported about $350 million less in sales than analysts were expecting for the quarter, which ended April 29. Martha said about 75% of ..read more
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The cloud is transforming medtech: Amazon, Microsoft, Google, J&J, Philips and GE Healthcare leaders explain
MassDevice | Outsourcing
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2y ago
Leaders in medtech and cloud computing discuss payoffs and potential in device connectivity, product development and cross-industry partnerships. If knowledge is power, that power comes from a steady stream of information, and we know there’s no shortage of that in healthcare. The challenge has long been how to capture that information, store it, analyze it ..read more
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TE Connectivity beats the Street with Q2 results
MassDevice | Outsourcing
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2y ago
TE Connectivity (NYSE:TEL) posted second-quarter results today that beat the consensus forecast on Wall Street. The Schaffhausen, Switzerland–based company provides connectivity and sensor solutions for a broad range of industries, including medtech. TE Connectivity reported profits of $560 million, or $1.71 per diluted share, on sales of $4.0 billion for the three months ended March ..read more
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Manufacturing matchmaker Fictiv raises $100M for supply chain push
MassDevice | Outsourcing
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2y ago
Fictiv has closed a $100 million Series E funding round, the on-demand manufacturing technology company said today. Fictiv focuses on “helping companies produce better products,” co-founder and CEO Dave Evans said, with three main offerings: new product development, engineer-to-order products, and maintenance, repair and operations (MRO). But the company doesn’t actually own any manufacturing equipment ..read more
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Moody’s warns of cybersecurity, antitrust and supplier risks for medical device companies
MassDevice | Outsourcing
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2y ago
Medical device companies face heightened cybersecurity burdens, antitrust enforcement and supplier risks, according to a new report out of Moody’s. The research firm’s previous quarterly report in February called attention to continued supply chain and labor problems for medtech. The report flagged legislative proposals for new rules and regulations on medical device developers and manufacturers, including new ..read more
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Intuitive eyes sole-source suppliers as it expands capacity
MassDevice | Outsourcing
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2y ago
Top executives at Intuitive Surgical (Nasdaq: ISRG) have sole-source suppliers on their minds as they ramp up manufacturing capacity in the face of continued supply chain challenges. The robotic surgery technology developer’s growth and mindfulness of supply chain resiliency could bring new opportunities for Intuitive’s suppliers — along with competition from others who want in ..read more
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Sterifre Medical prepares to launch its Aura desktop disinfection device
MassDevice | Outsourcing
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2y ago
Sterifre Medical is demonstrating its Aura device and courting investors as it prepares to launch the automatic point-of-care disinfection system. The Aura is a portable machine that circulates hydrogen peroxide and activated oxygen with the push of a single button to disinfect stethoscopes, sensors, pumps, tablets, phones, keys, badges and anything else you can fit ..read more
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How Minnetronix helped Oculogica launch its new EyeBOX concussion diagnostic device
MassDevice | Outsourcing
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2y ago
Less than three months after Oculogica won FDA clearance for its portable concussion diagnostic device, contract manufacturer Minnetronix is about to ship the first units to customers. “We are aspiring to be a vital sign for brain health,” Oculogica CEO Rosina Samadani said in an interview. Diagnosing a concussion used to require asking a patient ..read more
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How Phillips-Medisize helped Sotech Health develop a breath analyzer for COVID-19
MassDevice | Outsourcing
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2y ago
Medtech contract manufacturing giant Phillips-Medisize used its human-factors product design expertise to help startup Sotech Health create what the companies claim is a breath sensor system that can detect COVID-19 in less than 30 seconds. Dallas-based Sotech Health has submitted the device to the FDA for an emergency use authorization. It’s also seeking regulatory nods in Canada ..read more
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