Medtronic Archives - Page 19 of 59 - Medical Design Sourcing

What does the future hold for AI in medical devices?

(Image courtesy of the FDA)

Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world.

Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control plan (PCCP) to help build a regulatory structure for such technology.

These topics and more spurred intriguing commentary on a panel at AdvaMed’s MedTech Conference in Boston today.

The panel featured viewpoints across all angles of the space. Dr. Yuri Maricich, CMO and head of development at Pear Therapeutics, offered thoughts from the developer of digital therapeutics. Brendan O’Leary, acting director of the Digital Health Center of Excellence at the FDA, provided the regulatory vantage po…

Medtronic plans spinoff of patient monitoring, respiratory intervention businesses

Medtronic (NYSE: MDT) today announced its intention to pursue a separation of the company’s Patient Monitoring and Respiratory Interventions businesses, part of the company’s Medical Surgical portfolio.

The separation is the next step in the Fridley, Minnesota-based company’s ongoing portfolio assessment. It will allow the company to better focus investments.

“We are executing on our portfolio management strategy, taking action to create value for Medtronic and our shareholders,” CEO Geoff Martha said in a news release.

Martha later added: “Looking ahead, we remain focused on active portfolio management with an ongoing process of evaluating potential additions and subtractions to further accelerate Medtronic’s growth over the long-term.”

The patient monitoring product portfolio getting spun off will include Nellcor pulse oximetry, Microstream capnography, BIS brain monitoring, Invos perfusion monitor…

Medtronic unveils new neurovascular innovation incubator program

Dan Volz (right) and Derek Crittenden (left) present the Medtronic Co-Lab program at DeviceTalks West in Santa Clara, California.

Medtronic (NYSE:MDT) revealed its plans for an incubation and acceleration platform for innovation in the neurovascular space.

In a presentation yesterday at DeviceTalks West in Santa Clara, California, the company unveiled its plan to bring innovations to market to address strokes. Daniel Volz, president of Medtronic Neurovascular, and Derek Crittenden, Medtronic’s new technology & strategy program manager, presented the news.

“We’re pleased to share with you today the Medtronic neurovascular Co-Lab platform,” Volz said. “This is a community platform designed to transform ideas and technologies into novel global therapies by providing physicians and entrepreneurs with insight with support, and most importantly, making sure innovation has the chance to touch as many people around the world as possibl…

Medtronic expands global access to robotic-assisted surgery with three new global indication expansions

Medtronic’s Hugo robot-assisted surgery system [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today announced it received three significant global market entrance and indication expansion approvals for its Hugo robotic-assisted surgery system.

The Fridley, Minnesota-based company won CE mark clearance for general surgery indication, Health Canada license for general laparoscopic surgery indication and Ministry of Health, Labor and Welfare approval for urologic surgical and gynecological laparoscopic indications in Japan.

The new indications and approvals enable access to robotic-assisted surgery in Europe, North America and Asia to extend the benefits of minimally invasive surgery.

Robotic-assisted procedures have fewer complications, shorter hospital stays and faster return to normal activities. General surgery, gynecology and urology account for more than 80% of all robotic-assisted surgical procedures performed globally and general surgery is the fast…

FDA approves expanded label for heart pacing from Medtronic

The HIS Bundle. [Image from Medtronic]Medtronic (NYSE:MDT) announced that it received expanded FDA approval for a cardiac lead that taps into the heart’s natural electrical system.

This process is commonly referred to as “conduction system pacing,” according to Medtronic. It gives patients needed therapy while avoiding complications sometimes associated with traditional pacing methods, like cardiomyopathy.

Fridley, Minnesota-based Medtronic said this helps to ensure that pacing closely mimics the heart’s physiologic contractions. It allows the heart’s ventricles to work in coordination. The SelectSure MRI SureScan Model 3830 first received FDA approval in 2018 for HIS-Bundle pacing.

The cardiac lead’s expanded approval covers pacing and sensing at the HIS-Bundle or in the left bundle branch area. It represents an alternative to apical pacing in the right ventricle in a single- or dual-chamber pac…

Medtronic launches diabetes insights program for MiniMed users

The MiniMed 770G system. [Image from Medtronic]Medtronic (NYSE:MDT) announced today that it introduced a new diabetes management program for users of the MiniMed 770G insulin pump.

The medtech giant calls the new program My Insights. It designed it exclusively for individuals using the MiniMed 770G hybrid closed-loop insulin delivery system.

Get the full story at our sister site, Drug Delivery Business News.

Medtronic to install 115 GI Genius modules across VA facilities

Medtronic’s GI Genius intelligent endoscopy module. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that its Gastrointestinal Business received a contract to install GI Genius systems at some Veterans Affairs (VA) facilities.

The contract comes through a partnership with a Service-Disabled Veteran-Owned Small Businesses (SDVOSB). Medtronic will install 115 GI Genius intelligent endoscopy modules across numerous VA medical facilities in the U.S.

Veterans can now access Medtronic’s artificial intelligence (AI) technology. The company designed it to improve the accuracy of polyp detection in colonoscopy screening. According to a news release, the Veteran’s Health Administration performs approximately 250,000 colonoscopies each year.

“We’re proud to give back to the men and women who have served our country by extending this powerful and proven tool in the fight against colorectal cancer,” said Geof…

FDA clears Nexpowder endoscopic hemostasis system from Medtronic

The Nexpowder system. [Image from Medtronic]Medtronic (NYSE:MDT) announced that it received FDA clearance for its Nexpowder endoscopic hemostasis system.

Nexpowder uses a noncontact, nonthermal and nontraumatic hemostatic powder. The powder sprays through a catheter that features a proprietary powder-coating technology for minimized clogging.

The Nexpowder design provides improved visibility and control in the treatment of upper gastrointestinal (GI) nonvariceal bleeding. According to a news release, upper GI bleeding accounts for 75% of all acute GI bleeding cases.

“We are very excited to bring the innovative, Nexpowder system to gastroenterologists. We considered the potential impact on physicians and patients alike, by meeting a clear need to reduce mortality from upper GI bleeding, a condition that causes death for one out of every 1,000 people while also reducing rebleeding, which happens in 20% of all upper GI bleeding cases,” said Gio Di Napoli, pres…

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The tide has turned.

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FDA approves Medtronic drug-eluting stents for treating bifurcation lesions

The Resolute Onyx drug-eluting stent. [Image from Medtronic]Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions.

Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions (PCIs). It applies to the FDA-approved and CE-marked Onyx Frontier and Resolute Onyx drug-eluting stents.

Get the full story at our sister site, Drug Delivery Business News.

Medtronic, FDA warn on potential cybersecurity risk with MiniMed insulin pump

[Image from Medtronic]Medtronic (NYSE:MDT) issued an urgent medical device correction notice to warn of potential issues with its MiniMed automated insulin delivery system.

The notice — dated this month — covers the company’s MiniMed 600 series insulin pumps (MiniMed 630G and 670G). Affected devices also include the Guardian Link 3 transmitter, Contour Next Link 2.4 blood glucose monitor and the CareLink USB.

Medtronic recently identified a potential issue through internal testing with the devices. Under specific circumstances, unauthorized access could compromise communication between the pump system’s components.

Get the full story at our sister site, Drug Delivery Business News.

Getinge partners with Medtronic to make Radiant balloon-expandable covered stent

The Radiant balloon-expandable covered stent created by Medtronic and Getinge [Image from Medtronic]Getinge announced today announced a partnership with Medtronic (NYSE:MDT) over the Radiant balloon-expandable stent, which received CE mark.

Radiant is designed for use in chimney endovascular aneurysm repair (ChEVAR) with the Endurant II/IIs stent graft system. It maintains perfusion to renal arteries when used in combination with the stent graft.

The medtech giant said that Radiant is the first and only covered stent indicated for such use. It comes from a long-term collaboration between Medtronic and Getinge. The platform leverages Getinge’s Advanta V12 balloon expandable covered stent design.

Get the full story at our sister site, Medical Tubing & Extrusion.