MassDevice Archives - Page 222 of 587 - Medical Design Sourcing

Integra’s CereLink ICP Monitor recall is Class I

[Image from Integra]The FDA has labeled the recall of the Integra LifeSciences (Nasdaq:IART) CereLink system as Class I, the most serious kind.

Integra designed its CereLink system for intracranial pressure (ICP) monitoring. Last week, the company announced an immediate, voluntary global product removal of the systems.

An FDA notice classified the U.S. recall, initiated by Integra on June 22, 2022, as the most serious kind yesterday. Integra recalled a total of 388 devices (product codes 826820 and 826820P) in the U.S. The company distributed affected devices between June 1, 2021, and May 31, 2022.

Integra reported 105 global complaints associated with the recall as of July 31, 2022. As of Aug. 24, the FDA received at least 68 reports associated with the issue. Reports include one patient injury and one patient death. The report of death described a malfunctioning CereLink monitor during use in a critically injured patient. Replacing the ICP sensor mitigate…

FDA clears eCential Robotics’ spine surgery robot

The robotic arm of the eCential Robotics platform for spine surgery [Image courtesy of eCential Robotics]French robotic spine surgery tech company eCential Robotics announced today that it has received FDA clearance for its 3D imaging, navigation and robotics guidance system.

With the help of recent partnerships with U.S. implant companies, Gières, France–based eCential Robotics plans to start selling its surgical robotics system in North America. The company has already sold 10 systems in Europe, with more than 2,000 surgeries.

“The FDA clearance of the eCential Robotics unified platform recognizes reliability and robustness of our product, confirms the confidence in eCential Robotics’ unique concept of focusing surgical workflows on the essential via a unified, open and multi-app system, and also encourages our ambition to expand our footprint in the United States,” said Laurence Chabanas, the company’s chief strategy officer and U.S. CEO…

Zimmer Biomet, Surgical Planning partner on total hip replacement

[Image from Surgical Planning]Zimmer Biomet (NYSE:ZBH) announced today that it signed an exclusive, multi-year co-marketing agreement with Surgical Planning.

Warsaw, Indiana-based Zimmer Biomet’s agreement with Surgical planning centers around the commercialization of Surgical Planning’s HipInsight.

HipInsight is the first FDA-cleared, mixed-reality navigation system for total hip replacement. It is customized for Zimmer Biomet’s hip implant portfolio, according to a news release. It allows surgeons to use Microsoft HoloLens 2 glasses to visualize a hologram of the patient’s pelvic anatomy during surgery.

Zimmer Biomet said that HipInsight expands the capabilities of its ZBEdge suite of integrated smart, digital and robotic technologies. The company added HipInsight to its OptiVu mixed reality portfolio of applications.

“The addition of HipInsight to our mixed reality portfolio advances our commitment to transform the su…

Dexcom names Jake Leach chief operating officer

Dexcom COO Jake Leach

Dexcom (Nasdaq:DXCM) announced that it promoted chief technology officer Jake Leach to the chief operating officer (COO) role.

Leach served as CTO since 2018, leading the company’s research, product development, product management and engineering departments. He joined the company in 2004 to lead the development of sensor electronics for its first commercial continuous glucose monitor (CGM) system.

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

EndoQuest Robotics to install surgical robot system at Brigham and Women’s Hospital

[Image from EndoQuest’s website]EndoQuest Robotics announced today that its proprietary surgical robot system will be installed at a major Boston hospital.

Houston-based EndoQuest’s endoluminal surgical (ELS) system will be installed at Brigham and Women’s Hospital (BWH) in Boston.

It’s the world’s first endoluminal surgical robotic system for scar-free upper and lower gastrointestinal surgery, according to a news release. The platform makes it possible for therapeutic endoscopists and surgeons to operate through a trans-oral or trans-anal approach.

EndoQuest is among MassDevice’s 16 surgical robotics companies you need to know. READ HERE

EndoQuest describes its system as an innovative advance in minimally invasive surgery. It designed the ELS system to combine the flexibility of conventional endoscopy with the advantages of traditional surgical techniques.

“Successful endol…

Masimo launches health-tracking watch for consumers

[Image from Masimo]Masimo (Nasdaq:MASI) announced today that it began the full market release of its Masimo W1 health watch for consumer use.

Irvine, California-based Masimo designed its W1 watch to offer accurate, continuous measurements and insightful health data. The wrist-worn wearable builds on the company’s personal, lifestyle-friendly designs for non-invasive blood parameter monitoring solutions.

For the first time in a watch format, the company said, W1 provides accurate, continuous monitoring of oxygen saturation (SpO2). It also provides pulse rate, respiration rate and more measurements. In a limited market release, the Masimo W1 offers hydration index measurements.

The device takes 86,400 measurements a day for second-by-second data trending. It pairs through secure Bluetooth to the Masimo Health smartphone app.

Masimo launched the Personal SafetyNet alongside the watch. Personal SafetyNet, a paid subscription service within the comp…

FDA clears syringe infusion pump with Dose IQ software from Baxter

[Image from Baxter website]Baxter (NYSE:BAX) announced today that the FDA issued 510(k) clearance to its Novum IQ infusion pump with Dose IQ safety software.

Deerfield, Illinois-based Baxter designed its new Novum IQ syringe infusion pump (SYR) to deliver small amounts of fluid at low rates. It includes a technologically integrated user experience with enhanced safety features. The system offers advanced connectivity, configurable anesthesia care settings and a set portfolio for optimum accuracy.

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

Medtronic, BioIntelliSense partner on distribution of wearable patient monitoring device

The BioButton from BioIntelliSense

Medtronic (NYSE:MDT) announced today that it partnered with BioIntelliSense on distribution rights for the BioButton device.

BioButton, a multi-paremter wearable for continuous, connected monitoring, measures up to 1,440 vital sign measurements per day. Its measurements include skin temperature, respiratory rate at rest, and heart rate at rest.

The device, combined with advanced analytics, helps clinicians to better detect early signs of patient deterioration. Conversely, it can help to identify stable patients who may be candidates for earlier hospital discharge.

BioIntelliSense’s rechargeable device also offers configurable acute and post-acute modes, according to a news release. These modes help to continuously monitor patients transitioning from higher to lower acuity settings.

The partnership enables the Medtronic patient monitoring business to offer access to a medical grade device that provides conti…

JenaValve raises $100M Series C for TAVR tech

JenaValve Technology announced today that it completed the initial closing of a $100 million Series C financing round.

Irvine, California-based JenaValve develops and manufactures differentiated transcatheter aortic valve replacement (TAVR) systems.

The company intends to use proceeds from the financing to complete its FDA investigational device exemption (IDE) premarket approval (PMA) study to garner FDA approval for the Trilogy heart valve system. JenaValve designed Trilogy for high surgical risk patients with symptomatic, severe aortic regurgitation (AR).

Additionally, the company plans to use the proceeds to bolster its real-world data development initiatives in Europe. JenaValve also plans to expand its worldwide manufacturing capabilities.

“JenaValve is committed to becoming the first and only FDA-approved transfemoral transcatheter valve system indicated for symptomatic, severe aortic regurgitation, addressing an estimated multi-billion-dol…

Inari Medical launches trial to assess ClotTriever system in deep vein thrombosis

Inari Medical (Nasdaq:NARI) announced that it will conduct a trial for its ClotTriever system for iliofemoral deep vein thrombosis (DVT).

The Irvine, California-based company’s Defiance trial will compare ClotTriever to anticoagulation only for patients with iliofemoral DVT.

Defiance will enroll 300 patients across up to 60 centers around the world. It represents Inari’s second randomized controlled trial, running in parallel to the Peerless trial. Peerless compares the FlowTriever to catheter-directed thrombolytics in pulmonary embolism.

According to an Inari news release, the primary endpoint is a hierarchical composite of treatment failure and PTS severity at 6 months.

Dr. Xhorlina Marko, co-principal investigator and interventional radiologist at Beaumont Health, said in the release that Defiance is the first randomized controlled trial that compares mechanical thrombectomy to anticoagulation for the treatment of DVT.

Dr. St…

Philips to pay $4.2M in DOJ settlement over patient monitoring device modifications

[Image from Philips’ website]Philips (NYSE:PHG) today agreed to pay approximately $4.2 million to resolve allegations of substituting key components of a monitoring device.

The company settled with the U.S. Department of Justice (DOJ) over claims that it substituted the components of its Intellivue MP2 mobile patient monitoring device that it sold to military purchasers without rectifying the device for military airworthiness.

A Philips spokesperson said that, among the company’s discussions with DOJ, it reached the final stages of settlement discussions regarding three separate matters, all of which are related to its connected care portfolio. This is the first of the three settlements to have been announced.

Despite their relation to the connected care portfolio, none of the three settlement discussions are related to the June 2021 Philips Respironics recall, for which the company is also in talks with DOJ.

Acc…

Hamilton Medical’s ventilator recall is Class I

The FDA issued a notice labeling a recall of the Hamilton Medical Hamilton-C6 intensive care ventilator as Class I, the most serious kind.

Hamilton Medical initiated the recall for its ventilator on June 27, 2022. The recall is due to a hardware issue with the ventilator’s status indicator board. It covers 497 devices distributed between Aug. 31, 2017, and May 20, 2022. To date, Hamilton received 128 complaints related to the issue, with no deaths or injuries reported.

According to the FDA notice, customer complaints revealed that the Hamilton-C6 ventilator’s status indicator board may become loose, allowing liquid to enter (ingress) between the indicator board and the ventilator’s main board.

Water ingress may cause the ventilator to have a technical fault. This would revert the device to a safety ventilation mode or revert to an ambient state. In such a state, the patient breathes ambient room air with no assistance or support from the machine. Read more