MassDevice Archives - Page 7 of 587 - Medical Design Sourcing

Medtronic highlights global performance of MiniMed 780G automated insulin delivery system

The MiniMed 780G with the Guardian 4 sensor. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + shared new clinical and real-world evidence backing the use of its MiniMed 780G system around the world.

Data shared at ATTD 2024 in Florence, Italy, included the largest set of data from early users in the U.S. Results built upon three-year data from more than 100,000 real-world users who outperformed international time in range targets.

Medtronic’s MiniMed 780G, its latest-generation automated insulin delivery system, won FDA approval in April 2023. The current iteration uses the latest Guardian 4 technology and requires no fingersticks while in “SmartGuard” mode. It provides meal detection technology providing automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs.

MiniMed 780G with Guardian 4 offers insul…

FDA accepts Onward BCI into advisory program

The Onward ARC-IM neurostimulation device. [Image courtesy of Onward]Onward Medical announced today that the FDA accepted it into its new Total Product Lifecycle Advisory Program (TAP) — a move that could boost the development of Onward’s BCI technology.

Acceptance into the TAP program comes on the heels of FDA breakthrough device designation for the ARC-BCI system last month. Breakthrough device designation is a requirement for TAP consideration, according to a news release. Onward says that this nod made its BCI only the second such system accepted into the program.

TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Onward can benefit from more timely premarket interactions, earlier identification and mitigation of device development risk and a more efficient premarket review for its ARC-BCI system.

ARC-BCI uses brain-computer i…

FDA clears pulsed field ablation electrode tech from Pulse Biosciences

The CellFX nsPFA percutaneous electrode system. [Image courtesy of Pulse Biosciences]Pulse Biosciences (Nasdaq:PLSE) announced that the FDA granted 510(k) clearance for its CellFX nsPFA percutaneous electrode system.

The Hayward, California-based company develops the CellFX nanosecond pulsed field ablation (nsPFA) system. Its percutaneous electrode system enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures.

CellFX nsPFA’s percutaneous electrode system features a percutaneous needle electrode for use with the proprietary CellFX console. The company designed the novel electrode to harness and deliver the key advantages of nsPFA energy. It enables the precise, nonthermal removal of cellular tissue without damaging noncellular structures or inducing thermal necrosis.

Pulse Biosciences designed this percutaneous electrode for non-cardiac applications, unlike other PFA technology on the market. The likes of Medtronic a…

iRhythm closes offering worth more than $660M

iRhythm (Nasdaq: IRTC) + announced today that it closed an offering of senior notes worth gross proceeds of $661.25 million.

The San Francisco-based cardiac monitor maker said earlier this week that it intends to offer $450 million in convertible senior notes. Approximately 17 hours later, it upsized that offering to a base of $575 million.

San Francisco–based iRhythm sold the notes — due 2029 — to qualified institutional buyers. Proceeds include the full exercise of an option to buy up to an additional $86.25 million in notes. The notes will be senior, unsecured obligations of iRhythm, with interest payable semi-annually in arrears. They notes mature on Sept. 1, 2029, unless earlier converted, repurchased or redeemed.

Holders can require iRhythm to repurchase for cash all or a portion of the notes at 100% of their principal amount, plus interest.

The company estimates net proceeds of approxi…

FDA clears Getinge’s cardiovascular surgery offering, company lanches new table, light in U.S.

The Maquet Corin OR table. [Image courtesy of Getinge]Getinge this week announced a major FDA clearance and the beginning of a U.S. launch of multiple surgical tools.

The Gothenburg, Sweden-based company won 510(k) clearance for its Vasoview Hemopro 3. This adds to the company’s portfolio of endoscopic vessel harvesting (EVH) solutions.

Getinge said it designed the system with customer centricity top-of-mind. It hopes to offer enhanced procedural efficiency with the upcoming launch of this product, according to a news release. The company anticipates a U.S. launch in the third quarter of 2024. Submissions for approval in other key markets remains in progress.

Advanced features include enhanced smoke evacuation, regulated energy control, ergonomic game controller-style handle and an integrated cable.

“EVH is a therapy significantly helping patients towards faster recovery by minimizing surgical trauma and reducing post-operative pain. By o…

Innovation Zed, Enhance-D collab on insulin dosing management

The InsulCheck DOSE device with the Enhance-D platform. [Image courtesy of Innovation Zed]Innovation Zed announced this week that it entered into a strategic partnership with Enhance-D to optimize diabetes therapy.

Switzerland-based Enhance-D develops a digital health platform for enhancing diabetes and exercise management. It designed its platform to empower people with diabetes through cutting-edge technologies and personalized solutions.

Ireland-based Innovation Zed develops insulin dosing technology, including the InsulCheck DOSE add-on device for pen injectors. The company featured on our 2023 list of drug delivery innovations you should know.

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

Lumicell earns positive FDA panel decision on surgical imaging tool, approval decision expected soon

The Lumicell direct visualization system (DVS). [Image courtesy of Lumicell]Lumicell announced that an FDA advisory committee voted in support of the benefit-risk profile of its LumiSight offering.

LumiSight, an optical imaging agent, works in combination with the Lumicell direct visualization system (DVS) in breast cancer imaging. The combination product — a fluorescence-guided surgical imaging tool — detects residual cancer in real-time during a lumpectomy.

Lumicell’s system enables real-time assessments of the breast cavity to remove residual cancer tissue. Such tissue would otherwise have been missed, according to Dr. Shelly Hwang. In a news release, Hwang, leader of Duke University’s Breast Oncology Program, said it’s “unlike any other surgical tool available” today.

The FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) voted 16-2 in favor of LumiSight. One voter abstained.

MIDAC’s decision came on …

Know Labs has positive accuracy data for non-invasive glucose monitor

A rendering of the KnowU non-invasive glucose monitor. [Image courtesy of Know Labs]Know Labs (NYSE:KNW) announced interim results highlighting the accuracy of its non-invasive glucose monitoring sensor.

Seattle-based Know Labs conducted a study evaluating its proprietary radiofrequency (RF) dielectric sensor. The sensor non-invasively measured blood glucose in participants with prediabetes and type 2 diabetes. It used venous blood as a comparative reference.

Know Labs reported a mean absolute relative difference (MARD) — a measure of accuracy — of 11.1%. Comparatively, market-leading minimally invasive CGMs from Dexcom and Abbott have demonstrated higher levels of accuracy. Dexcom’s G7 previously demonstrated a MARD of 8.2%, while Abbott’s FreeStyle Libre 3 came in at 7.6%.

However, Know Labs’ non-invasive offering remains an interesting prospect, given there are no FDA-cleared CGMs of this kind at present. Larry Ellingson, a Know Labs board member, …

Myomo has a strong outlook for 2024 with new Medicare coverage

Myomo (NYSE:MYO) shares took a hit today on fourth-quarter results that came up short of the consensus forecast.

Shares of MYO fell 10% to $3.16 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — ticked up 0.5%.

The Boston-based wearable exoskeleton maker posted losses of $2.5 million in the quarter. That amounts to 7¢ per share on sales of $4.76 million for the three months ended Dec. 31, 2023. Myomo’s bottom line dipped 13.5% deeper into the red on sales growth of 17.7%.

Losses per share fell 1¢ shy of Wall Street expectations, while sales came up just short of the projected $4.79 million.

“Fourth quarter and full year 2023 revenues were in line with our expectations as we continued to post solid gains in all key performance metrics,” said Paul R. Gudonis, Myomo chair and CEO. “Our pace in converting pipeline to backlog accele…

Insulet shares data demonstrating Omnipod 5’s superiority to pump therapy

The Omnipod 5 with the Abbott FreeStyle Libre 2 Plus. [Image courtesy of Insulet]Insulet (Nasdaq: PODD) + today announced positive results from a clinical trial pitting its Omnipod 5 against non-automated insulin therapy.

Acton, Massachusetts-based Insulet conducted its first randomized controlled trial showing improved glycemic and patient-reported outcomes in type 1 diabetes with the Omnipod 5 automated insulin delivery (AID) system. The company presented results at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Florence, Italy.

Dr. Eric Renard of Montpellier University Hospital presented the data. It highlighted Omnipod 5’s efficacy and safety compared to insulin pump therapy with CGM in adults with type 1 diabetes in the U.S. and France. The study marked the first Omnipod 5 randomized controlled trial to date. It’s also the first time the system has been evaluated by internati…

Karl Storz launches surgical education tech for Apple Vision Pro

With the CollaboratOR 3D app for Apple Vision Pro, surgical staff can immerse themselves in 3D content from surgical procedures without entering the OR. [Image courtesy of Karl Storz]Karl Storz announced that it released the CollaboratOR 3D app for Apple Vision Pro to provide immersive surgical education.

This marks yet another medtech application on Apple’s VR headset, with Siemens Healthineers and Stryker recently unveiling similar offerings.

Karl Storz designed its application in tandem with software developer T1V to complement the functionality of OR1, an integrated operating room solution. The company said it identified a need to improve the educational experience and collaboration opportunities for surgeons. This includes new surgical residents and practicing surgeons across a wide range of specialties.

CollaboratOR 3D allows surgical staff to immerse themselves in 3D content from surgical procedures without entering the OR. It can both enhance …

Medtronic launches intelligent data collection tech for spine surgery

Medtronic (NYSE: MDT) + announced that it launched its UNiD ePRO service in the U.S. to provide electronic patient-reported outcomes (PROs) to spine surgeons.

The medtech giant believes its service, created through a partnership with OBERD, could change patient outcome collection. With OBERD, a practice intelligence data collection company, Medtronic hopes to reduce the burden on clinical staff and patients.

UNiD ePRO integrates with a customer’s existing electronic medical record (EMR) system in the hospital and the UNiD ASI platform. OBERD’s platform offers improved data collection methods, both pre-operatively and post-operatively. Medtronic said in a news release that it demonstrated 40%-60% increased patient response rates on average.

The platform helps to save time and increase PRO compliance without any additional burden on the staff. It provides actionable insights, too, benchmarking individu…