FDA Archives - Page 5 of 103 - Medical Design Sourcing

How alcohol could make renal denervation for hypertension faster and simpler

Ablative Solutions President and CEO Kate Rumrill [Photo courtesy of Ablative Solutions]

Ablative Solutions is developing the Peregrine renal denervation (RDN) system to treat hypertension. The company hopes to follow Recor Medical and Medtronic in winning FDA approval for the system.

“As a small company, it’s definitely better to be a fast follower than it is to be first to market,” Ablative Solutions CEO Kate Rumrill said in an interview. “I’m excited for Medtronic and Recor and their first year of sales and having these larger companies out there, doing some of that early work as far as market awareness and market adoption.”

Medtronic’s Symplicity Spyral RDN system uses radiofrequency (RF) energy, while Recor’s Paradise system uses ultrasound. Peregrine doesn’t deliver energy at all, instead using alcohol as a neurolytic agent.

“There …

Dexcom submits new glucose sensor to FDA, expects launch this summer

The Stelo glucose monitor. [Image courtesy of Dexcom]Dexcom (Nasdaq: DXCM) + announced that it submitted its new Stelo glucose sensor to the FDA for review at the end of last year.

The continuous glucose monitor (CGM) maker designed Stelo specifically for people with type 2 diabetes who do not use insulin. San Diego-based Dexcom designed Stelo for a 15-day wear with a cash-pay option. It features a software experience tailored specifically for non-insulin users.

In early 2023, Dexcom Chair, President and CEO, Kevin Sayer hinted at potential new avenues when speaking to Drug Delivery Business News. He explained that the company wanted to broaden its focus, even revising its mission statement.

At the company’s June Investor Day event, it revealed its plans to bring the new product to market in the U.S. in 2024. According to Dexcom, the target population includes approximately 70% of Americans with diabetes.

…

Embecta submits insulin patch pump for FDA clearance

Embecta (Nasdaq:EMBC) announced today that it submitted a 510(k) premarket filing to the FDA for its proprietary insulin patch pump.

The Parsippany, New Jersey-based BD Diabetes spinoff developed a proprietary, disposable pump for people with type 2 diabetes. The company provided analysts with some details on the makeup of the open-loop system earlier this year. It also has a closed-loop version under development to follow. That version features an embedded algorithm that requires Embecta to run a clinical study.

Embecta describes the pump as convenient and discreet, featuring a 300-unit insulin reservoir. Embecta designed it to lighten the burden of managing diabetes while improving user outcomes. Colleen Riley, the company’s CTO, said the pump design is informed by “the unique needs” of people with type 2 diabetes and their healthcare providers.

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

Insulet has a Class I recall for the Omnipod 5 Android App

Insulet’s Omnipod 5 with the Dexcom G6 CGM. [Image from Insulet]The FDA labeled a recall of the Insulet (NYSE: PODD) + Omnipod 5 App for Android smartphones as Class I, the most serious kind.

Insulet’s recall — a correction, not a product removal — affects software versions 1.1-1.2.3 for the Omnipod 5 automated insulin delivery system. It distributed the software between April 20, 2023, and Dec. 20, 2023. The company initiated the recall, which affects 28,919 devices in the U.S., on Nov. 7, 2023.

The Omnipod 5 App uses SmartAdjust technology to help adjust insulin delivery based on real-time and future blood sugar levels. Its SmartBolus Calculator computes recommended bolus doses, while the app considers user-inputted carbohydrates and other sensor data. The recalled app is an Android-based software provided on either a locked-down controller or downloaded on a smartphone. Its uses include activating/deactivat…

FDA clears next-gen handheld ultrasound from Butterfly Network

A teaser image of the iQ3 handheld ultrasound system. [Image courtesy of Butterfly Network]Butterfly Network (NYSE:BFLY) announced today that it received FDA clearance for its next-generation handheld ultrasound system.

BFLY shares were up more than 23% to $1.25 apiece on the news. MassDevice‘s MedTech 100 Index was up more than 1%.

The Butterfly iQ3 point-of-care ultrasound (POCUS) system marks the third iteration of the company’s technology. Burlington, Massachusetts- based Butterfly develops semiconductor-based, single-probe, whole-body ultrasound technology. iQ3 features a brand-new ergonomic design and provides double the data processing speed compared to previous generations.

According to a news release, the new system optimizes image resolution, sensitivity and penetration. It also enables faster 3D capabilities to power novel, automated image capture modes called iQ Slice and iQ Fan.

Butterfly’s technology goes beyond just p…

SimBioSys wins FDA nod for TumorSight precision medicine platform

SimBioSys announced that it received FDA 510(k) clearance for its TumorSight cloud-based digital precision medicine platform.

FDA clearance came just days after the company inked a partnership with Mayo Clinic to develop precision medicine solutions.

The TumorSight platform takes a patient’s standard-of-care imaging to build a custom 3D model of their tumor. The tool provides 3D spatial visualizations of breast cancer to support more effective planning and consultations. SimBioSys said it gives clinicians and patients a more comprehensive understanding of their cancer and the potential options available.

Additionally, the TumorSight application provides insights like tumor volume, tumor-to-breast volume and tumor distance to key anatomical structures. It quantifies key metrics required in treatment planning.

SimBioSys also plans to expand the TumorSight platform and incorporate a suite of innovative tools. Those tools could extend to surgical plan…

Endotronix submits pulmonary artery sensor for FDA premarket approval

The Cordella system. [Image courtesy of Endotronix]Endotronix announced today that it submitted a premarket approval (PMA) application to the FDA for its Cordella system.

Cordella, a pulmonary artery (PA) sensor system, enables proactive, data-driven heart failure (HF) management. It engages patients, reduces and prevents congestion and improves outcomes.

The Cordella system delivers proactive PA pressure data and non-invasive vital health data for at-home HF management. Its user-friendly devices securely transmit daily health information to the managing clinician as well. This supports the optimal dosing of guideline-directed medical therapy, reducing congestion and engaging patients.

In April, Endotronix completed enrollment in its Proactive-HF pivotal study supporting its application for FDA premarket approval. Endotronix said that Proactive-HF enrolled more than 450 patients across the U.S., Ireland and Belgium. The study’s primary endpoints include mor…

Nanowear wins FDA nod for AI-enabled wearable blood pressure monitor

The SimpleSense wearable platform. [Image courtesy of Nanowear]Nanowear announced today that its SimpleSense nanotechnology-enabled wearable and software platform received FDA 510(k) clearance.

The AI-enabled non-invasive, cuffless, continuous blood pressure monitor and diagnostic offers a tool in the diagnostic management of hypertension. It adds to the wearable platform’s previously cleared cardiopulmonary diagnostics. The FDA cleared it as software as a medical device (SaMD).

SimpleSense captures and analyzes more than 85 unique biomarker data points. It ranges across the heart, lungs, hemodynamic and central vascular system. The platform provides continuous, time-synchronous biometric data.

According to Nanowear, SimpleSense aggregates millisecond-by-millisecond cardiopulmonary assessments. This assists medical professionals in remote patient management. With proprietary nanosensors and algorithms, SimpleSense could offer an alternative to first-l…

FDA clears new MR scanner from Siemens Healthineers

The Magnetom Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner. [Image courtesy of Siemens Healthineers]Siemens Healthineers announced today that the FDA cleared its Magnetom Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner.

Magnetom Cima.X includes the strongest-ever gradients system for a clinically released whole-body MR scanner, according to a news release. This makes smaller structures in the body visible and captures images faster than previous MR scanners. Other design features enhance scientific research and overcome key imaging challenges to visualize cancer and other diseases.

Siemens Healthineers designed its Gemini Gradients for the scanner to register 2.5 times higher than its previous strongest MR gradients in terms of amplitude. They have an amplitude of 200 mT/m and a slew rate of 200 T/m/s. This enables clinicians to better study neurodegenerative diseases, increasing the visibility of microstructures. Users can le…

FDA expects longer AED shortage, reports plans for Abbott HeartMate II discontinuation

The FDA now expects shortages of automated external defibrillators (AEDs) to persist longer than previously estimated, but removed four other product types from its list of medical device shortages.

The agency also added to its list of discontinued devices, including plans by Abbott to stop manufacturing its HeartMate II Left Ventricular Assist System (LVAS) in 2026.

AED shortage update

The FDA said shortages of wearable and non-wearable AEDs (product codes MVK and MKJ, respectively) will likely last through summer 2024. The federal agency updated its forecast last month after saying as recently as October that the shortage would last through 2023.

The FDA said the shortages are due to an increase in demand for the devices as well as a shortage or discontinuance of a component, part or accessory. Those devices have been on the shortage list since July 2022 as the agency required manufacturers to file for premarket approval (PMA) for previously cleared ac…

FDA says not to use certain hip implants from Synovo

The FDA today issued recommendations for providers considering using the Total Hip System and its implants made by Synovo.

Its recommendations also apply to patients who received certain implants used in the system after 2019. Three components — the femoral resurfacing cup, acetabular fixation cup and acetabular bearing — have been significantly modified from the devices initially cleared by the FDA, the agency’s notice said.

According to the FDA, the safety and effectiveness of the system and its components have not been established. Other names for the system include the total hip replacement system, Synovo Preserve and Endotec BP.

The FDA became aware of the modifications made to the components in 2022. Following an inspection, the agency issued a warning letter to Synovo. The letter listed several violations and instructed the company to immediately stop manufacturing the modified devices. The FDA urged the company to take prompt action and cor…

Report: Concerning chemicals found in replacement Philips CPAPs

The Philips DreamStation 2 continuous positive airway pressure (CPAP) device [Photo courtesy of Philips]Replacement machines issued by Philips (NYSE: PHG) + amid its respiratory device recall may have more issues, according to ProPublica and the Pittsburgh Post-Gazette.

Philips Respironics has recalled more than 5 million devices since 2021 due to dangerous degradation of sound abatement foam. The FDA has received more than 100,000 reports of problems related to the recall, including at least 385 linked to deaths.

While the company continues to work through its remediation process, more light has been shed on how the recall unfolded as it did. ProPublica and the Pittsburgh Post-Gazette first reported that Philips withheld its CPAP issues from the FDA for years. The reporting later revealed CEO Roy Jakobs’ apparent knowledge of the ongoing issues and alleged approval of the sale of defective devices.

The latest repo…