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…

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Smiths Medical recall affects nearly 86,000 syringe pumps with software issues

Smiths Medical issued a recall for its Medfusion Model 3500 syringe pump due to issues associated with earlier software versions.

The ICU Medical unit issued the recall as a correction — not a product removal. It affects 85,961 pumps distributed between Aug. 9, 2022, and Aug. 15, 2023. Smiths Medical initiated the infusion syringe pump recall on Dec. 19, 2023. The recall affects all those exposed to the pump, especially vulnerable patients. That includes those in the neonatal intensivecare unit (NICU) and cardiac intensive care unit (CICU) treated with Medfusion 3500.

Smiths Medical reports one injury and no deaths related to this issue, according to an FDA notice.

This latest recall follows last month’s FDA Class I recall for more than 50,000 Medfusion Model 4000 pumps. Similarly, the company recalled those models due to a software issue.

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

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Stereotaxis submits Magic ablation catheter for U.S., European approval

The Magic ablation catheter. [Image courtesy of Stereotaxis]Stereotaxis (NYSE:STXS) announced that it submitted its Magic ablation catheter for both European and U.S. regulatory approval.

The company said its FDA and CE mark submissions follow successful clinical results in an ongoing trial. Last month, Stereotaxis announced the first Magic treatments in the European trial supporting its submissions. According to a news release, the company observed “stellar” initial results in the first 20 procedures.

Stereotaxis reports 100% accurate efficacy and no adverse events with the ablation catheter in the study so far.

Magic, a robotically navigated magnetic ablation catheter performs minimally invasive cardiac ablation procedures. It incorporates design features meant to enhance patient safety, procedural effectiveness and efficacy and the physician experience.

Stereotaxis projects commercial availability for the community of robotic electroph…

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Moving the needle on diversity in clinical trials: Where do we go from here?

[Image courtesy of Adobe Stock]

Enhancing patient diversity in clinical trials has become a key priority in drug development. The main concern is that critical data that includes underrepresented patient populations is being left out as many clinical trials do not reflect all populations that may eventually take a therapy. These underrepresented groups consist of women, including those who are pregnant and lactating, pediatric and elderly patients, people with disabilities, LGBTQ+ individuals, and racial/ethnic groups specifically, Black/African American, American Indian/Alaska Natives, Hispanics/Latinos, Asians, Native Hawaiian, and other Pacific Islanders.

As a result, the U.S. government has taken increased measures with the passage of the Food and Drug Omnibus Report Act of 2022 (FDORA), which will require sponsors to submit diversity plans to the U.S. Food and Drug Administration (FDA) for all late-stage st…

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Medtronic wins FDA clearance for bone tumor ablation tech

Medtronic (NYSE: MDT) + announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system.

The medtech giant designed OsteoCool 2.0 to treat painful bone metastases and benign bone tumors like osteoid osteoma. The minimally invasive procedure uses probes to deliver radiofrequency energy that heats and destroys tumors. Meanwhile, it circulates water to cool the probes in close proximity to the active tip to avoid excess heating.

With an upgraded design, the OsteoCool radiofrequency ablation system offers a number of new advantages over the previous generation. Medtronic’s system enables the simultaneous use of four internally-cooled probes. This allows physicians to ablate two vertebral bodies at once, or create larger ablation zones in extra-spinal applications.

According to a news release, it’s the most powerful bone tumor ablation system on the market, deliverin…

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FDA approves Boston Scientific’s Agent drug-coated balloon

The Agent drug-coated balloon. [Image from Boston Scientific]Boston Scientific  (NYSE: BSX) + announced today that it received FDA approval for its Agent drug-coated balloon (DCB).

The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel.

Marlborough, Massachusetts-based Boston Scientific plans a U.S. launch for Agent in the coming months. It already has availability in Europe, parts of Asia Pacific and Latin America. The system treats patients with ISR and previously untreated small vessel coronary disease.

Agent serves as an alternative to traditional therapies like balloon angioplasty, additional layers of stenting or radiation. The paclitaxel-coated balloon transfers a therapeutic dose of drug to the vessel wall, helping to prevent ISR reoccurrence.

The FDA approved the device,…

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Onward wins FDA breakthrough nod for use of neurostim with brain-computer interface

The Onward ARC-IM neurostimulation device. [Image courtesy of Onward]Onward Medical announced today that the FDA granted breakthrough device designation for its ARC-BCI system that uses brain-computer interface (BCI) technology.

ARC-BCI uses BCI technology in conjunction with ARC-IM neurostimulation. It aims to restore thought-drive lower limb mobility after spinal cord injury (SCI). The BCI system uses AI to decode brain signals and translate them into specific instructions for the neurostimulation system. This converts the instructions into precise spinal cord stimulation.

The company describes the result as a “digital bridge” that restores communication between the brain and the body. It can enable thought-driven movement after paralysis.

Onward used clinical data from two feasibility studies to support the breakthrough nod. The company also announced the first implant of this technology in a study evaluating upper extremity function restorat…

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FDA removes dialysis-related products from device shortage list

The FDA has removed two dialysis-related product codes from its device shortage list.

The products — kidney perfusion system (product code KDN) and disposable kidney perfusion set (product code KDL) — had been on the FDA’s shortage list since January 2022.

The agency attributed the shortages to a “shortage or discontinuance of a component, part or accessory of the device” and shipping delays.

As of the May 2023 expiration of the COVID-19 public health emergency, the FDA no longer requires medical device manufacturers to report product shortages, though the agency encourages voluntary reporting of device production interruptions or permanent discontinuations.

The medical device shortages list now only includes five product codes, including automated external defibrillators (AEDs) and two types of oxygenator devices intended for extracorporeal circulation:

BYS: Oxygenators for long-term support (greater than 6 hours), added to…
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Virtual Incision wins FDA nod for miniature MIRA surgical robot for use in colectomies

[Image from Virtual Incision]Virtual Incision announced that the FDA granted marketing authorization to its MIRA miniaturized surgical robotic system.

The FDA gave the nod for the use of the miniRAS (robotic-assisted surgery) device in adults undergoing colectomy procedures. MIRA went through the FDA’s de novo classification process, with findings based on an investigational device exemption (IDE) study.

Virtual Incision’s MIRA system features a small, self-contained surgical device. Inserted through a single midline umbilical incision in the patient’s abdomen, it allows for complex, multi-quadrant abdominal surgeries. The system also uses existing minimally invasive tools and techniques that are familiar to surgeons. Altogether, MIRA weighs about two pounds.

According to the company, the system’s tray-to-table design could provide the advantages of robotic surgery without requiring them to organize the operating room around the device — a…

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New ClearPoint Neuro software wins FDA clearance, used in first cases

The Maestro Brain Model as part of the ClearPoint 2.2 software. [Image courtesy of ClearPoint Neuro]ClearPoint Neuro (Nasdaq:CLPT) announced that the FDA cleared its ClearPoint 2.2 software with integrated Maestro Brain Modeling.

The Solana Beach, California-based company also reported the first-in-human cases following the FDA clearance.

ClearPoint Neuro President and CEO Joe Burnett said the system now offers fast, peri-procedural segmentation of the cortical structures of the brain. This helps to identify targets and safety zones for cell and gene therapy delivery, laser ablation, biopsy and deep brain stimulation.

According to the company, MRI-guided neuro interventions need rapid, accurate and reproducible segmentation of brain structures. Maestro demonstrates superior performance compared to both manual expert segmentation and FreeSurfer, according to quantitative analysis.

The company expects a full market release of ClearPoint 2.2 in the seco…

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FDA: don’t use smartwatches,smart rings to measure blood glucose

[Photo by Simon Daoudi on Unsplash]The FDA issued a warning to consumers, patients, caregivers and providers around using certain technology to measure blood glucose.

In the warning, the agency outlined the risks related to using smartwatches or smart rings for this purpose. Such devices may claim to measure blood glucose levels without piercing the skin. These devices are different from smartwatch applications that display data from FDA-authorized blood glucose measuring devices like CGMs.

The FDA says that, to date, it has not authorized, cleared or approved any smartwatch or smart ring intended to measure or estimate blood glucose values on its own. People with diabetes receiving inaccurate blood glucose measurements can experience errors in their diabetes management. That includes incorrect insulin dosing, sulfonylureas or other medications.

According to the FDA notice, consumers should not buy or use these devices that claim to measure blood glucose le…

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Better Therapeutics wins FDA breakthrough nod for liver disease-treating digital therapeutic

Better Therapeutics (Nasdaq:BTTX) announced today that the FDA granted breakthrough device designation for its MASH treatment.

The company’s prescription digital therapeutic (PDT) delivers novel cognitive behavioral therapy (CBT). It aims to treat adults with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH.

This novel form of CBT targets the lifestyle behaviors known to cause and/or contribute to the progression of metabolic diseases. The company developed its platform to address the current gap in broadly accessible and standardized intensive behavioral therapies that effectively enable the implementation of existing treatment guidelines that call for behavior change as the foundation of treatment. Its AspyreRx PDT for type 2 diabetes received FDA clearance and launched last year.

Better Therapeutics said in a news release that it earned a breakthrough nod based on the outcomes of its LivVita clinical study. The tri…

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