BlueWind posts positive follow-up study results

BlueWind Medical’s implantable tibial stimulation device

Neurostim developer BlueWind Medical reported positive results from a follow-up study of patients using its implantable tibial nerve stimulator for overactive bladder (OAB).

Renova iStim is a leadless, miniature, wireless neurostimulation platform designed for the treatment of multiple clinical indications. Three years after implantation of the BlueWind’s Renova iStim device, 75% of patients experienced at least a 50% long-term reduction in symptoms. Patients experienced a durable, long-term, effect of urinary urge incontinence relief in “leaks” (50% of patients) and in “large leaks” (80% of patients). No severe adverse events were reported throughout the follow-up study, according to the Herzliya, Israel-based company.

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FDA warns of flesh-eating genital infection linked to diabetes drug

The FDA this week warned of serious flesh-eating bacterial infections, or necrotizing fasciitis, reported by patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors intended for treating type 2 diabetes.

The federal watchdog said that between March 2013 and May 2018, 12 cases of Fournier’s gangrene, a rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat and blood vessels of the perineum, were reported by users of the drug.

Read the whole story on our sister site, Drug Delivery Business News

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Advanced Bionics wins FDA nod for MRI-safe HiRes Ultra 3D cochlear implant

Sonova Holding AG (SIX:SOON) subsidiary Advanced Bionics said yesterday that it won FDA approval for its HiRes Ultra 3D cochlear implant.

The newly approved implant is cleared for use during magnetic resonance imaging examinations as it features a new magnet design which provides alignment with an external magnetic field in any direction.

The magnet allows users to move freely around an MRI machine’s magnetic field without pain or discomfort, or the need for removal or head bandaging, Advanced Bionics said.

“After many years of research and development, the new magnet technology in our cochlear implants will improve the quality of life for our many recipients due to our hassle free and pain free magnet. We are leading the way and ensuring our recipients have the best possible experiences with our advanced technology. It’s a powerful innovation and makes our efforts so rewarding for patients,” Sonova cochlear implants group VP Hansjuerg Emch said in a press release.

Last December, Advanced Bionics said that it plans to integrate Sonova‘s Sword chip and wireless radio tech into its sound processors.

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MolecuLight wins FDA de novo nod for handheld fluorescence wound imager

MolecuLight said yesterday it won FDA de novo clearance for its MolecuLight i:X designed to assess wound surface area and help visualize harmful bacteria within the wounds.

The device is designed to improve wound assessments, which are currently made without tools, the Toronto-based company said. The system uses fluorescence to help visualize potentially harmful bacteria which may other be missed.

The device won indications from the FDA as a handheld imaging tool that allows for the diagnosis and treatment of skin wounds at the point of care. The system also allows for the viewing and digital recording of wounds traditionally and through fluorescence emitted images of wounds exposed to an excitation light.

“The MolecuLight i:X platform is a significant advancement in the management of chronic wounds, that is already revolutionizing wound care practice in Canada and Europe. Thousands of patients to date have already experienced a change in their assessment and treatment by clinicians who feel empowered by the wound fluorescence images they are seeing. As reported in multi-centered published clinical studies, clinicians used the images to inform their wound management practices in real-time, in particular, for guided wound sampling, cleaning and debridement.  We’re very excited that US clinicians will soon have the same access to this device as their peers in Canada and Europe,” founder & chief scientific officer Dr. Ralph DaCosta said in a prepared statement.

“FDA marketing authorization of the MolecuLight i:X is a monumental milestone for the wound care industry. Thanks to continued clinical studies and 17 publications to date, the clinical evidence is rapidly accumulating that the MolecuLight i:X is a must‑have device in the hands of all wound care clinicians,” CEO Anil Amlani said in a press release.

Last December, Smith & Nephew (NYSE:SNN), which distributes for MolecuLight, said it launched the MolecuLight i:X handheld imaging device in Europe.

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Report: FDA’s Gottlieb says pediatric device approvals are lagging

FDA head Scott Gottlieb said that over the past 10 years there have been “far too few” devices hitting the US market designed specifically for a pediatric population, according to a recently posted Regulatory Affairs Professionals report.

The statement came at a two-day FDA workshop this week, according to the report.

Barriers including sample size issues, regulatory concerns and problems with research infrastructure are keeping such devices from hitting the market, according to an audience poll from the workshop.

While the number for adult devices approved by the FDA grew at a rate of 3.8 per year between 2008 and 2017, pediatric devices grew at a much smaller rate of approximately 1 per year, according to RAPS.

The same trend is reflected in other submissions, including de novo and humanitarian device exemptions for pediatric patients, according to the report.

The FDA has launched initiatives looking to support development in the pediatric space, including a new division on pediatric internal medicine for drugs, according to the report. The agency is also “looking for new ways to protect children who participate in clinical trials,” Gottlieb said, according to RAPS.

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7D Surgical wins FDA nod for MvIGS nav system Cranial Module

Canadian medical device firm 7D Surgical said yesterday it won FDA 510(k) clearance for a Cranial Module for its Machine-vision Image Guided Surgery system.

The Toronto-based company’s 7D Surgical System uses 3D optical technologies which require only natural light, as well as machine vision algorithms.

The system’s navigation technology is embedded in an overhead surgical light to reduce line of sight issues, and is controlled by the surgeon using a foot pedal to eliminate the need for non-sterile personnel for operation.

“We are incredibly excited to expand the MvIGS technology to cranial surgery.  The speed, accuracy and efficiency of this new application, coupled with astounding workflow and safety improvements we have already introduced for spinal image guidance, has resulted in a very compelling and cost-effective solution for surgeons and hospitals. Faster, better and cheaper is the new mantra in healthcare and the 7D Surgical System is perfectly positioned to meet these goals,” CEO Beau Standish said in a prepared statement.

The new module is designed to acquire thousands of virtual fiducials using the patient’s own anatomy, and allows for “nearly instantaneous” cranial registration, 7D Surgical said. The system can also register multiple datasets independently, and allows for the visualization of anatomy in multiple modalities.

“This approval allows our team to offer new cranial functionality alongside our game changing spinal application to our existing and planned installations in the U.S. hospitals have been asking us for cranial, and I am delighted to be able to offer this exciting application ahead of schedule and at a price point consistent with our value proposition,” sales & marketing VP Brian Stuart said in a press release.

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Boston Scientific to submit last FDA PMA module for Lotus Edge aortic valve this month

Boston Scientific (NYSE:BSX) said today it plans to submit the final technical module for the FDA premarket approval application for its Lotus Edge aortic heart valve system by the end of next week.

The good news follows a long string of hurdles the Marlborough, Mass.-based company has faced with the Lotus over the past few years.

Last November, Boston Scientific announced news of a delay that resulted in a $3 billion drop in its market capitalization. Earlier that year in February, the company recalled the Lotus TAVR system over issues with its locking mechanism and said it didn’t expect to be able to get the device back on the market in Europe or to file for changes with the FDA by the beginning of 2018.

Boston paused Lotus implantations in October 2016 to investigate a locking mechanism issue but even though that problem was solved by January 2017, the next month the company voluntarily pulled all Lotus devices from global commercial and clinical sites “due to reports of premature release of a pin connecting the Lotus valve to the delivery system.”

This February, CEO Mike Mahoney confirmed that the Lotus will remain off the market for the rest of the year.

Today the company briefly announced progress towards new FDA approval of the valve in an SEC filing.

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Pulse Biosciences’ nano-pulse stimulation tested in skin cancer patients

Pulse Biosciences, Inc. (Nasdaq:PLSE) has begun a clinical study to evaluate nano-pulse stimulation (NPS) platform in a common skin cancer, basal cell carcinoma (BCC).

NPS is a non-thermal therapy that uses ultra-short, nanosecond-pulsed electric fields that directly affect and disrupt intracellular structures. It has been shown to induce immunogenic cell death in pre-clinical cancer models, according to the company.

Study participants will be treated with NPS prior to resection of the BCC lesion, which is the standard of care for such lesions. Post-resection tissue samples will be assessed for the elimination of the lesion in the NPS treatment zone and for biomarkers indicating an immune response to the NPS-treated lesions.

The Hayward, Calif. startup withdrew the FDA 510(k) application for its PulseTx NPS system on September 11, 2017, saying it failed to meet a deadline for submitting requested information to the agency. The company has said it intends to refile.

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Integer adds radial introducer for patients with smaller arteries

Integer’s new radial access introducer kit for interventional cardiology and peripheral vascular procedures has won FDA clearance and the CE Mark.

RadialSeal was engineered for optimal device compatibility and ease of insertion, the company said in a statement. Its thin-walled sheath design minimizes outer diameter while maximizing inner diameter, according to Payman Khales, president of Integer’s cardiovascular division. The introducer also offers easy sheath insertion through smooth transitions and hydrophilic coating, Khales added.

The device is Frisco, Texas-based Integer’s response to the limited number of viable offerings in the thin-wall introducer segment of the growing radial access market, he said.

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5 medtech stories we missed this week: July 6, 2018

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From Zetta getting FDA clearance to Prescient Medical receiving CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning.

1. Zetta wins FDA clearance for Zoom MRI software

Zetta announced in a June 25 press release that its MRI software has received FDA 510(k) clearance. The software, known as Zoom, features an algorithm for image quality enhancement and image optimization of short scanning techniques. It works with all MRI models from all major manufacturers, according to the company. Zoom’s algorithm was designed to help MRI imaging departments automatically process MRI imaging techniques.

2. MIM Software, Spectrum Dynamics Medical ink software deal for Veriton scanner

MIM Software and Spectrum Dynamics Medical have partnered to provide MIM-SD advanced visualization and quantitative processing software for the Veriton, according to a June 24 press release. Veriton is a 12 detector CZT multi-organ scanner that has unparalleled sensitivity, image quality and diagnostic accuracy. The detectors are configured for each organ and offers high resolution, lower dose and shorter acquisition times.

3. LumiThera wins CE Mark for LT-300 device for macular degeneration

LumiThera announced in a June 21 press release that it has received CE Mark for its LT-300 device that treats dry advanced macular degeneration. The device is a light delivery system. The CE Mark approval allows the company to commercialize the device in Europe.

4. RTI Surgical launches Fortilink IBF systems

RTI Surgical has launched its Fortilink-TS and -L IBF Systems, according to a June 12 press release. The systems are designed to be used in lumbar interbody fusion procedures at one or two adjoining levels in patients who have degenerative disc disease. Both systems feature the company’s TetraFuse 3D technology that is a 3D printed polymer-based interbody fusion device that uses a nano-rough surface to create more notable trabecular bone ingrowth.

5. Prescient Medical wins CE Mark for CleanCision

Prescient Surgical announced in a June 12 press release that it has received CE Mark approval for its CleanCision system. CleanCision fights and defends against surgical site infection sources. The approval allows for the commercialization of the system throughout Europe. In addition to the CE Mark approval, Prescient Surgical also received ISO 134385:2016 certification for its quality management system.

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