Cantel Medical wins FDA nod for Advantage Plus endoscope reprocessor

Cantel Medical (NYSE:CMD) said today it won FDA 510(k) clearance for its Advantage Plus pass-thru automated endoscope reprocessor, making it the first AER available in the US, the company claims.

The newly cleared device is designed for the high-level disinfection of commonly used endoscopes, including duodenoscopes, the Little Falls, N.J.-based company said.

“We strive to deliver real life infection prevention solutions to address the complexities our customers face in setting up successful endoscopy departments. We believe the Advantage Plus pass-thru AER’s availability will transform our customers’ experiences by improving department efficiencies and workflow while maintaining the integrity of the cleaning process and supporting patient safety,” global marketing and biz dev VP Bill Haydon said in a prepared statement.

The Advantage Plus pass-thru AER uses a one-way workflow to reduce human error with a hard-wall separation between dirty and clean reprocessing areas to prevent recontamination of reprocessed endoscopes, Cantel said.

The system is designed to reprocess approximately four to five scopes per hour, and has been cleared for use with Cantel’s Rapicide PA disinfectant.

“The FDA clearance of Advantage Plus pass-thru AER further expands our rapidly growing endoscopy portfolio and delivers on our commitment to safeguard the world from infections through innovative, market leading technologies. As a leader in infection prevention for over 20 years, Cantel is thrilled to announce the availability of this best practice technology in automated endoscope reprocessing to our U.S. customers,” endoscopy division prez Dave Hemink said in a press release.

Last month, Cantel said it acquired Belgium-based healthcare software developer Aexis Medical in a deal worth $24.8 million.

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UroViu wins FDA nod for disposable diagnostic cytoscope

UroViu said yesterday it won FDA 510(k) clearance for its Uro-V single-use diagnostic cytoscopic system designed to visually assess the urethra and urinary bladder in instances of suspected pathology or dysfunction.

The Bellevue, Wash.-based company’s newly cleared Uro-V device is a self-contained single-use diagnostic cytoscope designed for female diagnostic cytoscopy. The system is designed to be light-weight, portable and battery powered with a disposable cannula and a reusable handle, video processor, LCD display and touchscreen display.

“Today’s growing and aging population faces a severe problem of an increasing shortage of urologists. The Uro-V Cystoscope has great potential to make the standard urological care more accessible and convenient for the patients while greatly reducing the burden of the urologists and staff,” Dr. Marshall Stoller of the University of California San Francisco said in prepared remarks.

UroViu said it has completed a prospective, observational open-label usability study of 64 subjects who were candidates for office diagnostic cytoscopy at 2 centers in the US and Europe. Results from the study were completed without incident or adverse reactions, the company said.

“Our group of 12 providers made the decision to change to disposable sheaths after critical review of single-use versus reusable scopes, finding significant advantages clinically and economically: safer for patient, ease of use for staff, decreased preparation time, overall decreased cost to provider, with higher safety margin—faster turnover of procedure room, equipment, improved patient time efficiency, increased revenue—lower overall cost, increased number of cystoscopy procedures per day and I think that Uro-V will further improve the single-use model—better visualization digital vs analog, less risk of scope malfunction, improved prep time even compared to single-use sheath (which still requires cleansing scope prior to overlaying scope), ability to show in real time to patient operative findings,” trial principal investigator Dr. Vijay Goli of the University of Nevada School of Medicine said in a prepared release.

“The device was easy to use; my staff preferred it due to easy set up and off-the-shelf availability, and patients were satisfied due to less discomfort than they experienced with standard scopes,” trial principal investigator Dr. Jed Kaminetsky of Manhattan Medical Research said in a press release.

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5 medtech stories we missed this week: Jan. 26, 2018

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From Attune Medical receiving FDA 510(k) clearance to Synapse Medical having CE Mark approval, here are 5 medtech stories we missed this week but thought were still worth mentioning.

1. Attune Medical gets FDA 510(k) clearance

Attune Medical announced in a Jan. 8 press release that it has received FDA 510(k) clearance for its EnsoETM model that administers tube feeds or medication while cooling or warming patients. The device manages a patient’s temperature through the esophagus while allowing for enteral fluid administration with the company’s ENFit connector.

2. Ally Bridge, LifeTech Scientific ink strategic Chinese partnership deal

Ally Bridge has entered a strategic partnership with LifeTech Scientific in China to help with commercialization and market entry in China, according to a Jan. 7 press release. Through the agreement, LifeTech has committed to invest in Ally Bridge funds and will continue to invest in other medtech companies. Additionally, ABG and LifeTech will set up a joint investment Fund to invest in other medical technologies globally.

3. ResMed launches Mobi portable oxygen concentrator

ResMed announced in a Jan. 8 press release that it has released its first portable oxygen concentrator, the Mobi. Mobi will be available to patients in the U.S. through home medical equipment providers and is currently in the process of getting clearance to launch the product in other countries.

4. Axonics wins Australian nod for sacral neuromod

Axonics has won Australian marketing approval for its Sacral Neuromodulation System, according to a Jan. 8 press release. The device is designed to treat overactive bladder, fecal incontinence and urinary retention. The approval allows the company to commercialize the device throughout Australia.

5. Synapse Biomedical gets CE Mark approval

Synapse Biomedical announced in a Jan. 8 press release that it has received CE Mark approval for its TransAeris System. The TransAeris system is a temporary diaphragm stimulator that is designed to be used in ICU patients who are on mechanical ventilation. The system gives patients life-sustaining respiration.

Here’s what we missed last week.

Hitachi wins FDA nod for proton beam therapy real time image gating system

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Hitachi (NYSE:HIT) said this week it won FDA 510(k) clearance for its Real Time Image Gating System designed for use with its proton beam therapy systems.

Real Time Image Gating Proton Beam Therapy is designed to track and irradiate tumors in motion, using a 2mm diameter gold marker close to the tumor to establish its location as a reference via computed tomography.

A dual-axis, orthogonal X-ray system is then used with pattern recognition software to identify the spatial location of the marker, and irradiation during treatment is performed only when the gold marker moves to within millimeters of the planned irradiation location.

Development of the technology was sponsored in part by a grant from the Funding Program for World-Leading Innovative R&D on Science and Technology in 2010, sponsored by the Japanese Government. The grant was awarded to a joint project between Hitachi and Hokkaido University.

Hitachi won clearance for the RGPT technology from Japan’s Pharmaceuticals Medical Device Administration in 2014.

“Hokkaido University has been developing motion tracking technology in the field of X-ray therapy. By combining this technology with Spot Scanning technology, the accurate irradiation of tumors, including those attached to large organs in motion which are difficult to irradiate with X-rays, will be possible and will lead to greater adaptation. I am very pleased that this innovation for highly precise irradiation will become broadly available around the world,” Hokkaido Univeristy Hospital research group director Dr. Hiroki Shirato said in a prepared statement.

Hitachi said that with the clearance, it is moving forward with plans to install RGPT systems at facilities under construction in the US.

7 medtech stories we missed this week: Jan. 19, 2018

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From Privi Medical’s FDA clearance to OrthoXel getting FDA clearance and CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Privi Medical wins FDA nod for hemorrhoid device

Privi Medical has received FDA clearance for its Instalief Hemorrhoids Treatment device, according to a Jan. 18 news release. The device is disposable and uses an advanced instant cold compression technology to treat hemorrhoids.

2. Centric Medical gets FDA 510(k) clearance for foot & ankle screws

Centric Medical announced in a Jan. 16 news release that it has received FDA 510(k) marketing clearance for its Cannulated Screw Internal Fixation System. The system features foot and ankle screws that can be used in foot and ankle reconstruction procedures. It is a multi-component system made of titanium alloy that comes in a variety of diameters and lengths.

3. BioPoly receives CE Mark for knee implants

BioPoly has received CE Mark for its RS Partial Resurfacing Trochlea system, according to a Jan. 16 news release. The partial resurfacing knee portfolio can treat focal cartilage defects in femoral condyles, trochlear facts, trochlear groove and patella. The company plans to launch the system in the next few months.

4. Avacen launches dry-heat therapy autism device in India

Avacen announced in a Jan. 17 press release that it has launched its Avacen 100 dry-heat therapy autism device in India. The device is an FDA-cleared, CE Mark Class II therapy device designed to provide relief of autistic behavior. Avancen 100 safely and non invasively warms the body by infusing heat into the circulatory system. The device has been shown to improve speech impediments, increase classroom participation and an improvement of school grades.

5. FDA approves Zoll Medical’s full AED line

Zoll Medical has received premarket approval from the FDA to market and distribute its full line of defibrillators in the U.S., according to a Jan. 9 press release. The company’s R Series, X Series, AED Pro and AED Plus have all received premarket approval. Each device uses Zoll’s rectilinear biphasic waveform to deliver maximum current to high-impedance patients.

6. Sealantis wins CE Mark for surgical sealant

Sealantis announced that it has received CE Mark for its Seal-G surgical sealant, according to a Jan. 12 press release. The sealant is designed to reduce leaks after gastrointestinal procedures. Seal-G stops anastomotic leaks by reinforcing suture or staple lines during post-surgery. The sealant will be available in Europe as it has not yet received FDA approval.

7. OrthoXel wins FDA nod, CE Mark for Apex tibial nailing device

OrthoXel announced in a Jan. 16 press release that it has received FDA 510(k) clearance and CE Mark approval for its Apex Tibial Nailing System. The company can now commercialize the system in the U.S. and Europe. The device allows surgeons to have a wide range of locking options of intramedullary nail. Its micromotion locking mode allows for controlled axial movement with torsional stability.

NuVasive wins expanded FDA nod, launches interbody fusion devices

NuVasive Inc. (NSDQ:NUVA) said today it won expanded FDA 510(k) clearance for its Cohere cervical interbody fusion device and that it launched the Coalesce thoracolumbar interbody fusion device.

Both the launch and updated clearance comes from the company’s acquisition of Vertera Spine, which it closed last September.

The Cohere and Coalesce implants use porous version of the material polyetheretherketone, or PEEK, and are designed to provide three-dimensional achitecture to elicit and encourage bone growth, San Diego, Calif.-based NuVasive said.

“Our strategy in building our AMS portfolio is to provide unprecedented, innovative technologies that enhance the surface, structure and visualization properties of these implants. Our launch of Coalesce and the expanded clearance of Cohere and Coalesce are all part of our continued commitment to bring disruptive technology to market and investment into our comprehensive AMS portfolio, which converge to provide a better surgical experience and improve patient quality of life,” chair & CEO Gregory Lucier said in a prepared statement.

The company said that the Coalesce device is now available for TLIF and PLIF procedures in multiple footprints, heights and lordotic options. Its indications include use for one or two adjacent levels in the thoracolumbar spine with both autograft and allograft for treating degenerative disc disease and degenerative spondylolisthesis and multi-level degenerative scoliosis.

NuVasive said that the expanded FDA indications for its Cohere device clear it for use at multiple levels in the cervical spine with both autografts and allografts.

“Patients can gain significant pain relief and improved functional outcomes through the stabilization and fusion of the degenerated spinal motion segment. Cohere and Coalesce contribute to these outcomes by retaining the biomechanical properties necessary for intradiscal spinal applications, while helping facilitate osseointegration and bone growth. The use of these new Porous PEEK implants may enhance fusion and limit the risk of stress-shielding, subsidence and implant failure,” Dr. Kenneth Burkus of The Hughston Clinic said in a press release.

Last month, NuVasive said it inked a deal to acquire intraoperative neurophysiological monitoring service provider SafePassage for an undisclosed amount.

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Mevion wins FDA 510(k) for S250i proton therapy system

Mevion Medical Systems said yesterday it won FDA 510(k) clearance for its Mevion S250i proton therapy system featuring pencil beam scanning technology, and touted that the first unit was installed at MedStar Georgetown University Hospital in Washington D.C.

The Mevion S250i features improved pencil beam scanning fields and Hyperscan pencil beam scanning tech to allow for faster energy layer switching, the Littleton, Mass.-based company said.

“The S250i system represents the next generation of intensity modulated proton therapy (IMPT) delivered in the most compact proton therapy platform. We are proud that the MEVION S250i system now has received both FDA clearance and CE mark. This is a very important milestone in our efforts to make precision proton therapy available to more patients in the fight against cancer,” CEO Joseph Jachinowski said in a prepared statement.

The system also features the company’s Adaptive Aperture multi-leaf collimator designed for multi-layer conformal field delivery, Mevion said, which it claims provides dose gradients with up to 3 times sharper lateral penumbra.

Mevion said that the system installed at MedStar Georgetown University Hospital is undergoing onsite testing this month, and will be operable after the testing is completed.

“We are excited to be not only the first and only proton therapy system in the Washington, D.C. area, but also the first in the world to offer these advanced proton therapy treatment capabilities to our patients and community. Currently, patients who seek proton therapy need to leave the metropolitan D.C. area, which can be a significant burden on families. We will now be delivering advanced proton therapy, fully integrated into our broad set of comprehensive cancer care offerings. This is critical to the patients we serve,” Dr. Brian Collins of the MedStar Georgetown Proton Therapy Center said in a press release.

The company submitted an application seeking 510(k) clearance last September.

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Pavmed files FDA 510(k) for CarpX carpal tunnel device

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Pavmed (NSDQ:PAVM) said today it filed a 510(k) application with the FDA for its CarpX minimally invasive device designed to treat carpal tunnel syndrome.

The CarpX is a percutaneous device designed to allow the operating physician to relieve compression of the median nerve without a surgical incision. The system combines a balloon catheter with bipolar radio-frequency cutting electrodes and is positioned through guidance with ultrasound, the company said.

“I have had the opportunity to use Pavmed’s highly innovative CarpX device in pre-submission testing and am very impressed with its performance. As a busy hand surgeon, I strongly believe that CarpX will be a game-changer in the treatment of carpal tunnel syndrome, providing patients with a much less invasive option and significantly shorter recovery times than traditional open carpal tunnel surgery. I eagerly await CarpX’s regulatory clearance and the opportunity to offer this ground-breaking innovation to my patients suffering from carpal tunnel syndrome,” Dr. David Kelly of Gilbert, Ariz.’s Center for Dermatology and Plastic Surgery said in a press release.

Upon activation, the CarpX device creates a space within the tunnel to confirm the nerve is protected from the cutting electrode and decompresses the median nerve by dividing the transverse carpal ligament.

“We designed CarpX to closely mimic the anatomic results of traditional invasive carpal tunnel surgery but to do so much less invasively, using catheters, balloons, radiofrequency energy and other established tools that have contributed to the percutaneous and minimally invasive revolutions in the treatment of other conditions. Our balloon catheter device is designed to be inserted under the scarred ligament in a minimally invasive fashion, while pushing the nerve and tendons away. When activated, bipolar radiofrequency electrodes precisely cut the ligament from the inside out in a matter of seconds. The device design provides physicians with ongoing feedback to optimize the safety and completeness of the procedure,” Pavmed chief medical officer Dr. Brian deGuzman said in prepared remarks.

Pavmed said it is hopeful that the CarpX device can decrease costs and move procedures out of operating rooms, as well as decreasing postoperative pain and hospital stays before patients can return to their day-to-day lives.

“We are very excited to have reached this most important milestone in Pavmed’s corporate history. CarpX has become the most commercially promising and clinically exciting product in our pipeline and we believe it will revolutionize the treatment of carpal tunnel syndrome, a widely prevalent condition that exacts a significant clinical and economic burden on society in the U.S. and worldwide. Based on epidemiological and market research data we estimate CarpX’s addressable market opportunity to exceed $1 billion,” Pavmed chair & CEO Dr. Lishan Aklog said in a prepared statement. “As with all of our products, CarpX’s development and regulatory testing were performed using our unique business model focused on speed to market and capital efficiency. We are proud to have achieved this milestone within a timeframe and with capital expenditures to date that beat our model’s benchmarks. We believe we have assembled a strong submission and are targeting clearance in the first half of 2018. Upon successful regulatory clearance, we anticipate an aggressive commercialization strategy using well-established independent sales channels targeting the appropriate physician specialties.”

Earlier this month, Pavmed saw shares rise after the medical device maker beat expectations on Wall Street with its third quarter results

Masimo wins FDA nod for NomoLine capnography sampling lines

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Masimo (NSDQ:MASI) said today it won FDA clearance for its NomoLine capnography sampling lines.

The newly cleared NomoLine sampling lines are compatible with both Masimo and third-party OEM NomoLine monitors to allow for sidestream capnography and gas monitoring the Irvine, Calif.-based company said. The lines are designed for both intubated and non-intubated patients in low and high humidity applications.

Masimo touted that the NomoLine sampling lines feature no-moisture sampling technology designed to eliminate issues associated with conventional sidestream gas sampling line systems. The NomoLines feature the company’s patented polymer and allow water in sampling lines to continuously evaporate into the surrounding air and leave oxygen, carbon dioxide and anesthetic gases unaffected.

“With NomoLine, we’ve developed innovative moisture-wicking technology – and then applied that breakthrough to an entire line of cannulas, including neonatal airway adapter sets. Masimo continues to automate noninvasive monitoring with solutions such as NomoLine that are reliable and easy to use,” founder & CEO Joe Kiani said in a press release.

Earlier this month, Masimo reported third-quarter results that crushed the consensus earnings forecast and raised its sales and earnings outlook for the rest of the year.

7 medtech stories we missed this week: Nov. 17, 2017

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From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Skyline Medical launches JV deal with Helomics

Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. The agreement comes after a strategic collaboration between the companies that allows Skyline to reach more markets. The joint venture leverages the Helomics D-Chip platform to develop and market new approaches for personalized cancer diagnostics and care.

2. iReliev launches wearable arthritis-treatment EMS/Tens patch

iReliev recently introduced its PlayMakar Wireless EMS + TENS Unit that helps treat chronic pain from arthritis on the go, according to a Nov. 15 press release. The device features two functions that include transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). TENS helps block pain signals from the brain to provide pain relief while EMS stimulates muscles for conditions, strengthening and recovery using gentle electrical impulses. It has two rechargeable receivers that connect to electrode pads to allow for it to work wirelessly. The device has 14 preset therapy mode for personalized treatment and additional receivers can be added on for treating bigger areas.

3. Mortise Medical gets FDA clearance

Mortise Medical announced in a Nov. 14 press release that it has received FDA 510(k) clearance for its SyndesMetrics Syndesmosis Repair System. The system addresses clinical needs for syndesmotic disruption injuries like predictable and repeatable anatomic reduction, restoration of physiological motion and restoration of ankle stability. The SyndesMetrics implant system has minimal hardware prominence, no suture prominence and a reversible locking mechanism that secures high strength suture that that connects tibial and fibular implant components.

4. InnerScope announces new distribution deal

InnerScope Hearing Technologies has announced that it has signed an exclusive distribution deal with Speechlab Advanced Technologies, according to a Nov. 14 press release. The deal allows for resell rights of InnerScope’s BlackCat Personal Sound Amplifier Product (PSAP). The BlackCat is a personal audio controller that is designed to help people understand speech better in noisy environments.

5. Mevion receives CE Mark for proton therapy system

Mevion announced in a Nov. 13 press release that it has achieved CE Marking clearance for its Mevion S250i Proton Therapy System. The system features Hyperscan technology and pencil beam scanning (PBS) for faster, sharper and more robust proton treatments. It also uses the fastest energy layer switching, optimized spot sizes and the Adaptive Aperture proton multi-leaf collimator system.

6. Nexstim wins FDA nod for NBT depression device

Nexstim has been cleared by the FDA to market and distribute its Nexstim NBT system, according to a Nov. 13 press release. The system is designed to treat major depressive disorder through stimulation of the brain using repetitive transcranial magnetic stimulation (TMS), which has been proven to be effective in treating depression. The company plans to begin to market and sell its system in early 2018.

7. Lensar gets FDA clearance, CE Mark for laser eye surgery marker

Lensar announced in a Nov. 10 press release that it has received FDA 510(k) clearance and CE Mark for its IntelliAxis-L. It is a unique reference mark that uses the company’s integrated pre-operative diagnostic capabilities, iris registration and intraoperative imaging to identify the location of steep corneal axis at the capsular plane for toxic IOL alignment.