7 medtech stories we missed this week: August 11, 2017

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From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention.

1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant

Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions for the Calix-C cervical inter body cages. The clearance allows for two larger footprints to be added for use with allograft. The Calix-C Cervical Interbody Spacer is designed for spinal fusion procedures at level one in patients who are skeletally mature. It is supposed to be used with spinal fixation systems like Xtant Medical’s Spider Cervical Plating and Certex Spinal Fixation Systems.

2. Life Spine touts first use of TiBow spacer

Life Spine has announced the first clinical use of its TiBow MIS TLIF Expandable Spacer System with Osseo Loc Surface Technology in an Aug. 8 press release. TiBow is designed for in-situ expansion for increased endplate coverage and stability for minimally invasive TLIF and oblique approaches. It gives the surgeon the ability to restore sagittal alignment.

3. Cardiac Science inks deal to supply AEDs to Philadelphia schools

Cardiac Science announced in an Aug. 8 press release that it has reached a deal with the School District of Philadelphia to make automated external defibrillators (AEDs) available in all 220 Philadelphia schools. Philadelphia’s high schools and middle schools already have the Cardiac Science Powerheart G3 and G5 AEDs in place and the elementary schools are set to receive the company’s Powerheart G5 units.

4. ApiFix wins nod in Australia

ApiFix has received TGA certification through its Orthotech Pty. distributor to market the ApiFix system in Australia, according to an Aug. 8 press release. The ApiFix system is designed to treat and correct adolescent idiopathic scoliosis (AIS) using a minimally-invasive surgical approach. The system is a non-fusion spinal implant system that is designed to improve the quality of life of patients who have to have scoliosis surgery.

5. Pentax Medical launches slim linear ultrasound

Pentax Medical announced in an Aug. 9 press release that it has launched its new Slim Linear Ultrasound Endoscope in the U.S. The endoscope features a smaller insertion tube, a smaller distal end and a shorter bending section to help endoscopies see and reach hard-to-access anatomy.

6. Hip Innovation launches clinical trial of novel hip replacement system

Hip Innovation Technology has started its clinical trial to evaluate the effectiveness and safety of the HRS lead hip replacement system, according to an Aug. 9 press release. The clinical study will include 100-120 patients who are scheduled to receive a total hip arthroplasty. The company plans to test effectiveness using clinical radiologic, radiostereometric and patient-reported outcomes. It will measure safety through collecting device-related adverse events. They will also assess the quality of life of each patient.

7. Varian Medical inks distribution deal with Bionix radiation therapy

Varian medical Systems announced in an Aug. 9 press release that it has entered an agreement with Bionix Radiation Therapy to distribute the Bionix brachytherapy applicators in North America. Varian has agreed to market the Bionix Esophageal Application (E-App) and the Anorectal Applicator (AR-1). E-App is a disposable brachytherapy applicator that is designed to treat upper GI cancers. It has five independently operated balloons that help maintain the central position of source catheters in straight and curved anatomy. AR-1 is a disposable brachytherapy applicator that is designed to treat anal and rectal cancers. It allows for exophytic tumors to press closer to a source catheter to deliver a very high dose to the tumor while keeping healthy tissues safe.

Here’s what we missed last week.

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Renovis wins FDA nod for Tesera lumbar interbody fusion systems

Renovis Surgical Technologies said today it won FDA 510(k) clearance for its Tesera lumbar porous titanium interbody fusion systems.

The Redlands, Calif.-based company said its newly cleared Tesera devices feature implants designed for direct posterior or transforaminal approaches, and includes straight and curved options in multiple heights, widths and lengths.

The Tesera devices are produced using 3D printing techniques and feature the company’s Tesera trabecular technology designed to improve bone attachment and the potential for biologic fixation, according to a press release.

Renovis said the clearance is the 5th for the company.

See the best minds in medtech live at DeviceTalks Boston on Oct. 2.

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Soterix Medical wins FDA 510(k) for IontoDC


Soterix Medical

Soterix Medical said today it won FDA 510(k) clearance for its IontoDC device designed to use direct current to introduce ions of soluble salts and other drugs  into the body.

The New York-based company said that the newly-cleared IontoDC device provides 10, 20, 30 or 40 minutes of direct current at intensities varying between 1 and 2 mA, and includes resistance meters and automatic ramp up and down.

“This clearance represents a significant milestone for our organization as we can now offer the IontoDC system to the medical community in the U.S. The IontoDC was designed for ease-of-use including simple controls and clear status displays.” regulatory affairs VP Renato Moratore said in a prepared statement.

“The FDA clearance of this system builds on the reputation of Soterix Medical in providing equipment engineered to the highest medical device standards. The IontoDC technology is proven to provide exceptionally reliable and consistent performance.” CTO Dr. Abhishek Datta said in a press release.

Last September, Soterix Medical said it won Health Canada approval for and launched its PainX transcranial direct current stimulation technology designed for treating pain disorders in adults.

The PainX tDCS system is a non-invasive, battery-powered device designed to deliver mild current to a specific section of the cerebral cortex to modulate reaction to painful experiences or control pain perception, Soterix said. The company touted the device as a “highly-promising therapy” that avoids systemic side effects associated with oral pain medications.

Crospon wins FDA 510(k) for next-gen Endoflip system


Endoscopic diagnostic company Crospon said today it won FDA 510(k) clearance for its next-gen Endoflip system with Flip topography module, designed to allow clinicians to assess patient motility disorders during endoscopy.

The newly cleared Endoflip 2.0 system includes imaging software that displays esophageal contractility patterns in real time on a touch screen display, the Ireland-based company said.

“This clearance represents a significant milestone for our organization as we can now offer physicians an additional tool that can be used during endoscopy, along with other diagnostic methods, to evaluate patients with symptoms consistent with gastrointestinal motility disorders” CEO & founder John O’Dea said in a prepared statement.

The system allows operating clinicians to investigate for conditions including achalasia, GEJ outflow obstruction and other major or minor peristalsis disorders during endoscopy, as well as the ability to capture and store Endoflip images in patient records.

“The stand out benefit of this application, for both patients and caregivers, is that the Flip Topography assessment can be performed in less than five minutes during upper endoscopy on a sedated patient. In addition to significantly reducing discomfort, the patient may not have to wait for testing at a specialized center, thereby reducing their time to treatment. While not always a substitute for manometry, Endoflip 2.0 can reveal situations of non-obstructive dysphagia which may benefit from further evaluation from manometry,” O’Dea said in a press release.

Crospon said it will begin shipping the Endoflip 2.0 systems in June.