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

August 11, 2017 By Danielle Kirsh Leave a Comment

[Image from unsplash.com]

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.

Hospital survey reveals front-line needs, desperate measures
Hospitals across the U.S. have begun resorting to unorthodox means of replacing or sanitizing personal protective equipment (PPE) and atypical sourcing of PPE and other supplies needed to fight the coronavirus pandemic, according to a government survey. The Department of Human Services’ Office of the Inspector General (OIG) conducted the random survey of 323 hospitals… […]
CDRH gives medtech manufacturers employee coronavirus safety tips
As certain medtech companies continue ramping up production of devices and components to fight the coronavirus, the FDA’s Center for Devices and Radiological Health (CDRH) on Sunday announced several tips to help protect medtech manufacturing employees from contracting COVID-19. In addition to frequent and thorough hand-washing, maintaining social distancing and avoiding face-touching, the agency urged… […]
Lin Engineering hastens manufacture of DC motors for fight against COVID-19
Lin Engineering — a designer and manufacturer of precision electric motors and motion systems — is prioritizing the production and supply of motors to support companies making medical devices critical in the treatment of COVID-19 patients. Morgan Hill, Calif.-based Lin Engineering said last week its highest priority is supplying motors to the makers of medical… […]
Nortech, Minnetronix may start building ventilators
Two Minnesota medtech contract manufacturers are taking a hard look at producing ventilators, including one from the plans that Medtronic made public last week to address the coronavirus outbreak. Maple Grove-based Nortech Systems (NSDQ:NSYS) told Medical Design & Outsourcing it is seriously considering starting to produce the machines based on the design specifications of Medtronic’s… […]
Materialise touts 3D-printed oxygen mask that could free up ventilators
Materialise announced today that it developed a 3D-printed device to convert standard hospital equipment into a mask to help patients breathe by creating positive pressure in the lungs. The Leuven, Belgium-based company’s Materialise NIP Connector is designed to give clinicians the ability to reduce the time that patients need access to ventilators and relieve the… […]
Plastikos implements bio-contamination testing and compliance under ISO 14698
Plastikos (Erie, Pa.) recently announced that it has implemented a formal bio-contamination testing and compliance system that’s in full compliance with ISO 14698-1 and ISO 14698-2 — a move the company described as paramount amid the COVID-19 pandemic. Plastikos and Plastikos Medical presently mold medical devices and parts within multiple ISO-7 certified cleanrooms. The new… […]
How 3D printing is enabling ventilator splitting
Amid the shortage of ventilators due to the COVID-19 pandemic, researchers are finding success using 3D printing to enable “ventilator splitting.” The search continues to go on for more machines, but there have already been government actions taken to increase amounts, while researchers have taken it into their own hands to create homemade-style ventilators. However,… […]
How R&D departments are coping with coronavirus
Hardly anyone’s R&D workplace has been spared all the repercussions of the COVID-19 crisis. People are working remotely, staggering their hours in laboratories to avoid too many coworkers, and relying heavily on conference calls and video meetings. Our WTWH Media sister site R&D World spoke to a few industry people to see how they’re coping… […]
Europe waives tariffs, import taxes on COVID-19 medtech
The European Commission has decided to waive tariffs and value-added taxes (VAT) on certain medical devices and personal protective equipment (PPE) coming from outside the EU during the coronavirus pandemic. The measure includes testing kits, ventilators and other medical equipment and will remain in force for six months, the commission said today. “In this emergency,… […]
FDA eases mask regulations, seeks to boost decontamination of used masks
The FDA yesterday further relaxed regulations on medical and surgical masks and face shields to ease shortages during the coronavirus pandemic, and invited companies that decontaminate masks to submit proposals for emergency authorizations. In a new guidance, the agency also gave its blessing to healthcare providers to use improvised masks during the public health emergency when… […]
BARDA opens research portal to fight COVID-19
By James Keller, Emergo Group The Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response, is seeking information from stakeholders on available medical countermeasures in development. It is particularly interested in products and technologies that have progressed into… […]