1. Intellijoint CE Mark for flagship hip navigation
Intellijoint surgical announced in an Oct. 4 press release that it has received CE Mark for its Intellijoint HIP System in Europe. The device is a 3D mini-optical navigation system that gives surgeons precise measurement for cup position, leg length and offset of total hip arthroplasty. It doesn’t require any pre-operative or intra-operative imaging and can be used with any implant manufacturer.
2. FDA clears Solta Medical’s Thermage FLX
Solta Medical has received FDA 510(k) clearance for its Thermal FLX system, according to an Oct. 4 press release. The system is designed to non-invasively smooth skin on the face, eyes and body and is one of the company’s newest technologies that reduces the appearance of fine lines and wrinkles on the body. The system featured patented radio frequency technology that creates a uniform heating effect in deep collagen-rich layers of the skin. The heating works to tighten existing collagen while stimulating more collagen to produce.
3. OBP wins Brazilian regulatory clearance for Onetrac
OBP Medical announced in an Oct. 4 press release that it has received regulatory approval from Brazil’s National Health Surveillance Agency to market its Onetrac. Onetrac is a single-use, cordless surgical retractor that has an LED light source and smoke evacuation channel. It gives users better access, illumination and exposure to tissue pockets or cavities during surgery.
4. DiscGenics gets FDA go-ahead for IDCT spine treatment
The FDA recently granted DiscGenics allowance to begin its clinical study for its IDCT product, according to an Oct. 3 press release. IDCT is a homologous, allogenic, injectable cell therapy that uses Discogenic Cells to create a non-surgical regenerative solution for treating patients with moderate degenerative disc disease (DDD). The FDA’s acceptance allows the company to start a prospective, randomized, double-blinded, multi-center clinical study to determine the safety and efficacy of the device.
5. Bio-Tissue inks Canadian distro deal for Prokera
Bio-Tissue announced in an Oct. 3 press release that it has signed an agreement with Bright Optical to bring its Prokera biologic corneal bandage devices to Canada. Bright Optical has been a distributor of eye care products since 2004 and is already a distributor for Bio-Tissue’s Cliradex and Cliradex Light.
6. Adhezion Biomedical gets FDA clearance for SecurePortIV
Adhezion Biomedical recently received FDA 510(k) clearance for its SecurePortIV catheter securement adhesive, according to an Oct. 3 press release. The SecurePortIV can be used with short-term or long-term vascular access devices to seal the catheter insertion site and protect patients from bloodstream infections. It features a cyanoacrylate formulation that is specifically designed to be used with vascular access devices. It can be applied to the skin under the hub of vascular access devices and it forms a film that helps hold the catheter to the skin while reducing movement of the catheter.
7. Patrona Med teams with Kopis to develop IoT-equipped infection detection system
Patrona Medical and Kopis announced in an Oct. 4 press release that the two companies have developed a partnership to improve the intervention and care for hospital-acquired infections. The partnership will assist with the detection of catheter-associated urinary tract infections in a timely manner. The Foley Garde solution from Patrona Medical has an automated interface between monitoring systems and care providers that helps improve detection time. While consulting Kopis, Patrona Medical used Zipit’s IoT connectivity and device management technologies to create secure, wireless connectivity and cloud-based management over a cellular network.