The FDA today warned of issues associated with contaminated SPS-1 static organ preservation solution from Organ Recovery Systems. The solution is intended for the flushing and cold storage of the kidney, liver and pancreas at the time of organ removal from the donor to prep for storage, transportation and eventual transplantation. Staff at a healthcare […]
Surgical
PolyPid wins FDA designation for antibiotic drug reservoir
Pharmaceutical company PolyPid said today that its D-Plex antibiotic drug reservoir won Qualified Infectious Disease Product status from the FDA. Under the designation, the Israel-based company’s product will be eligible for priority review, fast-track status and an additional 5 years of market exclusivity. Get the full story at our sister site, Drug Delivery Business News.
Ethicon goes ahead with Enseal X1 launch
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon is going ahead with the launch of its Enseal X1 instrument, despite an ongoing dispute with its longtime rival in the surgical cutting and sealing market, Medtronic (NYSE:MDT) subsidiary Covidien. “Enseal X1 is the latest example of how Ethicon is advancing technology to give surgeons greater control, access, and accuracy during surgical procedures […]
Study: Dextera touts shorter hospital stays for MI lobectomy procedures using its MicroCutter stapler
Dextera Surgical (NSDQ:DXTR) today released data from a small study of patients who underwent microlobectomy procedures utilizing its MicroCutter surgical stapler, touting hospital stays at least 2 days lower than open lobectomy procedures. “The interest in the presentation at the meeting reflects the global interest in technologies like the MicroCutter 5/80 that enable less invasive approaches […]
Via Surgical inks distro deal with Progressive Medical for FasTouch
Via Surgical said today it inked an exclusive US distribution deal with Progressive Medical to distribute Via’s FasTouch soft tissue suture device. Amirim, Israel-based-based Via Surgical’s FasTouch is designed for the fixation of prosthetic material to soft tissue, providing lockable, flexible suture-like fixation for procedures such as hernia repairs. “The FasTouch System provides innovation in hernia […]
7 medtech stories we missed this week: March 3, 2017
Several clinical study results were published this week, while other companies reached distribution deals. Here are 7 medtech stories we missed this week but were still worth mentioning. 1. Health Canada approves Ventripoint’s complete heart analysis system for 2D ultrasounds Ventripoint Diagnostics received a license from Health Canada for its new VMS-Plus machine and the 4-chamber […]
Cydar lands Roche exec for 3D imaging software play
Cydar EV, a medical software start-up, said this week that it hired several new directors, including Roche’s recently-retired chairman Franz Humer. The U.K.-based company is developing cloud-based software to produce 3D images of a patient’s blood vessels in X-ray guided endovascular surgery. Cydar said Humer will bring a “wealth of commercialization” and key developmental insights […]
Amend Surgical wins FDA nod for NanoFuse BA bone graft extender
Amend Surgical said today that it won 510(k) clearance from the FDA to market its NanoFuse BA as a bone graft extender for spine and orthopedic indications. The Alachua, Florida-based company’s NanoFuse BA is a composite of bioactive glass and a human demineralized bone matrix that Amend Surgical touts as providing optimal surgical handling performance […]
Surgical Nav group Scopis wins FDA, Health Canada nod for ENT nav system
Surgical navigation and augmented reality company Scopis Medical said today it won FDA 510(k) clearance, as well as Health Canada approval for its next-gen surgical navigation designed for ear, nose and throat surgery. Cambridge, Mass.-based Scopis designs surgical navigation systems using augmented reality technology, with real-world imaging data enhanced by integrated computer-generated images. “Scopis currently provides […]
LifeBond launches pivotal LifeSeal sealant trial
Tissue repair-focused developer LifeBond said today it launched a pivotal study of its LifeSeal surgical sealant kit, set to explore the use of the sealant in patients undergoing colorectal anastomosis. The Israel-based company’s LifeSeal surgical sealant kit includes a specific gastrointestinal sealant designed to minimize staple-line leakage during gastrointestinal resection procedures. “LifeBond’s team is committed to bringing […]
Orthocell touts CelGro nerve regeneration study
Orthocell (ASX:OCC) touted interim data today from an ongoing clinical study of its CelGro collagen soft tissue repair device for peripheral nerve regeneration. Researchers are evaluating the safety, tolerability and effectiveness of CelGro in surgery with patients who have suffered injury to 1 or more peripheral nerves in the hand and upper limb. The company said that […]