Two women have filed a class-action lawsuit against Allergan (NYSE:AGN), alleging that the company’s textured breast implants gave them a rare form of cancer. Separately, a California judge dismissed two lawsuits against Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide over injuries allegedly caused by Mentor’s silicone breast implants. In the suit against Allergan, a woman […]
Implants
ESC Congress 2019: Biotronik beats Abbott at target lesion failure
Biotronik said yesterday that its Orsiro stent tops the Xience stents made by Abbott (NYSE:ABT) when it comes to target lesion failure, according to data from a clinical trial. The randomized, controlled BioSTEMI trial was the first direct comparison between the two drug-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI). Biotronik announced […]
FDA clears 4Web Medical’s cervical spine implant
4Web Medical said yesterday that it received FDA 501(k) clearance to market its cervical spine truss system-stand alone (CSTS-SA) interbody fusion device. The CSTS-SA contains a single-step locking mechanism designed to give surgeon users confidence in a stand-alone construct that is meant to place fixation screws through the truss implant and into adjacent vertebral bodies, […]
Senseonics touts long-term safety data on home-use Eversense
Senseonics (NYSE:SENS) yesterday touted real-world data it said demonstrated the safety and lack of adverse events with its Eversense continuous glucose monitoring system for people with diabetes. Eversense is a long-term, implantable GCM sensor with a transmitter that sends discreet vibrations to alert users of low or high glucose. The device can be removed, recharged and […]
Bone Solutions, Onkos ink private label deal
Bone Solutions said today that it entered into a private label licensing agreement with Onkos Surgical for its OsteoCrete bone void-filling technology. Colleyville, Texas-based BSI’s OsteoCrete is an FDA 510(k)-cleared magnesium-based injectable, moldable solution designed to attaching ligaments and tendons to bone and bone to bone. Parsippany, N.J.-based Onkos Surgical intends to market OsteoCrete under the […]
J&J’s Ethicon loses pelvic mesh appeal in Pennsylvania
The Pennsylvania Supreme Court has upheld a $2.43 million verdict against Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon in a pelvic mesh injury case. Sharon Beltz and her husband, Walter Beltz Jr. of Pen Argyl, Penn., won the verdict in 2017 based on their complaint that Sharon Beltz had suffered injuries due to mesh erosion and […]
These 5 DIY medical devices might surprise you
Big ideas in medical device development can come from regular people driven to solve vexing problems. Here are a handful of folks from outside the medtech industry who decided to create devices to solve their own health troubles or those of others around the world. Read on to see what high school, college and medical […]
Senseonics touts real-world CGM data
Senseonics (NYSE:SENS) announced yesterday that real-world data from its Eversense continuous glucose monitoring system reflected strong performance and safety. The data, published in Diabetes Technology and Therapeutics, included the first 205 U.S. patients to use Germantown, Md.-based Senseonics’ Eversense system over a 90-day wear period. Zero device or procedure-related adverse events were reported with the […]
NuVasive launches Modulus TLIF-A porous titanium implant
NuVasive (NSDQ:NUVA) yesterday announced the commercial launch of the Modulus TLIF-A, used in the transforaminal lumbar interbody fusion procedure. The Modulus TLIF-A is an anteriorly-placed porous titanium spine implant designed to promote bone in-growth and bone on-growth. “The Modulus TLIF-A system is the perfect synergy between optimized material properties and deliverability,” Dr. Jeffrey Gum, of […]
Restoration Robotics lands CE Mark for hair restoration system
Restoration Robotics (NSDQ:HAIR) said it has received CE Mark approval for the sale of the Artas iX system designed forf hair restoration. The CE Mark approval follows the company’s receipt of ISO 13485:2016 certification for Artas iX in January 2019. The Artas iX robotic hair restoration system has a three-camera stereoscopic vision system with 44-micron […]
WishBone Medical inks deal to distribute Bone Solutions OsteoCrete
WishBone Medical confirmed a private label distribution agreement with Bone Solutions, Inc. (BSI) for worldwide rights within pediatric orthopedics to license and sell OsteoCrete. OsteoCrete, a magnesium-based bone void filler, is designed to assist with bone repair and regeneration. It is the first device of its kind in the orthopedic market with 510(k) approval from […]