Occlutech said today that its eponymous atrial flow regulator device received CE Mark approval in the European market. The Occlutech AFR is an intra-atrial shunt designed be placed between the left and right atria to treat heart failure symptoms by decompressing abnormal intra-atrial pressure. In a release, the Germany-based company said malfunction of the left […]
Implants
J&J’s DePuy to acquire JointPoint hip navigation software
Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes said it agreed to acquire JointPoint and its surgeon-friendly navigation software for hip replacements for an undisclosed amount. Belleair Bluffs, Fla.-based JointPoint’s OneTrial software is designed to improve surgical outcomes in hip replacements by analyzing implant selection and positioning pre-surgical digital templating and case planning through non-invasive computer […]
LivaNova wins Medicare nod for nerve stimulation trial
Medicare has approved a LivaNova (NSDQ:LIVN) study of vagus nerve stimulation (VNS) to treat depression, the company said today. The Centers for Medicare and Medicaid Services accepted the London-based company’s protocol for a clinical trial to study the safety and effectiveness of adding VNS to traditional depression treatment in patients with treatment-resistant depression. Approval of […]
ESC Congress: Study shows bariatric surgery can improve cardiac outcomes in Type 2 diabetes
Bariatric or metabolic surgery can significantly lower the risk of major cardiovascular events among patients with Type 2 diabetes and obesity, according to a new clinical study released at the European Society of Cardiology Congress in Paris. The retrospective study followed 13,722 Type 2 diabetes patients who underwent bariatric surgery to lose weight or metabolic […]
Allergan sued over textured breast implants
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 […]
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 […]