The SEC announced today that it levied a complaint against Parallax Health Sciences and two top executives for making allegedly misleading statements about COVID-19-related products. Without admitting or denying the allegations, Parallax, its CEO Paul Arena, and CTO Nathaniel Bradley consented to judgments permanently enjoining them from future violations of the charged provisions and requiring […]
Smith+Nephew launches Fast-Fix Flex meniscal repair system
Smith+Nephew (LSE:SN;NYSE:SNN) announced today that it launched the Fast-Fix Flex meniscal repair system. London-based Smith+Nephew touts its Fast-Fix Flex meniscal repair system as the only device to offer a surgeon-guided, bendable needle and shaft to provide access to all zones of the meniscus, resulting in long-term benefits to the patient, according to a news release. […]
Conformis, Stryker settle in Wright Medical patent infringement litigation
Conformis (NSDQ:CFMS) announced today that it settled with Stryker (NYSE:SYK) to resolve patent litigation involving Wright Medical. Billerica, Mass.based Conformis said in a news release and SEC filing that Stryker — which acquired Wright Medical in November 2020 — will make a one-time $15 million payment to Conformis. Stryker in return will receive a non-exclusive license […]
Surmodics acquires Vetex Medical and its mechanical thrombectomy catheter
Surmodics (NSDQ:SRDX) announced that it acquired Vetex Medical, a developer and manufacturer of venous clot removal solutions. Buying Galway, Ireland–based Vetex Medical provides Surmodics a second FDA-cleared device for its thrombectomy portfolio. Vetex designed the ReVene thrombectomy catheter to remove large, mixed-morphology blood clots commonly found with venous thromboembolism (VTE). Get the full story at our sister […]
Explorer Surgical expands offerings into robotic surgery space
Explorer Surgical announced today that will expand its cloud-based digital platform into the robotic surgery space. As a result of the foray into surgical robotics, medical robotics companies will now be able to leverage the Explorer Live digital platform and procedural playbook, video capabilities and data collection offerings to improve workflow and performance. Get the […]
Siemens Healthineers wins FDA clearance for Magnetom Free.Max MR scanner
Siemens Healthineers (ETR:SHL) announced today that it received FDA clearance for the Magnetom Free.Max magnetic resonance (MR) scanner. The German medtech giant developed the High-V MR scanner to combine a 0.55 Tesla field strength with deep learning technologies and advanced image processing to broaden the range of MR clinical applications, according to a news release. […]
Fresenius Kabi launches Simplist fentanyl citrate injection
Fresenius Kabi announced today that it initiated the U.S. introduction of a fentanyl citrate injection in the Simplist pre-filled syringe. Lake Zurich, Ill.-based Fresenius Kabi’s proprietary Simplist ready-to-administer prefilled syringe offers the fentanyl citrate injection at 50 mcg per 1 mL in an effort to reduce waste and diversion while ensuring the safe delivery of medication. […]
Medtronic has a Class I recall of some angiographic guidewires
The FDA has classified the recall of some angiographic guidewires made by Medtronic (NYSE:MDT) as Class I, the most serious kind. Medtronic’s angiographic guidewire component affected by the recall helps place catheters into the vasculature during angiography or other interventional procedures. The recall occurred because of a lack of sterilization before shipment to hospitals, according […]
MedTech 100 roundup: New all-time best reached
Once again, the medtech industry has soared to new heights, eclipsing its all-time best performance by the tiniest of margins. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (July 2) at 114.59 points. It was just 0.01 points ahead of the 114.58-point mark set in […]
Levita Magnetics announces first magnetic robot-assisted surgeries
Levita Magnetics announced today that it performed the first procedures with its robot-assisted surgical platform. Dr. Ignacio Robles used Menlo Park, Calif.–based Levita’s newest system, the Levita Robotic Platform, in a reduced-incision laparoscopic cholecystectomy (gallbladder removal). The procedure took place at Clínica INDISA in Santiago, Chile, as part of a clinical study of the platform. […]
Outset Medical CFO to leave, interim replacement named
Outset Medical (NSDQ:OM) announced that CFO Rebecca Chambers will step down and Nabeel Ahmed will take over in an interim capacity. San Jose, Calif.-based Outset said in a news release that Chambers will depart to pursue other opportunities, effective on July 16, 2021. Ahmed, current VP of finance at the company, will assume the role […]