Early-stage orthopedics company Additive Orthopaedics said today it won FDA 510(k) clearance for its 3D printed, minimally-invasive, intramedullary bunion correction system. The Little Silver, N.J.-based company said the clearance was its 4th which leveraged additive manufacturing and 6th complete product line, including its 3D printed core products, biologics and custom equipment. “This new 3D printed implant […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
LivaNova wins expanded MR indication for VNS Therapy device
LivaNova (NSDQ:LIVN) said today it won FDA approval for expanded MRI labeling for its Vagus Nerve Stimulation Therapy device, touting it as the only epilepsy device cleared by the FDA for MRI scans. With the approval, patients with the minimally invasive VNS system are cleared to visit any MRI center in the US, with access to […]
Zimmer Biomet cleaned house after FDA inspection at Warsaw plant
Zimmer Biomet (NYSE:ZBH) told the FDA that it cleaned house after the federal safety watchdog’s inspection last year turned up numerous violations at a plant in Warsaw, Ind., replacing 5 operations and quality executives as it sought to bring the facility back into compliance. The FDA inspected the North Campus location in Warsaw just before Thanksgiving […]
Digital health devices: FDA’s plan for innovation
Dr. Scott Gottlieb, FDA commissioner It is incumbent upon FDA to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By taking an efficient, risk-based approach to our regulation, FDA can […]
J&J, Medtronic push back against TGA priority review proposal
Johnson & Johnson (NYSE:JNJ) and Medtronic (NYSE:MDT) are pushing back against the Australian Therapeutic Goods Administration’s proposed priority review pathway for medical devices, citing faults in the proposal that they claim will keep them from using it, according to a RAPS report. The major medtech players said they had doubts whether the pathway, designed to hasten approval, […]
CBO scores Senate’s FDA user fees bill
The Congressional Budget Office last week scored a U.S. Senate bill to re-up the user fee agreement between the medical device and pharmaceutical industries, saying it would add $740 million to the budget and a negligible amount to the deficit over 2017 to 2022. The “FDA Reauthorization Act of 2017” would see medical device companies put […]
Controlled-release ADHD drug wins FDA approval
Neos Therapeutics (NSDQ:NEOS) won FDA approval yesterday for its controlled-release formulation of an old ADHD drug, methylphenidate. The company touts its product, Cotempla XR-ODT, as the 1st methylphenidate tablet designed to release medication over time instead of all at once. Get the full story at our sister site, Drug Delivery Business News.
How to achieve better medical device outcomes through behavior change
Will Randall, ZS Associates I often pause in restaurant bathrooms, amused by the familiar signage above the sink: “Employees must wash hands before returning to work.” Surely everyone washes their hands. While these well-meaning but rather amusing signs are found all over the U.S., do they actually have any impact on improving hygiene practices? Probably […]
FDA clears Conformis’ iTotal hip replacement
ConforMIS (NSDQ:CFMS) said today it won FDA 510(k) clearance for its primary iTotal Hip replacement system. The iTotal Hip system features the company’s iFit technology which uses single-use, custom 3D printed instruments and a limited amount of reusable instruments to deliver a customized hip replacement, the Billerica, Mass.-based company said. “Standard hip replacement surgery can be challenging, […]
Intuitive Surgical wins FDA nod for inguinal hernia repairs with da Vinci Xi
Update: Removed information claiming benefits of robotic hernia surgeries at request of Intuitive Surgical, which said that the data came from an inaccurate source and was not valid. Intuitive Surgical (NSDQ:ISRG) said today it won FDA clearance for inguinal hernia repairs with its da Vinci Xi robotic surgical system. Inguinal hernias occur when tissue presses through […]
BD wins FDA nod for customizable mini-laparoscopic instruments
Becton Dickinson & Co. (NYSE:BDX) said today it won FDA 510(k) clearance for its line of Snowden-Pencer 3mm laparoscopic customizable surgical instruments. The line of Snowden-Pencer instruments are designed for micro-laparoscopic surgery and are intended to function like 5mm instruments, the Franklin Lakes, N.J.-based company said. Jaw lengths on the devices are designed to mirror […]