Gynesonics submits 510(k) premarket notification for uterine fibroid treatment

Gynesonics announced that it has submitted its 510(k) Premarket Notification to the FDA for its Sonata System. The Sonata System is a uterus preserving, incision-free uterine fibroid treatment that was designed to treat fibroids transcervically with radiofrequency energy. “Submission of the 510(k) application is an important milestone for our company,” Chris Owens, president and CEO

Effective design considerations for medical device warning labels

By Michael Wiklund, Emergo Group Some people believe that warnings are useless; printed on medical devices only to offer legal protection. Indeed, manufacturers can and have been held liable for the “failure to warn,” and adding warnings neutralizes this claim. Get the full story here at the Emergo Group’s blog. The opinions expressed in this

New FDA guidance for dual submission 510(k) and CLIA waiver application for IVD companies

By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration explains requirements for in vitro diagnostic manufacturers to register for premarket notification using the agency’s Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application. Get the full story here at the Emergo Group’s blog. The opinions expressed in this

Omnia Medical receives FDA 510(k) clearance for vertebral body replacement system

Omnia Medical has received FDA 510(k) clearance for a vertebral body replacement (VBR) system for use in the thoracolumbar spine to replace collapsed, damaged or unstable vertebral body. The VBR system is manufactured from PEEK-Optima HA enhanced polymer through a collaboration with Jalex Medical on product development and regulatory activities and Invibio Biomaterial Solutions who

Medtech stories we missed this week: Dec. 8, 2017

From Minimus Spine’s European distribution deal to Stimwave receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Minimus Spine inks EU distribution deal Minimus Spine announced in a Dec. 4 press releasethat it has signed its first European distribution deal with Italian company Moss and

How BioSig is using plug and play as a medtech startup strategy

Startups, as a rule, should have a plan for their technology to grow. But it is rare that a medical technology startup aims to be plug and play, fitting into many therapeutic areas from cardio to Alzheimer’s to diabetes. BioSig’s Pure EP, an electrophysiology signal recording and processing system, could potentially provide valuable insight during

Biomaterials: Is there a better way for FDA to regulate them?

The medical device industry is pretty conservative when it comes to materials used in medical devices. That begs the question: Do we need a new FDA approval pathway for biomaterials? Mike Drues thinks the answer is “yes.” “It really will encourage companies to use new materials and not be hamstrung with materials that have been

FDA publishes final guidance for UDI direct marking requirements

David Lennarz, Registrar Corp. The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime. This is known as UDI direct marking. The

3D printing could expand medical device regulation: Here’s how

FDA today offered a clearer picture of how it plans to regulate the 3D printing of medical devices – including in non-traditional settings such as medical facilities and academic institutions. “In order to help ensure the safety and effectiveness of these products, we’re working to establish a regulatory framework for how we plan to apply

FDA’s Gottlieb updates on Puerto Rico and medical product shortages

FDA commissioner Dr. Scott Gottlieb provided an update today to the work that the agency is doing to help medical device manufacturers in Puerto Rico in the weeks following Hurricanes Irma and Maria. The FDA chief noted that even though some major medical product manufacturers have regained power, many firms continue to run on generator

FDA clears AliveCor’s KardiaBand ECG for Apple Watch

AliveCor said today that the FDA cleared its KardioBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation. First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display […]

Medtech stories we missed this week: Nov. 17, 2017

From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Skyline Medical launches JV deal with Helomics Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics.

Better medtech UDI management could be an app away

Boston-based 121nexus said it can solve UDI supply chain master data problems through image recognition technology. Experts say the best apps on the market are “peace of mind” apps. 121nexus aims to deliver that feeling with its scanner. The company launched a free scan app that can verify and “open up” GS1 and unique device

FDA puts Second Sight Medical’s next-gen Orion ‘bionic eye’ on the fast track

Second Sight Medical (NSDQ:EYES) said today that the FDA put its Orion “bionic eye” on the fast track to approval. The Orion device is a cortical visual prosthesis that uses a camera and a brain implant to bypass the optic nerve in visually impaired patients. The federal safety watchdog put the device on its expedited […]

Greenlight Guru adds Grow to quality management software platform

Greenlight Guru recently announced the introduction of its Grow software product to assist medical device companies with quality management after product launch. The Indianapolis-based company’s first product, Go, focused on helping medtech companies utilize design control, risk management and document management software to bring FDA and ISO-compliant medical devices to market in less time. Many