510(k)

Devices & Diagnostics

Atlanta medical device company lands $11M to launch smart materials orthopedics technology

MedShape, Inc., an Atlanta, Ga.-based medical device company, announced it closed an $11 million funding round that will go toward a full-market launch of the Eclipse Soft Tissue Anchor. The product, made from proprietary thermoplastic, is a shape-memory, soft-tissue repair device that allows surgeons to attach tendons, ligaments or soft tissue to bone. Its shape both […]

Devices & Diagnostics

No catheter, no cuff: FDA clears Sotera Wireless’ continuous noninvasive blood pressure technology

No more catheter, no more cuff for monitoring patient vital signs? Sotera Wireless announced the FDA has given 510(k) clearance to its continuous non-invasive blood pressure (cNIBP) technology, a new feature of its ViSi Mobile patient monitoring system. “For the first time clinicians can continuously monitor all patient vital signs, including beat-to-beat blood pressure, without the […]

Devices & Diagnostics

Tennessee medical device company gets FDA nod for Occlusion Perfusion Catheter

Chattanooga, Tenn.-based Advanced Catheter Therapies received FDA 510(k) clearance for its Occlusion Perfusion Catheter, a multi-lumen balloon catheter on Tuesday. The medical device technology can measure pressure inside the treatment chamber, as well as “its inflow  and outflow ports for chamber evacuation, filling and flushing,” according to a press release. The catheter is designed to […]

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Devices & Diagnostics

Will this 2013 Innovation of the Year device change the standard of care for port site closures?

The standard of care for port site closures in laparoscopic surgery may be changing. Irish medical device startup neoSurgical‘s first commercialized product, neoClose, officially launched this week in the U.S. Today, the Society of Laparoendoscopic Surgeons named the device one of the 2013 Innovations of the Year at the SLS Minimally Invasive Surgery Week Annual Meeting. […]

Devices & Diagnostics

BSX gets FDA approval for ablation catheter, becomes third major player this week with ablation milestone

Boston Scientific (BSX) announced it has received U.S. Food and Drug Administration approval for its IntellaTip MiFi XP catheter and 501(k) clearance for its Zurpaz 8.5F steerable sheath, growing its EP mapping/ablation technology portfolio. This makes it the third major player–following both St. Jude Medical, which acquired Endosense, and GE, which invested in Acutus Medical–to […]

Devices & Diagnostics

Boston-based company gets FDA clearance for noninvasive monitor aimed to help trauma-care clinicians treat patients in shock

Reflectance Medical, Inc. has received FDA 510(k) clearance for a noninvasive device that could help clinicians determine whether a patient is in shock or pre-shock or has tissue acidosis in real time at the point of injury or care. It’s the only noninvasive pHm monitoring device, and aims to save providers money by reducing ICU […]

Devices & Diagnostics

Minnesota device group files citizen petition to prevent FDA from unlawfully changing 510(k)

A Minneapolis law firm has filed a joint petition on behalf of a group of pre-revenue, small and midsized device companies, venture capitalists and inventing physicians that aims to prevent the U.S. Food and Drug Administration from unlawfully changing how the 510(k) program operates. The Minnesota Medical Device Alliance (MMDA) filed the citizen petition and […]