FDA Device Approvals

FDA clears obstructive sleep apnea implant to overcome adherence issues

Sleep is like sex. Everybody wants it and nobody is getting enough. That’s what Lars Knutsen of Requis Pharmaceuticals said the other day as part of a presentation for a snoring and sleeplessness treatment. But it’s just as relevant for the 18 million people who deal with obstructive sleep apnea. Although continuous positive airway pressure […]

Verizon gets FDA clearance to expand remote monitoring platform to iOS users

Verizon has received FDA clearance that will expand a physician-facing patient engagement tool to capture patient data between office visits to the iOS network, according to a company statement. The majority of physicians using mobile devices tend to be iPhone and iPad users. The Converged Health Management platform is a cloud-based tool that transmits patient […]

Sponsored Post

Physician Targeting Using Real-time Data: How PurpleLab’s Alerts Can Help

By leveraging real-time data that offers unprecedented insights into physician behavior and patient outcomes, companies can gain a competitive advantage with prescribers. PurpleLab®, a healthcare analytics platform with one of the largest medical and pharmaceutical claims databases in the United States, recently announced the launch of Alerts which translates complex information into actionable insights, empowering companies to identify the right physicians to target, determine the most effective marketing strategies and ultimately improve patient care.

Devices & Diagnostics

Texas medical device company scores FDA nod for hammertoe fixation system

San Antonio, Texas-based BioMedical Enterprises received FDA clearance for its HammerLock Nitinol Intramedullary Fixation System upgrade. The system’s original innovation? No wires. The upgrade has a linear body that allows more bone fusion at the joint, which according to a company statement, offers “enhanced flexibility in positioning and easier reduction.” The implant is made of Nitinol, a […]

Devices & Diagnostics

FDA to 23andMe: Stop selling spit kits

Star startup 23andMe got slammed with an FDA warning letter Nov. 22. The letter says the healthcare startup’s genetic testing spit kits are being marketed without clearance or approval. It goes so far as to say the diagnostics applications, including “carrier status,” is a medical device usage, and therefore requires premarket approval or de novo […]

Devices & Diagnostics

BSX scores FDA device approval for drug-eluting stent for coronary artery disease patients

Boston Scientific (BSX) received FDA device approval for its Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, a next-gen polymer drug-eluting stent. The product launches immediately in the U.S. It will be used to treat patients with coronary artery disease. The company boasts the system offers “unparalleled visibility, low recoil, exceptional radial strength and fracture resistance, […]