The FDA yesterday released draft guidance covering microneedling devices and what it considers to be a medical device under its purview. Microneedling devices are often touted as treatments for acne, scars, stretch marks and to generally increase the elasticity and healthiness of skin. The devices and procedures are often meant to be performed at home […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
7 medtech stories we missed this week: Sept. 15, 2017
From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to […]
GSK’s triple-med COPD inhaler wins recommendation for approval in EU
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that a European Medicines Agency panel recommended marketing authorization for the Trelegy Ellipta triple-combination inhaler for adults with COPD. The device uses fluticasone furoate, umeclidinium and vilanterol to help adults with COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. It’s also the […]
FDA cuts could threaten medtech innovation: Here’s why
The Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, says a top expert at Musculoskeletal Clinical Regulatory Advisers (MCRA). Glenn Stiegman, MCRA Innovation is a vital element of success for medical device companies. More than 6,500 U.S. companies are developing technologies that improve patient outcomes. This represents a potential […]
Abbott nabs U.K. reimbursement win for FreeStyle Libre CGM
Abbott (NYSE:ABT) said today that its FreeStyle Libre continuous glucose monitoring system will be available for reimbursement in the U.K., starting on Nov. 1. The company’s system is designed to automatically read glucose levels through a sensor that’s worn on the back of a person’s upper arm for up to 14 days, thereby eliminating routine finger […]
Senseonics wins CE Mark for Eversense XL glucose monitor
Senseonics (NYSE:SENS) said yesterday that it won CE Mark approval in the European Union for its Eversense XL continuous glucose monitor. The Eversense XL includes a glucose sensor designed to be implanted for 180 days and a removable smart transmitter that links with a mobile app for real-time glucose monitoring. Germantown, Md.-based Senseonics touts the sensor […]
Aethlon Medical wins FDA EAP designation for Hemopurifier
Aethlon Medical (NSDQ:AEMD) said today it received an Expedited Access Pathway designation for its Aethlon Hemopurifier designed for treating life-threatening viruses. The San Diego-based company said its Hemopurifier has been validated to capture a “broad spectrum of viruses that are highly glycosylated”, which includes lethal strains of pandemic influenza, mosquito-borne viruses and hemorrhagic viruses with no currently […]
Edap submits new FDA 510(k) for Focal One HIFU
Edap (NSDQ:EDAP) said today it submitted a new FDA 510(k) application for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer after withdrawing its previous application in July. The new application alllowed the France-based company to include a new set of clinical data, which it had decided to include following “advanced discussions” with […]
Did Congress just kill medical device innovation?
The Medical Device User Fee Amendments bill that Congress passed this year is more than an FDA fees hike for device companies; it could inhibit innovation, says Michael Drues, a regulatory consultant based outside Boston. That’s because MDUFA 2017 includes new user fees – about $23,000 for small companies and $93,000 for large companies – for requests […]
US DHS warns of vulnerabilities in Smiths Medical Medfusion 4000 infusion pump
The US Dept. of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team has released a warning over issues with Smiths Medical’s Medfusion 4000 wireless syringe infusion pump after discovering 8 cybersecurity vulnerabilities in the device. The notice is for versions 1.1, 1.5 and 1.6 Medfusion 4000 wireless syringe infusion pumps, according to the DHS […]
FDA to pilot new high-risk PMA for medical devices
The FDA is readying a pilot program to try and improve the pre-market approval process for high-risk medical devices later this month. The federal safety watchdog is seeking nine companies to participate in its Premarket Approval Application Critical to Quality program beginning Sept. 29 and running to either Dec. 31, 2018, or until nine PMAs […]