Blog Tag: FDA Approvals

Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza

Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib), AstraZeneca’s

FDA Planning Board Emphasizes Use of Data Sharing in Medical Device Monitoring

The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says 

FDA Issues Proposed Guidance for Changes to Medical Device Software

FDA Issues Proposed Guidance for Changes to Medical Device Software

The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices.  The proposed guidance relates to requirements for submitting medical device software

FDA Approves AspireAssist Obesity Device

FDA Approves AspireAssist Obesity Device

On June 14, 2016, the U.S. Food and Drug Administration approved AspireAssist, an obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.  According to a press release

FDA Approves First App-Based Pacemaker Monitor

Medtronic, a medical device manufacturer based in Dublin, Ireland, recently announced FDA approval and U.S. commercial launch of its MyCareLink Smart Monitor, the first app-based remote monitoring system for implantable pacemakers.

NuVasive Receives First-Ever 510(k) Clearance for a Cervical Corpectomy Cage

NuVasive Receives First-Ever 510(k) Clearance for a Cervical Corpectomy Cage

Spinal device specialist NuVasive recently received section 501(k) FDA clearance for its X-Core Mini Cervical Expandable VBR System, a titanium vertebral-body replacement device used in the cervical spine to replace vertebral bodies

Shifts in the Regulatory Landscape

Regulatory approval of medical devices is a significant consideration for any innovator or manufacturer of medical technologies.  The U.S. FDA’s regulatory approval processes, including, for example, 510(k) clearances and PMA

Hacking the Human Body – Medical Device Security

Medical device development, as always, is shooting upwards – and it has just reached the clouds.

According to News Medical, Verizon just announced that it received 510(k) clearance for its Converged Health Management medical device

ResMed Announces FDA Clearance of Noninvasive Ventilation Device for COPD Treatment

ResMed announced recently that the FDA had recently cleared its home variable positive airway pressure (VPAP) device for treatment of respiratory disorders such as chronic obstructive pulmonary disease (COPD).  According to its press

FDA Clearance for Monteris Medical Ablation System

Today’s Medical Developments reports that Monteris Medical‘s second generation MRI-guided ablation device, the “NeuroBlate System,” has just received FDA 510(k) clearance.

According to the press release,

ABL Medical Launches SilvrSTAT® in U.S.

ABL Medical, LLC has announced the official launch of its SilvrSTAT® Antibacterial Wound Dressing Gel in the U.S.

According to the press release, SilvrSTAT® is based on the company’s patented nano-molecular silver technology and has

FDA Approves TouchPACS Imaging Software Suite

DMH International announced today that its subsidiary, Touch Medical Solutions, Inc. (TMSI), has received approval from the United States Food and Drug Administration for TMSI’s “TouchPACS” medical imaging

FDA Approves Wellaho Mobile Monitoring Platform

Sanitas, Inc., announced today that it received approval from the United States Food and Drug Administration for its Wellaho system.  According to its press release, Wellaho’s Personalized Outpatient Management System™

FDA Approves Second Sight’s Argus II Retinal Prothesis System

NewsMedical reports that the FDA has approved Second Sight Medical Products’ Argus II Retinal Prosthesis System, an implanted device to treat patients with advanced retinitis pigmentosa.  According to the story:

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