Blog Tag: FDA Approvals
The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices.
The FDA describes
According to the press release, the BrainsWay Deep
Akili Interactive recently announced results of a trial on the company’s digital medicine product, AKL-T01. According to FierceBiotech, Akili plans to file AKL-T01 with the U.S. Food and Drug Administration (FDA) for clearance
According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s Orthopedic Branch for its minimally invasive bone stabilizaion system
According to the press release, the Speedboat RS2 device and the associated
The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone with
It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency. Below is a brief summary of some recent of Medtronic’s
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
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
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
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
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.
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
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
Medical device development, as always, is shooting upwards – and it has just reached the clouds.
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
According to the press release,
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
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
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™