Blog Tag: Food and Drug Administration
The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). According to an FDA news release, the approved test is the
The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in patient care.
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
Globus Medical announced early today that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017.
Globus Medical, which
The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017. This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA. Previously, companies had to submit a report
Boston Scientific recently announced that it is launching a worldwide study for its EMBLEM™ MRI Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) device. According to the press release, a multicenter trail of the device
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
Security firm InfoArmor published a report in late July 2016 stating that a group of attackers infiltrated American health care institutions, stole at least 600,000 patient records and attempted to sell more than 3 terabytes of that associated
The FDA has just released draft guidance for unique device identifiers (UDIs) tracking medical devices from their manufacturers to the end users. Specifically, the FDA is providing guidance to device the content and form of UDIs that
On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices.
The draft guidance
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
A new blog post by The Food and Drug Administration (FDA) published earlier this month provides an update regarding the implementation of the year-old Expedited Access Pathway (EAP) program, which was created in April 2015 by the FDA’s
The Food and Drug Administration has proposed a new policy for earlier public notification of medical device safety issues. These notifications will be in addition to the recall notices, safety communications, and press releases the
FDA Approves Expanded Use of Medtronic’s CoreValve System; Also Receives Regulatory Approval in Japan
This week the U.S. Food and Drug Administration announced its approval of Medtronic’s CoreValve system for “valve-in-valve” (VIV) replacement. According to the FDA press release, this represents the first transcatheter
St. Paul, MN-based EnteroMedics Inc. recently announced that the Food and Drug Administration (FDA) approved the use of its VBLOC vagal blocking therapy, delivered via its Maestro system. The system is indicated for treatment of obese
The FDA issued a proposed order on March 22nd that, if finalized, could potentially toughen the approval process for manufacturers of automated external defibrillators (AEDs). Under the proposed order, manufacturers will now be required