Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
By Stewart Eisenhart, Emergo Group
South Korea’s Ministry of Food and Drug Safety (MFDS) has made three significant amendments to the country’s Medical Devices Act that will affect some market registrants going forward.
AngioDynamics (NSDQ:ANGO) celebrated 2 regulatory wins this week, an FDA 510(k) clearance for its Xcela Plus Port family and a nod from Canadian regulators for its Smart Port Power-Injectable Ports.
Aethlon Medical (OTC:AEMD) said the FDA granted an investigational device exemption for a feasibility trial of its Hemopurifier device, designed to filter pathogens and cancer cells from human blood.
St. Jude Medical won approval in Japan for the 1st commercially available pacemaker and lead system deemed safe during a full-body, high-resolution MRI.
Japanese regulators cleared St. Jude Medical‘s (NYSE:STJ) MRI-safe pacemaker and lead devices, the 1st such devices commercially available there, according to the medical device company.
Total Under Review: 50
Total Active:15
Total On Hold: 35
Summary of PMA Supplements Under Review
Total Under Review: 613
Total Active: 437
Total On Hold: 176
A recent analysis of medical device cybersecurity tests shows that these devices are vulnerable to fairly straightforward hacking techniques, an increasingly serious concern as device security is directly tied to patient health and safety.
Neurostimulation devices maker EnteroMedics (NSDQ:ETRM) officially submitted its pre-market approval application to the FDA for review of the Maestro VBLOC neuro-blocking system in treatment of obesity, metabolic diseases and other gastrointestinal disorders.