Health Canada said it will now accept certain clinical trial submissions in electronic common technical document format. Accepted submissions will include clinical trial applications, pre-clinical trial application consult meetings, amendments and notification, and responses and post-clearance data related to such applications.
The FDA has unveiled a 10-page draft guidance consolidating its recommendations on nonclinical immunotoxicity safety assessments for new drugs, therapeutic proteins and recombinant/plasma-derived blood proteins. It does not cover biologics, adjuvanted vaccines and cell and gene therapies.
KinetiCor's Motion Correction System, used in conjunction with Siemens Healthineers' MAGNETOM Skyra 3T MRI scanner, has been given 510(k) clearance by the FDA. The program is designed to help reduce the need for repeat MRI scans due to unintentional movement.
A Class I recall has been issued for 398,320 of Teleflex's Comfort Flo humidification systems because of a malfunction that causes water to flood the column and circuit. The water can then enter the patient's nose and lungs.
Abbott is partnering with Insulet to combine its FreeStyle Libre glucose sensor with the latter's Omnipod Horizon automated insulin delivery system. FreeStyle will gather data on the user's glucose levels and send it to the Omnipod via Bluetooth for an automatic adjustment of insulin administration.
Integer Holdings has purchased Israel-based medical device manufacturer Inomec. With the acquisition, Integer adds catheter design, clinical and pilot manufacturing capabilities, and it is planning an R&D and sales center in Israel.
India-based Panacea Medical Technologies will build its North American headquarters in Noblesville, Ind. The facility will serve as an engineering and manufacturing site for radiotherapy machines used to detect and treat cancer, as well as a research and development center.
Abbott's Gallant implantable cardioverter-defibrillator and CRT-D devices have been given CE mark approval by European regulators. The devices are designed for use with Abbott's mobile app myMerlinPulse to improve patient-doctor interaction and allow remote patient monitoring.
The FDA has given Acutus Medical clearance for the SuperMap software program addition for its AcQMap 3D imaging system. The heart mapping algorithm helps electrophysiologists to diagnose and treat stable and transient arrhythmia.
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