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The FDA has announced a new testing tool, and approved several systems for cryoablation, donor lung preservation and cervical disc replacement. Read More
This European Edition of Quick Notes includes a Swissmedic study of drug approval times, $16 million awarded by UK Innovate, an announcement by Roche of phase 3 anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) preliminary results and an Access to Medicine Foundation report on antimicrobial resistance and responsible manufacturing. Read More
Although unanimously endorsing the safety of Medtronic’s Symplicity Spyral Multi-electrode Renal Denervation system, members of the FDA’s Circulatory System Devices Panel were split on both the efficacy and risk/benefit balance of the ultrasound-powered device, intended to treat hypertension by ablating sympathetic nerves in the renal arteries. Read More
Intarcia Therapeutics will continue its seven-year quest for FDA approval of its drug-device diabetes treatment with an alternative form of hearing — a public hearing before an advisory committee on Sept. 21to discuss CDER’s refusal to approve the product. Read More
Recent clearances and approvals of medical devices include not just new versions of existing products, but entirely different ways to provide care for both complex illnesses and common needs. Read More
This first European Edition of Quick Notes includes a PDUFA date extension for a chikungunya vaccine candidate, NICE approved AI technologies for radiotherapy treatment therapies, Novartis cited for claims made on an Entresto podcast and comments on the EU proposal for compulsory licensing. Read More
BD has received 510(k) clearance for both remediation and return to full commercial operations of its updated Alaris infusion pump system, which was subject to an FDA class I recall in 2020, the most serious type of recall as use of the device may lead to serious injury or death. Read More