During the week of July 24, 2023, the FDA published several notifications of potentially elevated risks associated with medical devices, including a recall of a delivery sheath for the Amplatzer device by Abbott Laboratories. The agency also announced that Abiomed Inc. will provide a correction for the instructions for use (IFUs) for the Impella because of an issue seen when implanting the left ventricular assist device in patients with transcatheter aortic valve replacement (TAVR) devices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ultrasight.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Astrazeneca, Biohaven, Cessation, Defender, Jiangsu Recbio, Krystal, Precision.
Public companies registered with the U.S. SEC will soon have to disclose material cybersecurity incidents and annually report material information regarding their cybersecurity risk management, strategy and governance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ultrasight.
Beijing Tinavi Medical Technologies Co. Ltd.’s surgical robot received approval from China’s National Medical Products Administration (NMPA) for total knee replacement, expanding its product portfolio to cover spine, trauma and joints in orthopedic surgery. The new product, named Tirobot Recon, provides support for surgeons in total knee arthroplasty.
The U.S. FDA has issued a draft guidance for devices intended to address opioid use disorder (OUD), a problem with a massive public health footprint that has defied the efforts of public health programs. The draft guidance highlights some of the difficulties in executing pivotal studies for these devices, but the FDA’s July 27 press omits any mention of a 2018 innovation challenge for this category of devices, a programmatic effort that seems to have yielded little in the way of tangible results.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Anova, Denovo, Incannex, Innocare, Inozyme, Myopax, Octapharma, Opthea, Pint.
Continuing its efforts to reduce prescription drug prices in the U.S., the Senate Finance Committee turned up the heat on pharmacy benefit managers (PBMs), voting overwhelmingly, 26-1, to send the bipartisan Modernizing and Ensuring PBM Accountability (MEPA) Act to the full Senate.
Not hitting the primary endpoint of a phase III study caused the U.S. FDA to say it would not review Biohaven Ltd.’s NDA for troriluzole to treat spinocerebellar ataxia (SCA), an ultra-rare disorder.
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