A new FDA discussion paper addresses cybersecurity issues specific to the servicing of medical devices, with the goal of guiding the conversation about potential challenges and opportunities. It coincides with a larger agency initiative to provide more clarity on servicing.
It’s not unusual for women to have some uterine contractions during pregnancy. Many of these go unnoticed, but others can be strong and feel like labor. Distinguishing between normal contractions and those that are not can help ensure women at risk of preterm labor get the extra medical care they need. To that end, Tel Aviv-based Nuvo Group Ltd. has launched an FDA-cleared uterine activity (UA) module on its Invu remote monitoring platform.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Hecin, Holista Colltech.
Biogen Inc.’s $56,000-a-year list price for its newly approved Alzheimer’s drug, Aduhelm (aducanumab), is sending tremors through the prescription drug pricing debate that could shift the epicenter of those discussions to drugs granted accelerated approval based on surrogate endpoints.
Shares in Orphazyme A/S cratered after the FDA rejected its arimoclomol for Niemann-Pick disease type C, a rare and potentially fatal inherited condition where fat builds in tissues and organs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acelrx, Agenus, Amneal, Applied Therapeutics, Blueprint, Eagle, Innocare, Novartis, Sirnaomics, Turning Point, Xilio.
The FDA responded on Thursday to longtime industry calls for the agency to clarify the distinction between the “serving” and “remanufacturing” of a medical device with new draft guidance to provide consistency and a better understanding of the applicable statutory and regulatory requirements. The 35-page document details its current thinking on the distinction.
With the advent of wearable digital health technologies, patient-generated health data (PGHD) will play an increasingly central role in evidence generation for medical device companies. Speakers on a recent FDA workshop advised that there are several barriers to the use of PGHD for evidence generation, however, such as the perennial headache of data interoperability and a new twist on the question of patient trust, problems that are likely to plague the field for the foreseeable future.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elekta, Neo Medical, Neuralace.
The U.S. Supreme Court, in a 7-2 opinion dismissing a challenge to the Affordable Care Act (ACA), removed a threat to the future of the Biologics Price Competition and Innovation Act (BPCIA) and the biosimilars pathway it created.