FDA Breakthrough Devices Program

Since the Innovation Pathway program initiated in 2011, the Food and Drug Administration (FDA) has provided means to expedite its review process for groundbreaking products. While critics question how faster review cycles impact patient safety, one thing is clear…products approved under priority review suffer more quality issues.

More on that later. The latest incarnation of a priority review track is the Breakthrough Devices Program, the spiritual successor to the Expedited Access Pathway...

Breaking: Sweeping CMS Measures

Yesterday, CMS is made an announcement that they would be taking additional sweeping measures to empower the US healthcare system to meet challenges created by the COVID-19 pandemic. We summarize it here.

Increasing hospital capacity Normally, hospitals are required to administer services in their own buildings. CMS is now allowing hospitals to provide services in additional locations,...

Manufacturing Vital Medical Devices and Products During a Pandemic

In the words of a York resident, “Have you heard of the York Plan? That’s us. We pretty much saved the world.”1 The setting was bucolic York County, Pennsylvania. The appropriately named “York Plan” was a 15-point initiative created by W. S. Shipley in the late 30’s to re-train workers, pool resources and coordinate production […]

In the words of a York resident, “Have you heard of the York Plan? That's us. We pretty much saved the world.”1 The setting was...

Getting Ahead of the Coronavirus Curve with Telehealth and Remote Care

We’ve discussed how robot-assisted care is one of the best ways to ensure that our healthy populations, including healthcare providers, don’t unnecessarily expose themselves to Coronavirus. Social distancing attempts to ensure that healthcare providers aren’t overloaded. This is a mitigation approach that, according to a study by Imperial College, may reduce peak healthcare demand by […]

We’ve discussed how robot-assisted care is one of the best ways to ensure that our healthy populations, including healthcare providers, don’t unnecessarily expose themselves to...

Centers for Medicare and Medicaid Expands Telehealth Benefits

In the latest step to encourage “social distancing”, an isolation technique meant to slow the rapid spread of COVID-19, the Centers for Medicare and Medicaid (CMS) announced expanded telehealth benefits for Medicare participants. Before the announcement, medicare participants were only allowed to access remote healthcare services for routine checkups. This means the most vulnerable populations […]

In the latest step to encourage "social distancing", an isolation technique meant to slow the rapid spread of COVID-19, the Centers for Medicare and Medicaid...