On Dec. 13, 2016, the Breakthrough Devices provisions were added to the Food, Drug, and Cosmetic Act through section 3051 of the 21st Century Cures Act. This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating […]
10 companies to check out at BIOMEDevice San Jose
BIOMEDevice San Jose is an opportunity for thousands of medtech engineers and executives to come together and network. The annual event, created by UBM, is an industry showcase that allows various medtech manufacturers and suppliers to tout their expertise. This year’s event takes place at the San Jose Convention Center in San Jose, Calif., Dec. 6 […]
New harmonized standards for medical devices, IVD in Europe
By Stewart Eisenhart, Emergo Group The European Commission has issued updated lists of harmonized standards for medical devices and in-vitro diagnostic (IVD) products in the Official Journal of the European Union (OJEU). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]
The FAQs on encryption, FIPS 140 and medical devices
By Stewart Eisenhart, Emergo Group As cybersecurity vulnerabilities become a more urgent concern for the medical device industry, encryption requirements are emerging as a key tool to address medical device cybersecurity concerns. In the US, compliance with the FIPS 140-2 standard can help manufacturers of network-connected devices and software demonstrate encryption capabilities able to protect […]
7 medtech stories we missed this week: Nov. 17, 2017
From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Skyline Medical launches JV deal with Helomics Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. […]
Conducting clinical research in medical device studies using a quality systems approach
FDA is encouraging a quality systems approach to conducting clinical trials. The Clinical Trials Transformation Initiative (CTTI) established the Quality by Design initiative for clinical research. Patients and those who care for them want access to new drugs, devices, and biological products as quickly as possible, while also being assured that the benefits of these […]
Brazilian regulators propose easier market pathway for low-risk medical devices and IVDs
By Stewart Eisenhart, Emergo Group Medical device and IVD regulators in Brazil plan to loosen market access for low-risk devices and IVDs by introducing a notification-only registration system for these products. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
PIP breast implant scandal: A story that triggered change
In the healthcare industry, stories of patient harm can sometimes be the impetus for positive change. This was the case with the PIP breast implant scandal, where cost-cutting decisions that resulted in injuries eventually led to major regulatory updates. In 1965, plastic surgeon Henri Arion introduced breast implants to France. Jean-Claude Mas, a former butcher […]
Pros and cons of MDNR and MDMA medical device registration in Saudi Arabia
By Stewart Eisenhart, Emergo Group Now that Saudi Arabian medical device regulators have exempted some low-risk products from full registration requirements, qualifying manufacturers should consider whether standard or fast-track access to the Saudi market best suits their business needs. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
Value-based care: CMS’s new administrator wants more of it
Seven months into her tenure, CMS administrator Seema Verma is turning out to be highly supportive of value-based care models. In fact, she recently told an audience in Cleveland that she wants them implemented faster. The situation appears to dispel doubts that alternative payment models – such as Accountable Care Organizations or “comprehensive care” models for […]
FDA’s role in medical device cybersecurity
By: Suzanne Schwartz, M.D., M.B.A. Virtually every aspect of our lives – including our health – has gone digital. Medical devices from insulin pumps to implantable cardiac pacemakers are becoming more interconnected and, like computers and the networks they operate in can be vulnerable to security breaches. A computer virus or hack resulting in the loss […]