New FDA guidance for dual submission 510(k) and CLIA waiver application for IVD companies

By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration explains requirements for in vitro diagnostic manufacturers to register for premarket notification using the agency’s Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application. Get the full story here at the Emergo Group’s blog. The opinions expressed in this

Medtech stories we missed this week: Dec. 8, 2017

From Minimus Spine’s European distribution deal to Stimwave receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Minimus Spine inks EU distribution deal Minimus Spine announced in a Dec. 4 press releasethat it has signed its first European distribution deal with Italian company Moss and

Biomaterials: Is there a better way for FDA to regulate them?

The medical device industry is pretty conservative when it comes to materials used in medical devices. That begs the question: Do we need a new FDA approval pathway for biomaterials? Mike Drues thinks the answer is “yes.” “It really will encourage companies to use new materials and not be hamstrung with materials that have been

FDA publishes final guidance for UDI direct marking requirements

David Lennarz, Registrar Corp. The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime. This is known as UDI direct marking. The

3D printing could expand medical device regulation: Here’s how

FDA today offered a clearer picture of how it plans to regulate the 3D printing of medical devices – including in non-traditional settings such as medical facilities and academic institutions. “In order to help ensure the safety and effectiveness of these products, we’re working to establish a regulatory framework for how we plan to apply

Medicare finalizes cuts to value-based healthcare programs

The Centers for Medicare & Medicaid Services yesterday finalized cuts to a trio of bundled payment pilot programs aimed at lowering healthcare costs and improving outcomes. The federal health insurer cut the Comprehensive Care for Joint Replacement Model, or CJR, effectively in half, from 67 geographic areas participating to 34, meaning about 470 hospital participants instead of 800. […]

FDA clears AliveCor’s KardiaBand ECG for Apple Watch

AliveCor said today that the FDA cleared its KardioBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation. First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display […]

Medical device startups: Here are the secrets of success

Bill Betten, Betten Systems Solutions It’s tough enough to be a startup developing and launching innovative products. For medical device startups, there’s the added burden of operating in a highly-regulated industry. The cost of developing a medical device ranges from $25 million to $100 million, according to a 2010 research study out of Stanford University.

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

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.

How to select sterile barrier systems for reusable medical devices

Sterile barrier systems are key components in medical device sterilization, so selecting the right barrier is essential. Jason Pope, Nelson Labs Reusable medical devices, prior to use in healthcare facilities, must undergo validation testing to demonstrate the effectiveness of the cleaning instructions and the microbiocidal instructions that will be provided to the healthcare facility. Often, the

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

FDA approves first pill with sensor to track ingestion

The FDA today approved Abilify MyCite, the first drug in the U.S. to have an ingestible sensor embedded within the pill that can track if the medication was taken. The drug-device combination product is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and as an […]

Trump nominates pharma insider Azar to lead HHS

The Trump administration today nominated Alex Azar, who spent nearly 10 years at Eli Lilly (NYSE:LLY) after working in the second Bush administration, as secretary of the U.S. Health & Human Services Dept. The former HHS head, Dr. Tom Price, resigned in September after days of fending off criticism over chartered flights he took on the public dime. […]