China CFDA proposes regulatory framework for 3D-printed medical devices

Stewart Eisenhart, Emergo Group Medical device market regulators at the China Food and Drug Administration (CFDA) have published new guidance proposing registration requirements for devices produced via 3D printing or additive manufacturing. 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

Medical device startups: Here’s how you handle regulatory and reimbursement

The two “Rs” — regulatory and reimbursement — are critical elements of the environment in which a medical device product is developed. Bill Betten, Betten Systems Solutions This is the fourth in a series of articles that discusses the design of innovative products in the highly regulated medical environment.  But the “environmental” factors of regulatory and reimbursement actually

Medtech stories we missed this week: March 16, 2018

From Intricon expanding its manufacturing space to Arthrex signing a global distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intricon expands medical footprint Intricon announced in a March 13 press release that it has signed a 5-year lease that will secure 30,000 sq. ft of manufacturing

MDSAP certification expanded for Brazilian, South American medical device companies

By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has officially extended applicability of the Medical Device Single Audit Program (MDSAP) to domestic manufacturers as well as other companies based in South America. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s

Indian CDSCO releases FAQ on medical device rules

By Stewart Eisenhart, Emergo Group The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has published a new Frequently Asked Questions (FAQ) document to clarify industry questions regarding the country’s new medical device oversight system. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post

Rimsys launches software to help medtech companies manage regulatory changes

Startup company Rimsys (Pittsburgh) has launched its its first software solution that helps medical device companies effectively manage regulations around the world. Delays or blocks to medical devices entering the market can be caused by things like mismanaged information. Rimsys is trying to alleviate that problem with its software by giving them a platform that

Europe’s new MDR: Is it as scary as you might think?

The European Union’s regulation of medical devices appears to be increasing under the new Medical Device Regulation (MDR) going into effect, while U.S. FDA is easing off. In many ways, the E.U. and the U.S. are going in opposite directions when it comes to medical device regulation, said Michael Drues, a regulatory consultant based outside

Hacking pacemakers is good TV, but is it for real?

Worry less about bad people hacking pacemakers and other cardiac devices. Worry more about them disrupting hospitals’ communications networks. That’s the major message out of the American College of Cardiology’s Electrophysiology Council, which published an article about cardiac devices earlier this month in the Journal of the American College of Cardiology.  The idea that hackers might

Medtronic recalls 48 CRM devices on arcing risk

Medtronic (NYSE:MDT) informed physicians last month of a problem with 48 of its cardiac rhythm management devices that’s prompting a Class I recall of the devices. The recall affects cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators that were “sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading […]

Regulatory changes a top concern for medtech companies in 2018

Changing regulatory environments are a top concern for medtech industry professionals in 2018, according to a recent survey from Emergo Group (Austin, Texas). According to the survey, 68% of industry senior managers and executives said that changing regulatory environments is one of the biggest challenges their companies face. Europe is currently going through major regulatory

Medtronic wins FDA nod for smallest drug-eluting stent on U.S. market

Medtronic‘s (NYSE:MDT) 2.0-mm Resolute Onyx drug-eluting stent has won FDA approval and is set to launch in the U.S., making it the smallest device of its kind on the market. The stent is designed to treat patients with coronary artery disease who have small vessels. Interventional cardiologists often face challenges treating this patient group with […]

Webinar: What will E.U. market entry for medical devices look like in 2020?

Wednesday, March 21, 2018 2 p.m Eastern time / 11 a.m. Pacific time     The E.U.’s medical device regulatory system is undergoing a major overhaul. This webinar will provide an overview of common European Union market entry requirements under the current MDD and the new MDR. Additional MDR requirements regarding clinical evaluations will be reviewed

Eudamed accessibility for medical device regulators outside of Europe

By Ronald Boumans, Emergo Group The European Commission is considering extending access to the Eudamed medical device database to non-European regulators to boost sharing of device safety information, potentially creating a new global data exchange standard for the industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog

Solar Atmospheres receives MedAccred accreditation

Solar Atmospheres (Hermitage, Penn.) announced that it has received MedAccred Heat Treating accreditation. The company became the eighth plant internationally and fifth plant nationally to receive the certification. According to Performance Review Institute, MedAccred is an industry managed supply chain oversight program that focuses on patient safety. It ensures that requirements are met and helps identify

FDA removed 10% of medtech establishments from its registration database: Here’s why

David Lennarz, Registrar Corp. The U.S. FDA has removed 2,546 medical device establishments from its active registration database.  As of Feb. 19, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on Feb. 2. So why did FDA remove the registrations? Establishments are typically removed due to failure to renew their annual